P ST Mesh with E 2 Positioning System · en 14. Do not apply sharp, pointed, cautery devices, or...

P��™ ST Mesh with E�� 2™ Positioning SystemA Bioresorbable Hydrogel Coated Mesh with Positioning System for Laparoscopic Ventral Hernia Repair

INSTRUCTIONS FOR USE

OnlyResorbable(mesh)

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BAW3790500 R1.indd 1BAW3790500 R1.indd 1 1/10/2019 11:11:07 AM1/10/2019 11:11:07 AM

enPHASIX™ ST Mesh with ECHO 2™ Positioning SystemA Bioresorbable Hydrogel Coated Mesh with Positioning System for Laparoscopic Ventral Hernia Repair

INSTRUCTIONS FOR USE (IFU)

DEVICE DESCRIPTIONPHASIX™ ST Mesh with ECHO 2™ Positioning System (the device) is a low profi le, bioresorbable hydrogel coated mesh, with a preattached removable positioning system, designed for the reinforcement and reconstruction of soft tissue defi ciencies during laparoscopic ventral hernia repair.

Poly-4-hydroxybutyrate

ECHO 2™ Positioning System

Fascial Side

PGA

Bioresorbable Hydrogel Coating

Ventral SidePHASIX™ ST Mesh is co-knitted using poly-4-hydroxybutyrate (P4HB) and polyglycolic acid (PGA) fi bers. P4HB is produced from a naturally occurring monomer and is processed into monofi lament fi bers and then knitted into a surgical mesh. P4HB degrades through a process of hydrolysis and a hydrolytic enzymatic digestive process. It has been developed to reinforce areas where weakness exists while minimizing the variability of resorption rate (loss of mass) and strength to provide support throughout the expected healing period. Preclinical implantation studies indicate that resorption of the P4HB fi bers is minimal throughout the 12 week expected healing period and up to 26 weeks post implantation. Signifi cant degradation of the mesh fi bers observed in preclinical studies within 12 to 18 months, indicate loss in mechanical integrity and strength of the mesh. While fi ber segments were observed at 18 months, they continued to degrade1. PHASIX™ ST Mesh is coated on the PGA surface with a resorbable, chemically modifi ed sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows for a prompt fi broblastic response through the interstices of the mesh, allowing for complete tissue ingrowth, similar to P4HB mesh alone. The visceral side of the mesh is a resorbable hydrogel coating, separating the mesh from underlying tissues and organ surfaces to help minimize tissue attachment to the mesh. Shortly after hydration in saline, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days1. The ECHO 2™ Positioning System (the positioning system) facilitates deployment and positioning and is made of superelastic nitinol wire, encased in a nylon sleeve with a center hoisting suture (Fig. 1). The frame is preattached to PHASIX™ ST Mesh with nylon connectors. Once inserted into the abdomen, the positioning system facilitates both deployment and positioning of the mesh. After initial fi xation is complete, the ECHO 2™ Positioning System is removed from the body by cutting the center hoisting suture at the patient’s skin level and removing the positioning system from the mesh and directly out of the abdominal cavity through a trocar or skin incision. The ECHO 2™ Positioning System is designed to separate into one strand when removed (Fig. 2).Fig. 1

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8

9

10

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PHASIX™ ST MeshECHO 2™ Positioning System frameOuter long axis markersGreen removal indicator lineCenter struts (x4)Connector locations*BumperInner long axis markers<REMOVE> symbol (x2)Center hoisting suture*Consult table 2 for number of connectors per device size.

1

2

3

4

5

Fig. 2Center

hoisting suture

Connectors

Frame

Center struts (x4)

The sizes of the device that are packaged with an introducer tool are indicated in Table 1. The introducer tool is used to roll the device and facilitates laparoscopic deployment (see “Inserting with Introducer Tool” section). The mesh and positioning system are placed between the two tines of the introducer tool, and a T-cap secures the tines together (Fig. 3). Products without an introducer tool are designed to be deployed with a grasper (see “Inserting with Graspers” section).

Fig. 3 Mesh

T-cap

Tines

Positioning System

Trocar Size Recommendations Insert device into the abdomen through the recommended minimum trocar size or incision site. Never force the device through the trocar. If the device is not easily introduced down the trocar, remove the trocar and insert through the next largest available trocar size or incision site and reinsert trocar. See Table 1 for recommended minimum trocar size.

Table 1

REF Device Size DescriptionRecommended

Minimum Trocar Size*

Includes Introducer

Tool1210011 11 cm (4.5”) Circle 12 mm No1211015 10 cm x 15 cm (4” x 6”) Ellipse 12 mm No1210015 15 cm (6”) Circle 12 mm Yes1211520 15 cm x 20 cm (6” x 8”) Ellipse 12 mm Yes1211525 15 cm x 25 cm (6” x 10”) Oval 12 mm Yes1211823 18 cm x 23 cm (7” x 9”) Ellipse 12 mm Yes1210020 20 cm (8”) Circle 15 mm Yes1212025 20 cm x 25 cm (8” x 10”) Ellipse 15 mm Yes

1212533 25 cm x 33 cm (10” x 13”) Ellipse skin incision(12 mm trocar site) No

1213035 30 cm x 35 cm (12” x 14”) Ellipse skin incision(12 mm trocar site) No

* If the trocar has a proximal cap, removing it can help facilitate insertion of the device. Insertion forces may vary depending on rolled device size and graspers/trocar used.

INDICATIONS FOR USE1. PHASIX™ ST Mesh is indicated for use in the reinforcement of soft tissue, where

weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias.

2. The ECHO 2™ Positioning System is intended to facilitate the delivery and positioning of the mesh during laparoscopic hernia repair.

CONTRAINDICATIONSBecause PHASIX™ ST Mesh is fully resorbable, it should not be used in repairs where permanent wound or organ support from the mesh is required. WARNINGS1. Device manufacture involves exposure to tetracycline hydrochloride

and kanamycin sulfate. The safety and product use for patients with hypersensitivities to these antibiotics is unknown. Use of this device in patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided.

2. PHASIX™ ST Mesh is the only implantable component of the device. The ECHO 2™ Positioning System (which includes the frame, center hoisting suture and all connectors) must be removed from the patient and appropriately discarded.

3. Ensure proper orientation; the hydrogel coated side of the device should be oriented against the bowel or sensitive organs. Do not place the uncoated mesh side against the bowel. There is a risk for adhesion formation or erosions when the uncoated mesh side is placed in direct contact with the bowel or viscera. (Reference Surface Orientation section.)

4. Deviation from recommended instructions and/or procedural steps within this IFU may result in disruption or delamination of the hydrogel barrier of the mesh. Hydrogel disruption or delamination may cause an unexpected increase in adhesion formation in the area where it is disrupted.

5. The safety and effectiveness of PHASIX™ ST Mesh in bridging repairs has not been evaluated or established.

6. The use of any synthetic mesh or patch in a contaminated or infected wound could lead to fi stula formation and/or extrusion of the mesh and it is not recommended.

7. If an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the mesh.

8. To prevent recurrences when repairing hernias, PHASIX™ ST Mesh must be large enough to provide suffi cient overlap beyond the margins of the repair/primary closure. Careful attention to mesh fi xation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue.

9. The safety and effectiveness of PHASIX™ ST Mesh in the following applications has not been evaluated or established:

a. Pregