Anaconda AAA Stent Graft System

Instructions for Use

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English Instructions For Use 4

Franais Mode Demploi 20

Deutsch Gebrauchsanweisung 38

Nederlands Gebruiksaanwijzing 56

Italiano Instruzioni Per LUso 76

Espaol Instrucciones De Uso 94

Portugus Instrues de Utilizao 112

Svenska Bruksanvisning 130

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Dansk Brugsanvisning 160

Norsk Bruksanvisning 178

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esky Nvodkpouit 214

Magyar Hasznlatitmutat 232

Polski Instrukcjauycia 250

Slovenina NvodNaPouitie 268

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Lietuvikai Naudojimo instrukcijos 304

Trke KullanmTalimatlar 322

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Srpski Uputstvo za upotrebu 358

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CONTENTS

SECTION 1 INSTRUCTIONS FOR USE11 Anaconda Stent Graft System Components12 Indications13 Contraindications14 Cautions15 Patient Counselling and Adverse Events16 Training17 Preparation for Implant18 Anaconda Stent Graft System Sizing and Selection19 Patient Follow up110 Magnetic Resonance Imaging Safety111 Disposal112 Returning a Used Anaconda Stent Graft System 113 General Guidelines for the Preparation of the Anaconda Stent Graft System

SECTION 2 INSTRUCTIONS FOR DEPLOYMENT Stage 1a Anaconda Bifurcate Body Delivery System PreparationStage 1b Ipsilateral Guidewire ProcedureStage 1c Anaconda Bifurcate Body Delivery System Introduction & PositioningStage 2 Cannulation of Contralateral Lumen of the Anaconda Bifurcate BodyStage 3a Anaconda Iliac Leg or Flared/Tapered Iliac Leg PreparationStage 3b Contralateral Anaconda Iliac Leg or Flared/Tapered Iliac Leg Introduction & DeploymentStage 4 Anaconda Iliac Leg or Flared/Tapered Iliac Leg Extension Introduction & DeploymentStage 5 Deployment of the Anaconda Bifurcate BodyStage 6 Anaconda Ipsilateral Iliac Leg or Flared/Tapered Iliac Leg Introduction & DeploymentStage 7 Smoothing of the Anaconda Bifurcate Body Stent Graft Fabric and Smoothing & Modelling of the Iliac LegsStage8 CompletionAngiographyandVerificationofStentGraftPlacementandSeal

SECTION 3 BAILOUT PROCEDURES

SECTION 4 DEPLOYMENT SCHEMATICS

SECTION 5 EXPLANATION OF SYMBOLS ON PRODUCT LABELLING

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SECTION 1: INSTRUCTIONS FOR USEThis booklet provides instructions for the routine use of the Anaconda and Anaconda ONE-LOK Stent Graft Systems (subsequently both Systems are referred to as Anaconda Stent Graft System) Similarly for iliac leg, this can refer to straight, flaredortaperedconfigurations.Forfurtherinformationregardingsizing,pleaserefertotheAnacondaorAnacondaONE-LOKStent Graft System Sizing Chart (included within the product packaging) For unexpected events during the deployment procedure, please consult Section 3 of this IFU: Bailout Procedures

1.1 ANACONDA STENT GRAFT SYSTEM COMPONENTS Anaconda Stent Graft System bifurcate body Anaconda ONE-LOK Stent Graft System bifurcate body Iliac legs Flared Iliac legs Tapered Iliac legs Aortic extension cuff (see separate IFU)

Anaconda Bifurcate Body Delivery System

1 Sheath Diameter2 Nose Cone3 Radiopaque Marker4 Blue Sheath Slider5 Blue Control Collar6 Handle7 White & Blue Release Clips (Wires)8 White Stopcock

9 White Flushing Port10 Intrinsic Magnet Guidewire11 Torque Device12 Blue Stopcock13 Blue Guidewire Port14 Overall Length15 Sheath Length16 Compacted Body Device

Anaconda Iliac Leg Delivery System

1 Sheath Diameter2 Nose Cone3 Radiopaque Marker4 Blue Sheath Slider5 Handle6 Blue Release Clips (Wire)

7 White Flushing Port8 Blue Guidewire Port9 Overall Length10 Sheath Length11 Compacted Iliac Leg Device

COMPACTED ILIACLEG DEVICE

BLUE SHEATH SLIDER

HANDLE

BLUE RELEASE CLIP (WIRE)

WHITE FLUSHING PORT

BLUE GUIDEWIREPORT

SHEATHDIAMETER

SHEATH LENGTH

OVERALL LENGTH

NOSE CONE

RADIOPAQUEMARKER

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3

4

5

6

7

8

9

10

11

NOSE CONE

COMPACTED BODYDEVICE

BLUE SHEATH SLIDER

BLUE CONTROL COLLARHANDLE

WHITE & BLUE RELEASECLIPS (WIRES)

WHITE FLUSHING PORT

BLUE GUIDEWIREPORT

SHEATHDIAMETER

SHEATH LENGTH

OVERALL LENGTH

RADIOPAQUEMARKER

TORQUE DEVICE

WHITE STOPCOCK

BLUE STOPCOCK

INTRINSIC MAGNETGUIDEWIRE

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3 45

6

7

89 10

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14

13

12

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Anaconda Flared/Tapered Leg Delivery System

1 Sheath Diameter2 Nose Cone3 Radiopaque Marker4 Blue Sheath Slider5 Fixed Collar6 Handle

7 Blue Release Clips (Wire)8 White Flushing Port9 Blue Guidewire Port10 Overall Length11 Sheath Length12 Compacted Flared/Tapered Iliac Leg Device

Anaconda Bifurcate Body (ONE-LOK Illustration)

1 Contralateral Radiopaque Markers2 Peak Hook3 Leg Docking Radiopaque Markers4 Contralateral Cannulation Flare with Radiopaque Markers5 Distal Radiopaque Marker

6 Flow Splitter7 Secondary Ring8 Valley Hook9 Proximal Ring

COMPACTED FLARED/TAPEREDILIAC LEG DEVICE

BLUE SHEATHSLIDER

FIXED COLLARHANDLE

BLUE RELEASE CLIP(WIRE)

WHITE FLUSHINGPORT

BLUE GUIDEWIREPORT

SHEATHDIAMETER

SHEATH LENGTH

OVERALL LENGTH

NOSE CONE

RADIOPAQUEMARKER

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3 4

56

7

8

9

10

12

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1

2

3

45

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Anaconda Iliac Leg

1 Proximal Radiopaque Marker2 Individual Ring Stents with Radiopaque

Alignment Markers3 Distal Radiopaque Marker

Anaconda Flared Iliac Leg

1 Proximal Radiopaque Marker2 Transition Marker3 Distal Radiopaque Marker

Anaconda Tapered Iliac Leg

1 Proximal Radiopaque Marker2 Transition Marker3 Distal Radiopaque Marker

1.2 INDICATIONS: The Anaconda Stent Graft System is indicated for the repair of infra-renal abdominal aortic aneurysm (AAA), having:

Proximalaorticnecklengthof15mminlengthwithnon-significantcalcificationand/ornon-significantthrombus Native proximal aortic neck diameters of 160-310mm for Anaconda or 175-310mm for Anaconda ONE-LOK Proximalaorticinfra-renalneckangulationof90 Adequate iliac or femoral vessel access Please refer to the Anaconda or Anaconda ONE-LOK Stent Graft System

Sizing Chart for delivery system French (Fr) size Native iliac artery diameters of 85-210mm Distalfixationlengthof20mm Morphology suitable for Endovascular Aneurysm Repair (EVAR)

1.3 CONTRAINDICATIONS: The Anaconda Stent Graft System is contraindicated for:1 Ruptured aneurysm2 Juxtarenal, pararenal, suprarenal or thoracoabdominal extension of the aneurysm3 Clinically serious concomitant medical disease or infection4 Connective tissue diseases (eg Marfans Syndrome)5 Known allergy to nitinol, polyester, tantalum or polyethylene6 Knownallergytocontrastmedium,whichcannotbeadequatelypre-medicated.Patientswithpre-existingrenalinsufficiencymay

have an increased risk of renal failure postoperatively7 Excessive tortuosity of access vessels (femoral or iliac arteries)8 Pregnant or nursing mothers9 Patients

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1.5 PATIENT COUNSELLING AND ADVERSE EVENTS

PATIENT COUNSELLING Theclinicianshouldreviewallassociatedrisksandbenefitswhencounsellingthepatientaboutthisendovasculardeviceandallassociated proceduresThese include but are not limited to:

patient age and life expectancy risksandbenefitsrelatedtoopenrepair risksandbenefitsrelatedtoendovascularrepair risks related to non-interventional treatment or medical management risk of aneurysm rupture compared to endovascular repair possibility that subsequent endovascular or open repair of the aneurysm may be required the long term safety and effectiveness of the Anaconda Stent Graft System has not been established long term monitoring requirements

VascutekLtd.recommendsthattheclinicianinformthepatientofallassociatedrisksandbenefits,inwrittenform.Details regarding risks occurring during or after implantation of the device are provided in the Potential Adverse Events section

POTENTIAL ADVERSE EVENTSAdverse events that may occur and/or require intervention include, but are not limited to:

Amputation Anaesthetic complications and subsequent attendant problems (eg, aspiration) Aneurysm enlargement Aneurysm rupture and death Aortic damage, including perforation, dissection, bleeding, rupture and death Arterial or venous thrombosis and/or pseudoaneurysm Arteriovenousfistula Bleeding, haematoma or coagulopathy Bowel complications (eg, ileus, transient ischaemia, infarction, necrosis) Cardiac complications and subsequent attendant problems (eg, arrhythmia, myocardial infarction, congestive heart failure,

hypotension, hypertension) Claudication (eg, buttock, lower limb) Death Oedema Embolisation (micro and macro) with transient or permanent ischaemia or infarction Endoleak Feverandlocalisedinflammation Genitourinarycomplicationsandsubsequentattendantproblems(e.g.,ischaemia,erosion,fistula,incontinence,haematuria,

infection) Hepatic failure Impotence Infection of the aneurysm, device access site, including abscess formation, transient fever and pain Lymphaticcomplicationsandsubsequentattendantproblems(e.g.,lymphfistula) Neurologic local or systemic complications and subsequent attendant problems (eg, confusion, stroke, transient ischaemic

attack, paraplegia, paraparesis, paralysis) Occlusion of device or native vessel Pulmonary/respiratory complications and subsequent attendant problems (eg, pneumonia, respiratory failure, prolonged

intubation) Renalcomplicationsandsubsequentattendantproblems(e.g.,arteryocclusion,contrasttoxicity,insufficiency,failure) Stent graft issues: improper component placement; incomplete component deployment; component migration; suture

break;occlusion;infection;stentfracture;grafttwistingand/orkinking;insertionandremovaldifficulties;graftmaterialwear;dilatation;erosion;punctureandperigraftflow

Surgical conversion to open repair Vascularaccesssitecomplications,includinginfection,pain,haematoma,pseudoaneurysm,arteriovenousfistula,dissection. Vascular spasm or vascular trauma (eg, iliofemoral vessel dissection, bleeding, rupture, death) Vessel damage Wound complications and subsequent attendant problems (eg, dehiscence, infection, haematoma, seroma, cellulitis)

DEVICE RELATED ADVERSE EVENT REPORTINGAny adverse event involving the Anaconda Stent Graft System should be immediately reported to Vascutek Ltd using either the email address complaints@vascutekcom or via your local distributor

1.6 TRAININGCAUTION: Clinicians must have received training and have established clinical experience in vascular interventional pro-cedures prior to using the Anaconda Stent Graft System. Prior to use of the Anaconda Stent Graft System, clinicians should complete the Anaconda Stent Graft System Training pro-gramme provided by Vascutek Ltd which includes, but is not limited to, device training,case planning & bailout procedures Vascutek Ltd offers clinical training support for Anaconda Stent Graft System implants

Vascutek Ltd provides training in the use of the Anaconda Stent Graft System prior to use Training sessions can be scheduled with the principal members of the operating team, which include practical demonstration and experience of an Anaconda Stent GraftSystemdeploymentinamodelusingfluoroscopiccontrol.Furthermore,itistheresponsibilityoftheimplantingclinicalteamtoensure that the team has combined procedural experience of:

Femoral cutdown, arterial bypass, arteriotomy and repair

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Percutaneous access and closure techniques Non-selective and selective guidewire and catheter techniques Fluoroscopic and angiographic image interpretation Embolisation Angioplasty Endovascular stent placement Snare techniques Appropriate use of radiographic contrast material Techniques to minimise radiation exposure Expertise in necessary patient follow-up modalities

Fluoroscopy must be available at the scheduled training sessions and all principal members of the team must attend the session

1.7 PREPARATION FOR IMPLANTADDITIONAL COMPONENTS SUPPLIED SEPARATELY

Contralateral Magnet Guidewire Flexible Contralateral Magnet Guidewire Non-magnetic Ultrastiff Guidewire Contralateral Guiding Catheter (8Fr)

EQUIPMENT REQUIRED (NOT PROVIDED WITH THE ANACONDA STENT GRAFT SYSTEM) Fluoroscopic imaging and the ability to record and recall all images Appropriately sized introducer sheaths to provide an adequate conduit for the Anaconda Stent Graft System delivery

system Sterile introducer sheaths for introduction into the femoral arteries during road mapping for further diagnostic imaging Anassortmentofguidewiresandintroducersheathsof8Fr An assortment of guidewires appropriate for access vessels and interventional techniques Selection of patient-appropriate sized non-compliant and compliant balloons to enable potential dilatation of the blood

vessels prior to implant or post deployment ballooning of the stent graft Interventional endovascular snare devices Heparinised saline Power injector for angiographic contrast studies Radiopaque contrast media Radiopaque calibrated angiography catheter Selection of appropriate peripheral stents

GENERAL GUIDELINESOptimize device planning and selection by a thorough pre-operative assessment of the aneurysm anatomy and surrounding vascu-latureinordertosizeforanappropriatedevicethatfitsthepatientsanatomy.Appropriatesizingofthedeviceremainstheresponsi-bility of the clinician Sizing of the aorta and of the iliac vessels must be determined before the implant takes place using a contrast enhanced CT and/or angiogram This information must be available during the implantation of the Anaconda Stent Graft SystemThe main body of the Anaconda Stent Graft System should be oversized by 10-20% and the total device length is recommended from the lowest renal artery to just above the origin of the internal iliac (hypogastric) artery bifurcation

Itshouldbenotedthatwhendeployed,duetotheflexibilityoftheAnacondaStentGraftSystem,theoveralllengthofthedevicemay be shorter than expected due to angulated or tortuous anatomy

STERILISATIONThe Anaconda Stent Graft System is sterilised by ethylene oxide; it is supplied sterile and must not be re-sterilised Any damage to the packaging may render the product non-sterile In the event of damage to the packaging, the product must not be used and should be returned to the supplier

1.8 ANACONDA STENT GRAFT SYSTEM SIZING AND SELECTION

Correct sizing and device selection is the responsibility of the implanting clinician A contrast enhanced CT scan which is no more than4monthsoldtodateofimplant,withaslicethicknessof3mm,shouldbeusedwhencaseplanning.

The Anaconda Stent Graft System Sizing Charts are provided as a separate documents to the Anaconda Stent Graft System IFU, and can be found contained within the product packaging, to assist in the accurate selection of the Anaconda Stent Graft System components

The Anaconda Stent Graft System Sizing Charts have been devised using the internal vessel diameter (ID) measurements; therefore no further calculations are required If the outside vessel diameters (OD) are measured then an allowance for the vessel wall diameter must be made before using this table for device selection

The Anaconda and Anaconda ONE-LOK Stent Graft System Sizing Charts: Provide Anaconda Stent Graft System bifurcate body and iliac leg device sizing for optimal sealing Incorporates a 10%-

20% oversize of ring stent diameter to aortic diameter No further oversize is required Vascutek Ltd has performed testing and recommends that a 10% oversize will provide optimum sealing of the excluded aneurysm

Details the range of Anaconda Stent Graft System bifurcate body to iliac leg device compatibility Demonstrates the length of the iliac leg device necessary to achieve the required length for aneurysm exclusion Additional iliac leg length and increase or decrease in diameter should be selected in accordance with the appropriate Anaconda Stent Graft System Sizing Chart

IdentifiesaccessvesselsuitabilityfortheAnacondaStentGraftSystem At the time of surgery, Vascutek Ltd recommends the clinician have available:

o At least one extra Anaconda Stent Graft System of the same size as the one intended for implant in case the device is damaged during device preparation or implantation

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o At least two extra Anaconda Stent Graft Systems, one a size smaller and one a size larger than the one intended for implant in case the original measurement of the vessel size has been over or under estimated

1.9 PATIENT FOLLOW UPRegular follow-up including imaging of the Anaconda Stent Graft System should be performed in accordance with the standard of care of the treating hospital/clinician Patients should be monitored on a regular basis for aneurysm growth, occlusion of vessels within the treatment area, pulsatility, migration, endoleaks and device integrity

1.10 MAGNETIC RESONANCE IMAGING SAFETY

The Anaconda Stent Graft System was determined to be MR conditional (ie according to information provided in the following document: American Society for Testing and Materials (ASTM) International, Designation: F 2503-08)

Clinicians implanting the Anaconda Stent Graft System should follow Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

Non-clinical testing demonstrated that the Anaconda Stent Graft System is MR Conditional A patient with the Anaconda Stent Graft System can be scanned safely, immediately after placement under the following conditions:

-Staticmagneticfieldof3-Teslaorless-Maximumspatialgradientfieldof720-Gauss/cmorless-Maximumwhole-body-averagedspecificabsorptionrate(SAR)of3-W/kgfor15minutesofscanning

In non-clinical testing, the Anaconda Stent Graft System produced a temperature rise of less than or equal to 20C at a maximum wholebodyaveragedspecificabsorptionrate(SAR)of3-W/kgfor15-minutesofMRscanningina3-TeslaMRsystem(Excite,HDx,Software 14XM5, General Electric Healthcare, Milwaukee, WI)

MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the Anaconda Stent Graft System

1.11 DISPOSALAt the end of the procedure care must be taken to ensure safe disposal of the Anaconda Stent Graft System delivery system Each operating team must ensure local and national regulatory requirements for the disposal of contaminated clinical waste products is adhered to In the event of open surgical conversion after an Anaconda Stent Graft System implant, the surgeon and the surgical team perform-ingtheexplantmusttakecaretoavoidtheriskofpotentialinjuryresultingfromthesharpdevicefixationhookspositionedattheringstent peaks and valleys

1.12 RETURNING A USED ANACONDA STENT GRAFT SYSTEM All explanted devices and/or delivery systems should be returned to Vascutek Ltd. for analysis as soon as possible.In the event of a used delivery system needing to be returned to Vascutek Ltd, it is a requirement to have the delivery system, and any other items used in the procedure to be returned in an explants box which can be obtained from Vascutek Ltds Quality Assur-ance Department If required, explant kits can be requested at complaints@vascutekcom or through your local distributor and will be provided for the retrieval and preservation of explanted stent grafts and/or delivery systems or other components for transit to Vascutek Ltd

1.13 GENERAL GUIDELINES FOR THE PREPARATION OF ANACONDA STENT GRAFT SYSTEM A vascular surgical team must be available immediately in the event of need for emergency open surgical conversion It is recommended practice to ensure patients are heparinised for the duration of the endovascular procedure to avoid

thromboembolism Do not kink or excessively bend the system after removal from the packaging AnacondaStentGraftSystemrepairofAbdominalAorticAneurysmrequiresaccuratefluoroscopicimaging.Useofthe

AnacondaStentGraftSystem isnot recommended forpatientswhoseweightmay impede thequalityoffluoroscopicimaging

The delivery systemmust be flushed thoroughly at the guidewire and flushing portswith approximately 30ml of sterileheparinised saline to purge air from the system

During system preparation the system sheath slider must not be retracted The sheath slider must only be retracted when the device has been positioned in the aorta The sheath slider allows the compacted stent graft to be opened fully into the aorta

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SECTION 2: DEPLOYMENT PROCEDUREThese Instructions for Use must be used in conjunction with the Deployment Schematics located in Section 4.

NEVER ADVANCE, MANIPULATE OR WITHDRAW EQUIPMENT IN THE VASCULATURE WITHOUT THE USE OF FLUOROS-COPY

Step Stage 1a. Anaconda Bifurcate Body Delivery System Preparation

1Remove the Anaconda bifurcate body delivery system from the sterile packaging and place it on a sterile table while the device is still in its clear plastic tray Take care not to excessively bend or kink the outer sheath whilst handling the delivery system

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First,flushtheblueguidewireportwith30mlofsterileheparinisedsaline,thenturnoffthebluestopcock.Flushthewhiteflushingportwith30mlofsterileheparinisedsaline,andthenturnoffthewhitestopcockoftheflushingport Finally, open the blue stopcock of the guidewire port to allow passage of the guidewire

3Wet along the full length of the delivery system sheath with sterile heparinized saline Ensure the sheath remains wet throughout the procedureThe Anaconda bifurcate body delivery system is now ready for use

4 Ensure visualisation of the device markers and orientation of the device prior to insertion into the arterial system

Step Stage 1b. Ipsilateral Guidewire Procedure

1 Introduce a standard 0035 guidewire into the ipsilateral arterial access point using chosen standard access techniques

2 Introduce a pigtail angiography catheter over the standard 0035 guidewire

3 Remove the standard 0035 guidewire

4 Consider performing angiography

5 Introduce an appropriate ultrastiff 0035 guidewire through the angiography catheter

6 Remove the angiography catheter over the ultrastiff 0035 guidewire

Step Stage 1c. Anaconda Bifurcate Body Delivery System Introduction & Positioning

1 Ensure that the Anaconda bifurcate body delivery system is prepared as instructed in the Anaconda bifurcate body delivery system preparation section (Stage 1a)

2 Advance the Anaconda bifurcate body delivery system over the 0035 ultrastiff guidewire

3 Ensurethecontralateralradiopaquemarkersareinthecorrectorientationbyvisualisingthemarkersunderfluoroscopy.See Anaconda Bifurcate Body diagram in Section 1.

4 Advance the delivery system until the peaks of the proximal ring stent are positioned below the renal arteries with the contralateral radiopaque markers in the correct orientation Figure 1.

5 Perform angiography with delivery system in situ to ensure aortic anatomy has not been altered by introduction of the delivery system Figure 1.

6Stabilise the delivery system handle Gently retract the control collar fully to achieve a controlled deployment The control collar should be held in this fully retracted position At no point should you use excessive force. Slowly pull back the sheath slider completely to withdraw the outer sheath and expose the Anaconda bifurcate body Figure 2 & 3.

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Gently advance the control collar fully forward until the Anaconda bifurcate body is positioned in the target landing zone At this point the bifurcate body remains attached to the delivery system Figure 4.CAUTION: It is not recommended to use balloons, snares or any other adjunctives whilst the Anaconda bi-furcate body is still attached to the Anaconda delivery system as they may interfere with the release of the control sutures.

8 Consider performing angiography to verify the Anaconda bifurcate body is in the target landing zone

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If repositioning is required the Anaconda delivery system handle gives full control of the top ring stents on the bifurcate body to allow for precise repositioning of the ring stent in the targeted landing zone To reposition the Anaconda bifurcate body:

1 Close the ring stent by retracting the control collar fully2 Advance the system 3-4mm to ensure the stent graft hooks are clear of the aortic wall3 Hold the control collar in the fully retracted position and reposition the stent graft Ensure the peaks of the proximal ring stent are positioned below the renal arteries and the contralateral markers are in the correct orientation Figure 5.CAUTION: Avoid excessive rotation of the bifurcate body delivery system greater than 900 in either direction. Ensure the control collar is fully forward and the Anaconda bifurcate body is positioned in the target landing zone At this point the bifurcate body remains attached to the delivery system Figure 6.

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10 Consider performing angiography to verify the Anaconda bifurcate body is now in the target landing zone

11The Anaconda delivery system handle must now be stabilised, to ensure that the Anaconda delivery system does not rotate or move The Anaconda bifurcate body is now unsheathed but remains attached to the delivery system until Stage 5

Step Stage 2. Cannulation of Contralateral Lumen of the Anaconda Bifurcate Body

1 Stabilise the Anaconda bifurcate body delivery system throughout Stage 2

2 Introduce a standard 0035 guidewire into the contralateral arterial access point

3 Advance the 8Fr contralateral guiding catheter (CLGC) over the standard 0035 guidewire until the radiopaque tip is positioned close to the aortic bifurcation Figure 7.

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Exchange the standard 0035 guidewire for the contralateral magnet guidewire of choice The standard contralateral magnetguidewire(CLMW)canbeusedinstraightanatomyandtheflexiblecontralateralmagnetguidewire(FCLMW)can be used in selected tortuous anatomy Note: If the FCLMW is used, exchange for an ultrastiff 0035 guidewire will be required prior to introduction of the con-tralateral iliac delivery system Note: The pre-loaded intrinsic magnet is designed to move on the intrinsic magnet guidewire Normally this will only occur in the intrinsic magnet guidewire withdrawal process However, under certain circumstances, the intrinsic magnet mould maymoveprematurelyifitmeetsanobstructionsuchasananatomicalledgeorfocalcalcification.Thewidenedsectionat the end of the intrinsic magnet guide wire prevents the magnet mould coming off the end of the guidewire

5 Manipulate the torque device on the intrinsic magnet guidewire and the contralateral magnet guidewire until the two magnets connect Figure 7.

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When the magnets have connected, carefully advance both magnet guidewires simultaneously until the magnets are visualised above the tip of the Anaconda bifurcate body nose cone Figure 8. Note: Ensure the ipsilateral magnet guidewire is not accidentally withdrawn from the bifurcate body during magnet wire manipulationNote: Ensure approximately 20mm of the intrinsic magnet guidewire remains distal to the delivery handle If the guidewire magnets disconnect during advancement through the Anaconda bifurcate body, care must be taken to reconnecttheguidewiremagnetsoutsidethebifurcatebody,2-3mmbelowthelevelofthecontralateralcannulationflareto minimise the risk of passing through a bifurcate body control sutures CAUTION: It is important to ensure the floppy tip of the intrinsic magnet guidewire remains above the level of the proximal ring stent at all times during the cannulation procedure

7Todisconnectthemagnets,fixthecontralateralmagnetwireandadvancetheintrinsicmagnetguidewirethefinal20mm.CAUTION: This procedure must take place at the level of the tip of the Anaconda bifurcate body nose cone. Figure 9.

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Withdrawtheintrinsicmagnetguidewireuntil thefloppytipisbelowthecontralateralcannulationflare.Asthemagnetslidesalongthewiretherewillbeasmallamountofresistance.Thisproceduremustbevisualisedunderfluoroscopicguidance tovisualise that themagnetmouldhas reached thefinalpositionat thewidenedsectionon theendof theintrinsic magnet guide wire Figure 10.

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Note: If the FCLMW has been used, it must be exchanged for an ultrastiff 0035 guidewire before advancing the contral-ateral iliac leg delivery system Re-insert the inner dilator through the contralateral guiding catheter and advance the contralateral guiding catheter to the tip of the bifurcate body nose cone over the FCLMW Remove inner dilator and the FCLMW and exchange for an ultrastiff 0035 guidewireNote: The magnet at the end of the FCLMW is a larger diameter than the inner dilator therefore removal of the wire should take place from the proximal end of the dilator

Step Stage 3a. Anaconda Iliac Leg and Flared/Tapered Iliac Leg Preparation

1Remove the Anaconda leg delivery system from the sterile packaging and place it on a sterile table while the device is still in its clear plastic tray Take care not to excessively bend or kink the outer sheath whilst handling the delivery system

2 Firstflushtheguidewireportwith30mlofsterileheparinisedsaline.Followingthis,flushthewhiteflushingportwith30mlofsterileheparinisedsaline,andthenturnoffthewhitestopcock.

3Wet along the full length of the delivery system sheath with sterile heparinised saline Ensure the sheath remains wet throughout the procedure The Anaconda leg delivery system is now ready for use

4 Ensure visualisation of the Anaconda leg markers and orientation of the device prior to insertion into the arterial system

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Step Stage 3b. Contralateral Anaconda Iliac Leg or Flared/Tapered Iliac Leg Introduction & Deployment

1 When working on the contralateral side, ensure the Anaconda bifurcate body is stabilised throughout Stage 3

2

Ensure that the leg delivery system is prepared as indicated in the leg delivery system preparation section 3a CAUTION: The control collar on any of the leg delivery systems will be fixed and cannot be used to reposition the leg device. The leg delivery system handle must be stabilised whilst unsheathing to prevent shortening of device and redundant fabric, increasing the risk of thrombus developing. The release wire must not be removed before the device is fully unsheathed as this could result in breakage of the release wire.

3Advance the leg delivery system over the contralateral magnet guidewire CAUTION: If the FCLMW has been used, it must be exchanged for a ultrastiff 0.035 guidewire before advancing the leg delivery system. Figure 11a.

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Visualise the radiopaque docking markers on the Anaconda bifurcate body and the proximal marker of the leg device Note:Flared/taperedlegshaveanadditionalradiopaquemarkerwhichidentifiesthetransitionzonebetweentheflared/tapered and straight segments of the leg device See Anaconda Iliac Leg diagrams in Section 1. Figures 11a & 11b.CAUTION: Do not retract the outer sheath until the position is satisfactory in relation to the Anaconda bifurcate body docking markers, i.e. when the proximal marker of the leg device is 2-3mm above the proximal radiopaque docking marker of the Anaconda bifurcate body.

5 Considerperformingangiographytoconfirmthepositionofthelegdeviceisinthetargetlandingzone.CAUTION: the distal radiopaque marker should be at least 5mm proximal to the internal iliac artery if this is being preserved.

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When the leg device is in the target landing zone, the leg delivery system handle must be stabilised as the leg device is unsheathed Figures 12a, 12b & 12c.Note: The leg device remains attached to the delivery system until the release wire is removed Ensure the blue nose cone of the sheath slider is docked completely at the delivery handle

7 To fully release the leg device, pull the blue release clip and attached wire fully out of the delivery system handle The release wire should be pulled out distally, in line with the delivery system handle Figure 13.

8 Resheath and retract the leg delivery system carefully over the guidewire Ensure the guidewire is not removed with the delivery system Figure 14.

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Note: if the CLMW has been used, it must be exchanged for an ultrastiff 0035 guidewire before insertion of any haemo-static sheath or catheters on the contralateral side Re-insert the contralateral guiding catheter with the inner dilator in place and advance over the CLMW to the level of the tip of the Anaconda bifurcate body nose cone Remove inner dilator and the CLMW and exchange for a stiff 0035 guidewire Note: the magnet at the end of the CLMW is a larger diameter than the inner dilator therefore removal of the wire should take place from the proximal end of the dilator when removed from the arterial system

10 If required, insert an appropriate sized sheath to achieve haemostasis at the arterial access point

11 See Stage 4 if an iliac leg extension is required

Step Stage 4. Anaconda Iliac Leg or Flared/Tapered Iliac Leg Extension Introduction & Deployment

1 When working on the contralateral side, ensure the Anaconda bifurcate body is stabilised throughout Stage 4

2

Prepare the leg delivery system as indicated in the leg delivery system preparation Stage 3a CAUTION: The control collar on any of the leg delivery systems will be fixed and cannot be used to reposition the leg device. The leg delivery system handle must be stabilised whilst unsheathing to prevent shortening of device and redundant fabric, or the risk of thrombus developing. The release wire must not be removed before the device is fully unsheathed as this could result in breakage of the release wire.

3 Advance the leg delivery system over the ultrastiff 0035 guidewire

4

Visualise the radiopaque markers on the proximal and distal end of the leg extension Figure 15.Note:Flared/taperedlegdeviceshaveanadditionalradiopaquemarkerwhichidentifiesthetransitionzonebetweentheflared/taperedandstraightsegmentsof the iliac legdevice.See Anaconda Iliac Leg diagrams in Section 1 and Figure 16.

5

Considerperformingangiographytoconfirmthattheproximalanddistalmarkersofthelegextensiondeviceareinthetarget landing zone Figure 17. CAUTION: The transition marker on the leg extension device must not be positioned proximal to the distal marker of the leg device into which it is being docked. The flared/tapered segment of the extension should not be contained within the overlap zone. Figure 18. CAUTION: Do not retract the outer sheath until there is a minimum overlap of 20mm between the leg device and leg extension device. CAUTION: The distal radiopaque marker should be at least 5mm proximal to the internal iliac artery if this is being preserved.

14

6

When the leg device is in the target landing zone, the leg delivery system handle must be stabilised as the leg device is unsheathed Figure 19 & 20.Note: The leg device remains attached to the delivery system until the release wire is removed Ensure the sheath slider is retracted completely into the delivery system handle

7 To fully release the leg device, pull the blue release clip and attached wire fully out of the delivery system handle The release wire should be pulled out distally, in line with the delivery system handle Figure 13.

8 Re-sheath and retract the leg delivery system carefully over the guidewire Ensure the guidewire is not removed with the delivery system Figure 14.

9

Note: If the CLMW is still in situ, it must be exchanged for an ultrastiff 0035 guidewire before insertion of any haemo-static sheath or catheters Re-insert the contralateral guiding catheter with the inner dilator in place and advance over the CLMW to the level of the tip of the Anaconda bifurcate body nose cone This will minimise the risk of passing any wires through the bifurcate body control cord Remove inner dilator and the CLMW and exchange for a stiff 0035 guidewire Note: the magnet at the end of the CLMW is a larger diameter than the inner dilator therefore removal of the wire should take place from the proximal end of the dilator when removed from the arterial system

10 If required, insert an appropriate sized sheath to achieve haemostasis at the arterial access point

Step Stage 5. Deployment of the Anaconda Bifurcate Body

1Verify that the proximal ring stent of the Anaconda bifurcate body remains in the target landing zone and is positioned below the level of the renal arteries Consideringperformingangiographytoaidverification.

2If minor proximal or distal repositioning of the Anaconda bifurcate body is required, see Stage 1c, Step 9 Figure 21. CAUTION: Following any minor repositioning, ensure adequate overlap of bifurcate body/leg and leg/leg exten-sions is maintained.

3If repositioning was required, ensure the control collar is fully forward and the Anaconda bifurcate body is positioned in the target landing zone At this point the bifurcate body remains attached to the delivery system Figure 22.Consider performing angiography to verify the Anaconda bifurcate body is in the target landing zone

4 StabilisetheAnacondabifurcatebodydeliverysystemwhenthefinalpositionisconfirmed.

THE NEXT STEPS WILL FULLY DEPLOY THE BIFURCATE BODY AND NO FURTHER REPOSITIONING IS POSSIBLE

5Pull the white release clip and attached wire fully out of the delivery system handle CAUTION: This eliminates the ability to open and close the ring stent. The release wire should be pulled out distally, in line with the delivery system handle Figure 23.

6To fully deploy the Anaconda bifurcate body from its delivery system, pull the blue release clip and attached wire fully out of the delivery system handle This releases the Anaconda bifurcate body from its delivery system The release wire should be pulled out distally, in line with the delivery system handle Figure 24.

THE BIFURCATE BODY IS NOW FULLY DEPLOYED AND NO FURTHER REPOSITIONING IS POSSIBLE

7

Resheath and retract the Anaconda bifurcate body delivery system carefully over the guidewire Ensure the guidewire is not removed with the delivery system Figure 25.CAUTION: If any resistance is experienced during the removal of the Anaconda bifurcate body delivery sys-tem, stop the procedure immediately. An additional stage may be required for safe removal of the delivery system. Please see additional information in Section 3 Bailout Procedures Section 3.1.7.

8 Leave the ultrastiff guidewire in place for advancement of the ipsilateral iliac leg delivery system

Step Stage 6. Anaconda Ipsilateral Iliac Leg or Flared/Tapered Iliac Leg Introduction & Deployment

1

Prepare the leg delivery system as indicated in the leg delivery system preparation Stage 3a CAUTION: The control collar on any of the leg delivery systems will be fixed and cannot be used to reposition the leg device. The leg delivery system handle must be stabilised whilst unsheathing to prevent shortening of device and redundant fabric, increasing the risk of thrombus developing. The release wire must not be removed before the device is fully unsheathed as this could result in breakage of the release wire.

2 Advance the leg delivery system over the ipsilateral guidewire

3

Visualise the radiopaque docking markers on the Anaconda bifurcate body and the proximal marker of the leg device Figure 26.Flared/taperedlegshaveanadditionalradiopaquemarkerwhichidentifiesthetransitionzonebetweentheflared/taperedand straight segments of the leg device CAUTION: Do not retract the outer sheath until the position is satisfactory in relation to the Anaconda bi-furcate body docking markers, i.e. when the proximal marker of the leg device is 2-3mm above the proximal radiopaque docking marker of the Anaconda bifurcate body.

15

4

Considerperformingangiographytoconfirmthepositionof the legdevicedistalradiopaquemarker inrelationtothetarget landing zone CAUTION: The distal radiopaque marker should be at least 5mm proximal to the internal iliac artery if this is being preserved.

5When the leg device is in the target landing zone, the leg delivery system handle must be stabilised as the leg device is unsheathed The leg device remains attached to the delivery system until the release wire is removed Ensure the sheath slider is docked completely at the delivery handle Figure 27.

6 To fully release the leg device, pull the blue release clip and attached wire fully out of the delivery system handle The release wire should be pulled out distally, in line with the delivery system handle Figure 13.

7 Resheath and retract the leg delivery system carefully over the guidewire Ensure the guidewire is not removed with the delivery system Figure 14.

8 If required, insert an appropriate sized sheath to achieve haemostasis at the arterial access point

9 SeeStage4ifafurtheriliaclegorflared/taperediliaclegextensionisrequired.

Step Stage 7. Smoothing of the Anaconda Bifurcate Body Stent Graft Fabric and Smoothing & Modelling of the Iliac Legs

1It is recommended to smooth the stent graft fabric of the docking zone of the Anaconda bifurcate body by using an appropriate sized compliant or non-compliant balloon Note: Please refer to individual manufacturers guidelines for size selection, preparation, and use of all balloons

2It is also recommended to smooth and model the full length of the iliac legs and overlaps using an appropriate sized compliant or non-compliant balloon Note: Please refer to individual manufacturers guidelines for size selection, preparation, and use of all balloons

3 Ensureanyballoonsarecompletelydeflatedpriortoremovaltoavoidcatchingthestentgraftmaterial.

Step Stage 8. Completion Angiography and Verification of Stent Graft Placement and Seal

1

At the completion of the procedure perform angiography to assess the stent graft for proximal and distal endoleaks, and to verify position of the implanted stent graft in relation to the abdominal aortic aneurysm and renal arteries Figure 28.Note:Ifdeemedclinicallysignificant;leaksattheattachmentofconnectionsitesshouldbetreatedusinganappropriatesized compliant balloon to remodel the stent graft against the vessel wall Note:Clinicallysignificantendoleaks thatcannotbecorrectedbyballooningmaybe treatedbyaddingaorticor iliacextension components to the previously placed stent graft components CAUTION: Any endoleak left during the implantation procedure must be carefully monitored after implantation.

2 Remove all ancillary devices prior to repairing the entry site

3 Repair the entry site with standard closure techniques

4Regular follow-up including imaging of the Anaconda Stent Graft System should be performed in accordance with the standard of care of the treating hospital/clinician Patients should be monitored on a regular basis for aneurysm growth, occlusion of vessels within the treatment area, pulsatility, migration, endoleaks and device integrity

16

SEC

TIO

N 3

: BA

ILO

UT

PRO

CED

UR

ESIn

the

unlik

ely

even

t of d

eliv

ery

syst

em o

r dep

loym

ent i

ssue

s, th

e fo

llow

ing

bailo

ut te

chni

ques

may

be

used

It

is re

com

men

ded

that

bai

lout

pro

cedu

res

are

carr

ied

out i

n th

e pr

esen

ce o

f Vas

cute

k Lt

d tr

aine

d pe

rson

nel a

nd t

hat c

linic

ians

are

tra

ined

in th

ese

bailo

ut p

roce

dure

s by

Vas

cute

k Lt

d pe

rson

nel

Issu

eP

oten

tial P

robl

emP

roce

ss

3.1

Del

iver

y Sy

stem

Dep

loym

ent I

ssue

s

1. Difficultyinadvancing

the

bifu

rcat

e bo

dy

deliv

ery

syst

em

thro

ugh

acce

ss

vesselsordifficultyadvancing

the

iliac

leg

thr

ough

acc

ess

vess

els

or t

hrou

gh b

ifurc

ate

body

The

oute

r she

ath

of th

e de

liv-

ery

syst

em m

ay e

xten

d pa

st

the

wid

est p

ortio

n of

the

deliv

-er

y sy

stem

tip

expo

sing

a li

p of

pla

stic

Th

is m

ay i

mpe

de

the

adva

ncem

ent o

f the

del

iv-

ery

syst

em

1.

With

draw

the

deliv

ery

syst

em a

nd c

heck

if th

e ou

ter s

heat

h ha

s m

oved

bey

ond

the

wid

est p

ortio

n of

the

deliv

ery

syst

em

tip I

f thi

s is

not

the

case

re-a

dvan

ce th

e de

liver

y sy

stem

2.

If th

e ou

ter s

heat

h do

es e

xten

d be

yond

the

wid

est p

ortio

n of

the

deliv

ery

syst

em ti

p, s

low

ly re

tract

the

shea

th s

lider

unt

il th

e ou

ter s

heat

h is

in li

ne w

ith th

e w

ides

t por

tion

of th

e de

liver

y sy

stem

tip

3.

If th

e ou

ter s

heat

h ca

nnot

be

with

draw

n un

til it

is in

line

with

the

wid

est p

ortio

n of

the

deliv

ery

syst

em ti

p, re

plac

e w

ith

anot

her d

eliv

ery

syst

em

2.

The

tip/n

ose

cone

of

th

e co

ntra

late

ral i

liac

leg

deliv

ery

syst

em m

eets

res

ista

nce

and

will

not

adv

ance

bey

ond

the

leve

l of t

he b

ifurc

ate

body

ring

st

ents

The

tip o

f the

ilia

c le

g de

liver

y sy

stem

may

cat

ch o

n th

e bi

-fu

rcat

e bo

dy d

eliv

ery

syst

em

cont

rol

wire

s,

impe

ding

th

e m

ovem

ent

of

the

iliac

le

g de

liver

y sy

stem

thr

ough

the

bi

furc

ate

body

CA

UTI

ON

: Do

not f

orce

fully

adv

ance

the

iliac

del

iver

y sy

stem

.1

If u

sing

an

ultra

stiff

sta

inle

ss s

teel

gui

dew

ire to

adv

ance

the

iliac

leg

deliv

ery

syst

em, c

onsi

der e

xcha

ngin

g th

is g

uide

wire

fo

r a le

ss ri

gid

non-

mag

netic

ultr

astif

f gui

dew

ire (N

MU

S)

Alte

rnat

ivel

y:

1. Th

eiliaclegdeliverysystem

shouldbere

tracteduntilitstipisinlinewiththeflowsplitterofthebifurcatebody

2.

The

cont

rala

tera

l gui

dew

ire s

houl

d be

retra

cted

unt

il its

tip

is a

ligne

d w

ith th

e tip

of t

he il

iac

leg

deliv

ery

syst

em C

are

mus

t be

take

n to

mai

ntai

n co

ntra

late

ral g

uide

wire

acc

ess

of th

e bi

furc

ate

body

3.

The

cont

rala

tera

l gui

dew

ire s

houl

d be

re-a

dvan

ced,

follo

wed

by

the

iliac

leg

deliv

ery

syst

em, w

hich

sho

uld

now

adv

ance

un

impe

ded

3.

The

bifu

rcat

e bo

dy

deliv

ery

syst

em

kink

s as

it

is

intro

duce

d th

roug

h th

e ac

cess

ves

sels

, or

whe

n th

e bi

furc

ate

body

rin

g st

ent

is

clos

ed fo

r rep

ositi

onin

g

The

cent

ral c

ore

of th

e bi

fur-

cate

bo

dy

deliv

ery

syst

em

isflexibleandreliesonthe

stiff

ness

of

th

e gu

idew

ire

over

whi

ch it

is in

trodu

ced

for

rigid

ity

Use

an

alte

rnat

ive

ultra

stiff

gui

dew

ire to

intro

duce

the

bifu

rcat

e bo

dy d

eliv

ery

syst

em C

are

mus

t be

take

n to

ens

ure

that

no

kin

king

occ

urs

whe

n un

pack

ing

and

prep

arin

g th

e de

liver

y sy

stem

4.

The

deliv

ery

syst

em s

heat

h sl

ider

be

com

es

deta

ched

fro

m t

he o

uter

she

ath

whe

n de

ploy

ing

a bi

furc

ate

body

or

iliac

dev

ice

The

oute

r she

ath

fails

to w

ith-

draw

and

exp

ose

the

sten

t gr

aft

Visualizeviafluoroscopyifthestenthasbeenpartiallyunsheathed.Ifnounsheathinghasoccurredremovethedelivery

syst

em a

nd in

trodu

ce a

new

del

iver

y sy

stem

If

the

graf

t has

bee

n pa

rtial

ly u

nshe

athe

d th

e fo

llow

ing

stag

es w

ill fu

lly u

nshe

ath

the

graf

t:1.

R

etra

ct th

e sh

eath

slid

er u

ntil

its b

lue

tip is

fully

doc

ked

with

the

deliv

ery

syst

em h

andl

e2.

C

aref

ully

cut

a c

entra

l lin

e th

roug

h th

e ou

ter s

heat

h fro

m th

e ha

ndle

app

roxi

mat

ely

10 c

m lo

ng3.

A

ttach

one

set

of f

orce

ps to

eac

h si

de o

f the

she

ath

Ens

urin

g th

e de

liver

y sy

stem

han

dle

is s

tabi

lized

4. Retracttheoutersheathcarefullyunderfluoroscopyensuringthesheathissplitapartw

ellawayfrom

thevessel,and

that

the

shea

th is

spl

it ou

tsid

e th

e ar

terio

tom

y to

pre

vent

any

dam

age

to th

e na

tive

vess

el5.

Th

e sh

eath

sho

uld

be re

tract

ed u

ntil

its d

ista

l end

is in

line

with

the

blue

tip

of th

e fu

lly re

tract

ed s

heat

h sl

ider

Thi

s w

ill

ensu

re th

at th

e gr

aft i

s fu

lly u

nshe

athe

d C

AU

TIO

N: D

o no

t rem

ove

the

rele

ase

wire

s un

til th

e gr

aft i

s fu

lly u

nshe

athe

d.

17

5.

Follo

win

g re

tract

ion

of

the

bifu

rcat

e bo

dy

deliv

ery

syst

em s

heat

h, t

he b

ifurc

ate

body

rin

g st

ents

do

not

open

fu

lly i

n th

e ao

rtic

neck

Th

is

may

resu

lt in

une

xpec

ted

and

unw

ante

d m

ovem

ent

of t

he

bifu

rcat

e bo

dy

The

bifu

rcat

e bo

dy ri

ng s

tent

s fa

il to

ope

n fu

lly d

ue t

o th

e si

licon

e rin

g ab

ove

the

cont

rol

colla

r on

the

del

iver

y sy

stem

ha

ndle

bei

ng a

ltere

d fro

m it

s in

tend

ed p

ositi

on a

nd m

ain-

tain

ing

the

sten

t gra

ft in

a p

ar-

tially

col

laps

ed p

ositi

on

1.

Ens

ure

the

peak

of t

he to

p rin

g st

ent o

f the

bifu

rcat

e bo

dy is

pos

ition

ed b

elow

the

rena

l arte

ries

in th

e ta

rget

land

ing

zone

2.

Sta

bilis

e th

e bi

furc

ate

body

del

iver

y sy

stem

han

dle

3.

Cut

the

silic

one

ring

and

rem

ove

it fro

m th

e de

liver

y sy

stem

han

dle

CA

UTI

ON

: Ens

ure

that

the

cont

rol w

ires

in th

e gr

oove

ben

eath

the

silic

one

ring

are

not a

ccid

enta

lly c

ut.

4. Th

edeviceshouldbeobservedunderfluoroscopytoensuretheringstentsopenoutandengageintheaorticneck.

6.

The

bifu

rcat

e bo

dy ri

ng s

tent

s fa

il to

ope

n an

d cl

ose

whe

n at

tem

ptin

g to

rep

ositi

on t

he

devi

ce

S

napp

ed

deliv

ery

syst

em

cont

rol w

ires

Theringstentpositionmustbeconfirmedinrelationtotherenalarte

ries.

1.

If th

e po

sitio

n is

sat

isfa

ctor

y, th

en re

leas

e th

e gr

aft f

rom

the

deliv

ery

syst

em2.

If

the

posi

tion

is to

o lo

w th

en c

onsi

der u

sing

an

exte

nsio

n cu

ff or

exp

lant

3.

If th

e po

sitio

n is

too

high

and

rena

l arte

ries

are

occl

uded

, con

side

r exp

lant

ing

the

devi

ce

7.

Res

ista

nce

is m

et o

n re

mov

al

of

the

bifu

rcat

e

bo

dy

deliv

ery

sy

stem

f

ollo

win

g fu

ll de

ploy

men

t an

d re

leas

e of

the

bifu

rcat

e bo

dy d

evic

e

In e

xcep

tiona

l circ

umst

ance

s,

a co

ntra

late

ral

guid

ewire

, ca

thet

er a

nd/o

r ba

lloon

cou

ld

have

pas

sed

thro

ugh

a bi

-fu

rcat

e bo

dy c

ontro

l su

ture

s Th

is w

ill re

quire

thei

r rem

oval

pr

ior t

o re

-she

athi

ng o

f the

bi-

furc

ate

body

nos

econ

e as

il-

lust

rate

d in

the

follo

win

g te

xt

Figu

re 2

9a.

NO

TE: T

his

proc

edur

e m

ust b

e do

ne w

hils

t mai

ntai

ning

ipsi

late

ral g

uide

wire

acc

ess

thro

ugho

ut

1.

The

bifu

rcat

e bo

dy d

eliv

ery

syst

em s

houl

d be

adv

ance

d 10

mm

pro

xim

ally

2.

Slo

wly

re-s

heat

h an

d re

tract

the

deliv

ery

syst

em o

ver t

he g

uide

wire

3.

If re

sist

ance

is s

till e

xper

ienc

ed in

rem

ovin

g th

e bi

furc

ate

body

del

iver

y sy

stem

, sto

p im

med

iate

ly4.

A

ny c

ontra

late

ral g

uide

wire

, cat

hete

r and

/or b

allo

on m

ust b

e ca

refu

lly re

tract

ed u

ntil

thei

r tip

s ar

e w

ithin

the

iliac

leg

sten

t graftbutdistaltothecontralateralcannulationflareofthebifurcatebody.F

igur

e 29

b.

Follo

win

g th

is a

djun

ctiv

e pr

oced

ure,

it s

houl

d no

w b

e po

ssib

le to

rem

ove

the

bifu

rcat

e bo

dy d

eliv

ery

syst

em a

s no

rmal

Fi

gure

29c

. C

AU

TIO

N: E

nsur

e flu

oros

copi

c vi

sual

izat

ion

is m

aint

aine

d th

roug

hout

this

pro

cedu

re to

obs

erve

for a

ny m

ove-

men

t of t

he b

ifurc

ate

body

ste

nt g

raft.

8.

Exc

essi

ve

resi

stan

ce

is

enco

unte

red

whi

le

tryin

g to

re

tract

th

e sh

eath

sl

ider

on

a b

ifurc

ate

body

or

iliac

le

g de

liver

y sy

stem

or

th

e bi

furc

ate

body

/

iliac

le

g ca

nnot

be

unsh

eath

ed

The

oute

r sh

eath

of

th

e de

liver

y sy

stem

has

ki

nked

whi

le t

he d

eliv

ery

syst

em w

as b

eing

int

ro-

duce

d A

kin

k in

the

oute

r pl

astic

she

ath

at th

e le

vel

of t

he c

ompa

cted

dev

ice

may

m

ake

it ve

ry

dif-

ficult

tounsheaththe

devi

ce

NOTE

:Verifyonfluoroscopythatthecompacteddevicehasnotpartiallyunsheathed:

1.

Rem

ove

the

deliv

ery

syst

em a

nd re

plac

e w

ith a

new

del

iver

y sy

stem

2.

Take

car

e no

t to

kink

the

new

del

iver

y sy

stem

whi

le u

npac

king

and

pre

parin

g th

e sy

stem

3.

If a

NM

US

or C

LMW

gui

dew

ire is

bei

ng u

sed

to a

dvan

ce th

e de

liver

y sy

stem

, it m

ay b

e ad

visa

ble

to e

xcha

nge

this

for

an a

ltern

ativ

e ul

trast

iff o

r sup

er s

tiff g

uide

wire

C

AU

TIO

N: I

f the

dev

ice

has

part

ially

uns

heat

hed:

1.

Atte

mpt

to re

tract

the

shea

th s

lider

as

norm

al2.

If

the

she

ath

slid

er c

anno

t be

ret

ract

ed,

and

the

dev

ice

is p

artia

lly u

nshe

athe

d im

pedi

ng d

eplo

ymen

t or r

emov

al

thro

ugh

acce

ss p

oint

, con

side

r con

vers

ion

to o

pen

repa

ir to

exp

lant

the

sten

t gra

ft

9.

Whe

n pu

lling

the

rel

ease

rin

g an

d at

tach

ed w

ire t

o fu

lly

depl

oy

a bi

furc

ate

body

or

iliac

leg

dev

ice,

th

e re

leas

e w

ire b

reak

s,

or r

esis

tanc

e is

fel

t an

d th

e w

ire c

anno

t be

ful

ly

rem

oved

from

the

deliv

ery

syst

em h

andl

e

The

rele

ase

wire

m

ay

be

caug

ht

betw

een

the

shea

th s

lider

and

the

de-

liver

y sy

stem

han

dle

1.

Sta

bilis

e th

e de

liver

y sy

stem

han

dle

2.

Hol

d th

e bl

ue s

heat

h sl

ider

and

adv

ance

the

shea

th s

lider

by

a m

axim

um o

f 1 c

m T

his

will

ens

ure

that

the

rele

ase

wire

is

not

cau

ght b

etw

een

the

shea

th s

lider

and

the

deliv

ery

syst

em h

andl

e3.

If

the

rele

ase

wire

is in

tact

, atte

mpt

to p

ull i

t out

fully

of t

he d

eliv

ery

syst

em h

andl

e4.

If

the

rele

ase

wire

has

bro

ken,

use

ste

rile

forc

eps

to p

ull t

he re

leas

e w

ire o

ut fu

lly o

ut o

f the

del

iver

y sy

stem

han

dle

EN

D O

F D

ELI

VE

RY

SY

STE

M D

EP

LOY

ME

NT

ISS

UE

S

18

3.2

Ipsi

late

ral G

uide

wire

Issu

es

1.

Acc

iden

tal r

emov

al o

f th

e ip

sila

tera

l gui

dew

ire w

hen

rem

ovin

g th

e bi

furc

ate

body

del

iver

y sy

stem

Ipsi

late

ral

guid

ewire

acc

ess

is r

equi

red

to a

dvan

ce t

he

ipsi

late

ral

iliac

leg

deliv

ery

syst

em

into

th

e bi

furc

ate

body

As

the

ips

ilate

ral

sec-

tion

of t

he b

ifurc

ate

body

is

unsu

ppor

ted,

it

may

not

be

poss

ible

to

rein

sert

a gu

ide-

wire

usi

ng a

fre

esty

le

tech

-ni

que

A

Per

form

a c

ross

-ove

r pro

cedu

re fr

om th

e co

ntra

late

ral s

ide:

1.

Exc

hang

e th

e co

ntra

late

ral a

ngio

grap

hy c

athe

ter f

or a

sui

tabl

y sh

aped

gui

ding

cat

hete

r for

cro

ss- o

ver t

echn

ique

2.

Manipulatethecathetersothatitstippassesabovetheflow-splitterandentersthecontralaterallum

enofthebifurcate

body

3. Intro

duceasuitableflexibleguidew

ireandadvancedow

nthroughtheipsilaterallum

enofthebifurcatebody.

4.

Use

a s

nare

dev

ice

or fo

rcep

s to

gai

n co

ntro

l of t

he w

ire, o

n th

e ip

sila

tera

l sid

eC

AU

TIO

N: G

reat

car

e m

ust b

e ta

ken

to m

aint

ain

cont

rala

tera

l acc

ess

whi

le p

erfo

rmin

g th

is p

roce

dure

. Ens

ure

this

w

hole

pro

cedu

re is

car

ried

out u

nder

fluo

rosc

opy,

taki

ng c

are

that

the

bifu

rcat

e bo

dy is

not

dis

plac

ed.

OR

B U

se a

bra

chia

l app

roac

h to

pas

s a

suita

ble

guid

ewire

dow

n th

roug

h th

e ip

sila

tera

l lum

en o

f the

bifu

rcat

e bo

dy A

sna

re

devi

ce s

houl

d th

en b

e us

ed to

gai

n co

ntro

l of t

his

wire

on

the

ipsi

late

ral s

ide

CA

UTI

ON

: W

hen

ipsi

late

ral a

cces

s ha

s be

en a

chie

ved,

ens

ure

the

new

gui

dew

ire is

in t

he c

orre

ct lu

men

of

the

Ana

cond

a b

ifurc

ate

body

bef

ore

depl

oyin

g an

y ili

ac le

g in

to th

e do

ckin

g zo

ne.

3.3

Mag

net C

annu

latio

n Sy

stem

Issu

es

1.

The

mag

nets

con

nect

but

th

e m

agne

t gu

idew

ires

mee

t re

sist

ance

and

can

-no

t be

adv

ance

d th

roug

h th

e bi

furc

ate

body

The

mag

net

on

the

intri

n-si

c m

agne

t gu

idew

ire

may

ca

tch

on

an

a

na

tom

ica

l le

dg

e

or

cont

rol

sutu

res

insi

de t

he b

ifurc

ate

body

, im

-pe

ding

the

adva

ncem

ent o

f the

m

agne

t gui

de w

ires

thro

ugh

the

bifu

rcat

e bo

dy

1.

Man

ipul

ate

the

mag

net g

uide

wire

s so

that

the

mag

nets

dis

conn

ect a

s pe

r ins

truct

ion

in S

tage

2 S

tep

7 of

Sec

tion

2 D

e-pl

oym

ent P

roce

dure

Gen

tly ro

tate

the

intri

nsic

mag

net g

uide

wire

and

adv

ance

it in

depe

nden

tly o

f the

con

trala

tera

l mag

-ne

t gui

dew

ire, t

o en

sure

that

it c

an p

ass

thro

ugh

the

bifu

rcat

e bo

dy I

f the

intri

nsic

mag

net g

uide

wire

can

be

adva

nced

, reattachthemagnetsoutsideofthestentgraft,distaltothecontralateralcannulationflareandadvancebothguidew

ires

sim

ulta

neou

sly

If th

e m

agne

t gui

dew

ires

can

be p

artia

lly a

dvan

ced

thro

ugh

the

bifu

rcat

e bo

dy, i

t may

be

poss

ible

to

adva

nce

the

CLG

C, o

r sim

ilar c

athe

ter,

over

the

cont

rala

tera

l mag

net g

uide

wire

to a

chie

ve c

ontra

late

ral c

annu

latio

n2.

If

the

intri

nsic

mag

net g

uide

wire

can

not b

e ad

vanc

ed in

depe

nden

tly, o

r bo

th g

uide

wire

s st

ill c

anno

t be

adva

nced

si-

mul

tane

ousl

y, c

onsi

der

aban

doni

ng th

e m

agne

t sys

tem

and

per

form

ing

a fre

esty

le c

annu

latio

n of

the

bifu

rcat

e bo

dy

cont

rala

tera

l lum

en

CA

UTI

ON

: Due

to th

e un

supp

orte

d na

ture

of t

he A

naco

nda

bifu

rcat

e bo

dy, e

xtra

car

e m

ust b

e ta

ken

to v

erify

that

fr

eest

yle

cann

ulat

ion

has

been

suc

cess

ful.

CA

UTI

ON

: Whe

n co

ntra

late

ral a

cces

s ha

s be

en a

chie

ved,

ens

ure

the

new

gui

dew

ire is

in th

e co

rrec

t lum

en o

f the

A

naco

nda

bifu

rcat

e bo

dy b

efor

e de

ploy

ing

any

iliac

leg

into

the

dock

ing

zone

.

2.

The

mag

nets

co

nnec

t, bu

t re

peat

edly

se

para

te

whe

n ad

vanc

ing

mag

net

guid

ewire

s th

roug

h th

e bi

furc

ate

body

The

mag

net g

uide

wire

s ar

e no

t be

ing

adva

nced

sim

ulta

neou

sly

Or

Tortu

ous

acce

ss

vess

els

are

caus

ing

the

cont

rala

tera

l m

ag-

netguidewiretodeflectfromthe

intri

nsic

mag

net g

uide

wire

1.

One

ope

rato

r sho

uld

adva

nce

both

gui

dew

ires

sim

ulta

neou

sly,

with

one

han

d, to

redu

ce th

e ch

ance

of s

epar

atio

n2.

S

ome

slac

k sh

ould

be

intro

duce

d in

the

CLM

W o

r FC

LMW

bef

ore

adva

ncin

g th

e gu

idew

ires

sim

ulta

neou

sly

3.

If us

ing

the

CLM

W in

a p

atie

nt w

ith to

rtuou

s ac

cess

ves

sels

, thi

s sh

ould

be

exch

ange

d fo

r a F

CLM

W a

nd c

onne

ctio

n re

atte

mpt

ed

3.

The

cont

rala

tera

l lum

en o

f th

e bi

furc

ate

body

can

not

be c

annu

late

d us

ing

the

mag

net

syst

em,

as

the

mag

net o

n th

e in

trins

ic

mag

net

guid

ewire

do

es

not

mov

e as

ex

pect

ed

whe

n m

anip

ulat

ing

or a

d-va

ncin

g th

e in

trins

ic m

ag-

net g

uide

wire

The

seal

be

twee

n th

e in

-tri

nsic

m

agne

t gu

idew

ire

and

the

mag

net

mou

ldin

g lo

osen

s, c

ausi

ng th

e m

agne

t to

slid

e fre

ely

on th

e in

trins

ic

mag

net g

uide

wire

1.

If ca

nnul

atio

n of

the

cont

rala

tera

l lum

en o

f the

bifu

rcat

e bo

dy u

sing

the

mag

net s

yste

m is

uns

ucce

ssfu

l, ab

ando

n th

e m

agne

t sys

tem

2.

The

cont

rala

tera

l lim

b sh

ould

be

cann

ulat

ed u

sing

a fr

eest

yle

tech

niqu

e vi

a th

e co

ntra

late

ral a

cces

s ve

ssel

s, o

r by

a

brac

hial

app

roac

h as

per

Sec

tion

32

1b in

thes

e ba

ilout

pro

cedu

res

19

4.

Una

ble

to f

ully

with

draw

th

e in

trins

ic

mag

net

guid

ewire

so

th

at

the

floppytipoftheguidewire

is a

cros

s th

e co

ntra

late

ral

cann

ulat

ion

A hi

gh

forc

e m

ay

be

re-

quire

d to

lo

osen

th

e se

al

that

ho

lds

the

mag

net

mou

ldin

g in

pl

ace

on

the

intri

nsic

m

agne

t gu

idew

ire

This

sea

l m

ust

be l

oose

in

orde

r to

allo

w t

he m

agne

t m

ould

ing

to s

lide

alon

g th

e w

ire

1. Ifthemagnetm

ouldingsealisprovingdifficulttoloosenbyhand,w

ithdraw

theintrinsicmagnetguidewireasfaraspos-

sible,ensuringthemagnetm

ouldingisbelow

thecontralateralcannulationflare.D

eploythecontralateralleg.

2.

Whe

n re

mov

ing

the

bifu

rcat

e bo

dy d

eliv

ery

syst

em, o

bser

ve th

e co

ntra

late

ral l

eg w

here

it d

ocks

with

the

bifu

rcat

e bo

dy

to e

nsur

e th

e co

ntra

late

ral l

eg is

not

dis

plac

ed

Alwaysretra

cttheintrinsicmagnetguidew

ireunderfluoroscopy,stoppingwhenthefloppytipoftheintrinsicm

agnet

guidew

iresitsacrossthecontralateralcannulationflare.

5.

The

intri

nsic

m

agne

t

guid

ewire

ha

s a

ccid

en-

tally

no

t be

en

retra

cted

be

fore

dep

loyi

ng th

e co

n-tra

late

ral

iliac

le

g

The

mag

net

rem

ains

pro

xim

al

tothebifurcatebodyflow

sp

litte

r, re

sulti

ng

in

dif-

ficultyretra

cting

the

in-

trins

ic

mag

net

guid

ewire

/

bifu

rcat

e bo

dy d

eliv

ery

syst

em

The

mag

net

drag

s on

the

co

ntra

late

ral

iliac

leg

whe

n th

e in

trins

ic m

agne

t gu

ide-

wire

is re

tract

ed o

r the

bifu

r-ca

te b

ody

deliv

ery

syst

em is

re

mov

ed T

he fo

rce

requ

ired

to r

etra

ct t

he i

ntrin

sic

mag

-ne

t gu

idew

ire

/ bi

furc

ate

body

de

liver

y sy

stem

ca

n re

sult

in d

ista

l dis

plac

emen

t of

the

con

trala

tera

l ili

ac l

eg

or b

ifurc

ate

body

CA

UTI

ON

: Do

not u

se fo

rce

to w

ithdr

aw th

e in

trin

sic

mag

net

guid

e w

ire

or b

ifurc

ate

body

del

iver

y sy

stem

. U

sing

exc

essi

ve fo

rce

may

resu

lt in

the

cont

rala

tera

l ilia

c le

g or

bifu

rcat

e bo

dy b

eing

dis

plac

ed. I

f the

bifu

rcat

e bo

dy h

as n

ot b

een

fully

dep

loye

d, D

O N

OT

depl

oy a

t thi

s tim

eFi

rst,

atte

mpt

to re

tract

the

intri

nsic

mag

net g

uide

wire

whi

le c

aref

ully

obs

ervi

ng th

e co

ntra

late

ral i

liac

leg

/ bifu

rcat

e bo

dy I

f th

e w

ire c

anno

t be

retra

cted

unt

il th

e m

agne

t mou

ldin

g is

bel

ow th

e bi

furc

ate

body

, atte

mpt

the

follo

win

g:1.

R

emov

e th

e to

rque

dev

ice

from

the

dist

al e

nd o

f the

intri

nsic

mag

net g

uide

wire

2.

Fully

dep

loy

the

bifu

rcat

e bo

dy a

nd c

aref

ully

rem

ove

the

bifu

rcat

e bo

dy d

eliv

ery

syst

em (I

FU S

ectio

n 2,

Sta

ge 5

, Ste

p 6-

7), l

eavi

ng b

ehin

d th

e in

trins

ic m

agne

t gui

dew

ire a

nd m

agne

t mou

ld, a

s th

e de

liver

y sy

stem

is re

mov

ed3.

C

aref

ully

adv

ance

the

CLG

C o

r ot

her

suita

ble

8Fr

cath

eter

(pr

efer

ably

with

an

inne

r di

lato

r to

eas

e ad

vanc

emen

t of

the

cath

eter

) ove

r the

intri

nsic

mag

net g

uide

wire

Con

tinue

to a

dvan

ce th

e ca

thet

er u

ntil

the

tip o

f the

cat

hete

r pas

ses

betw

een

the

cont

rala

tera

l ilia

c le

g an

d th

e bi

furc

ate

body

Onc

e th

e tip

of t

he c

athe

ter

is a

t the

leve

l of t

he b

ifurc

ate

bodyflow

splitter,m

akingcontactw

iththemagnetm

ould,carefullyre

tracttheintrinsicmagnetguidewireandcatheter

sim

ulta

neou

sly

If S

tage

3 is

uns

ucce

ssfu

l in

retri

evin

g th

e in

trins

ic m

agne

t wire

and

mag

net m

ould

an

alte

rnat

ive

proc

edur

e ca

n be

util

ised

:1.

R

emov

e fro

m a

pro

xim

al a

ppro

ach

usin

g sn

arin

g te

chni

ques

20

TABLE DES MATIRES

CHAPITRE 1 MODE DEMPLOI11 Composants du systme dimplantation dendoprothse Anaconda12 Indications13 Contre-indications14 Mises en garde15 Conseils aux patients et effets indsirables16 Formation17 Prparation en vue de limplantation18 Tailles et slection dun systme dimplantation dendoprothse Anaconda19 Suivi des patients110 Scurit en matire dimagerie par rsonance magntique111 Mise au rebut112 Renvoi dun systme dimplantation dendoprothse Anaconda utilis 113 Directives gnrales relatives la prparation du systme dimplantation dendoprothse

Anaconda

CHAPITRE 2 INSTRUCTIONS POUR LE DPLOIEMENT tape 1a Prparation du systme de mise en place du corps bifurqu Anaconda

tape 1b Procdure du guide mtallique homolatraltape 1c Introduction et positionnement du systme de mise en place du corps bifurqu Anaconda

tape 2 Insertion de la lumire controlatrale du corps bifurqu Anaconda tape 3a Prparation du jambage iliaque ou du jambage iliaque vas/conique Anaconda

tape 3b Introduction et dploiement du jambage iliaque controlatral ou du jambage iliaque vas/ conique Anaconda

tape 4 Introduction et dploiement du jambage iliaque ou dune extension du jambage iliaque vas/conique Anaconda tape 5 Dploiement du corps bifurqu Anaconda tape 6 Introduction et dploiement du jambage iliaque homolatral ou du jambage iliaque vas/ conique Anaconda tape 7 Lissage de lendoprothse du corps bifurqu Anaconda et lissage et modlisations des jambages iliaques tape8. Angiographiedecontrlepourvrifierlamiseenplaceetltanchitdelendoprothse

CHAPITRE 3 PROCDURES DE SECOURS

CHAPITRE 4 SCHMAS DU DPLOIEMENT

CHAPITRE 5 EXPLICATION DES SYMBOLES DES TIQUETTES DU PRODUIT

21

CHAPITRE 1 : MODE DEMPLOILe prsent livret fournit des instructions relatives lutilisation standard des systmes de pose dendoprothse AnacondaTM et Anaconda ONE-LOK (par la suite les deux systmes sont dsigns par le terme systme dimplantation dendoprothse Anaconda).Ilenvademmepourlejambageiliaque,quipeutdsignerdesconfigurationsdroites,vasesouconiques.Pourde plus amples informations sur le choix de la taille, prire de se reporter au tableau des dimensions des systmes dimplantation dendoprothse Anaconda ou Anaconda ONE-LOK (inclus dans lemballage du systme) Pour la liste des vnements inattendus pouvant survenir au cours de la procdure de dploiement, veuillez consulter la section 3 de ce mode demploi : Procdures de secours

1.1 COMPOSANTS DU SYSTME DIMPLANTATION DENDOPROTHSE ANACONDA Corps bifurqu du systme dimplantation dendoprothse Anaconda Corps bifurqu du systme dimplantation dendoprothse Anaconda ONE-LOK Jambages iliaques Jambages iliaques vass Jambages iliaques coniques Coiffe dextension aortique (voir mode demploi)

Systme de mise en place du corps bifurqu Anaconda

1 Diamtre de la gaine2 Faisceau3 Marqueur radio-opaque4 Curseur bleu de la gaine5 Collet de contrle bleu6 Poigne7 Attaches de libration blanches et bleues (guides)8 Robinet darrt blanc

9 Orificederinageblanc10 Guide mtallique aimant intrinsque11 Dispositif de couple12 Robinet darrt bleu13 Orificedeguidebleu14 Longueur totale15 Longueur de la gaine16 Dispositif du corps comprim

Systme de mise en place du jambage iliaque Anaconda

1 Diamtre de la gaine2 Faisceau3 Marqueur radio-opaque4 Curseur bleu de la gaine5 Poigne6 Attaches de libration bleues (guide)

7 Orificederinageblanc8 Orificedeguidebleu9 Longueur totale10 Longueur de la gaine11 Dispositif de jambage iliaque comprim

COMPACTED ILIACLEG DEVICE

BLUE SHEATH SLIDER

HANDLE

BLUE RELEASE CLIP (WIRE)

WHITE FLUSHING PORT

BLUE GUIDEWIREPORT

SHEATHDIAMETER

SHEATH LENGTH

OVERALL LENGTH

NOSE CONE

RADIOPAQUEMARKER

12

3

4

5

6

7

8

9

10

11

NOSE CONE

COMPACTED BODYDEVICE

BLUE SHEATH SLIDER

BLUE CONTROL COLLARHANDLE

WHITE & BLUE RELEASECLIPS (WIRES)

WHITE FLUSHING PORT

BLUE GUIDEWIREPORT

SHEATHDIAMETER

SHEATH LENGTH

OVERALL LENGTH

RADIOPAQUEMARKER

TORQUE DEVICE

WHITE STOPCOCK

BLUE STOPCOCK

INTRINSIC MAGNETGUIDEWIRE

12

3 45

6

7

89 10

16

15

14

13

12

11

22

Systme de mise en place du jambage vas/conique Anaconda

1 Diamtre de la gaine2 Faisceau3 Marqueur radio-opaque4 Curseur bleu de la gaine5 Colletfixe6 Poigne

7 Attaches de libration bleues (guide)8 Orificederinageblanc9 Orificedeguidebleu10 Longueur totale11 Longueur de la gaine12 Dispositif de jambage iliaque comprim vas/conique

Corps bifurqu Anaconda (Illustration ONE-LOK)

1 Marqueurs radio-opaques controlatraux2 Crochet de crte3 Marqueurs radio-opaques dattachement du jambage4 vasement de la canulation controlatrale avec marqueurs radio-

opaques5 Marqueur radio-opaque distal

6 Diviseurduflux7 Anneau secondaire8 Crochet en forme de creux9 Anneau proximal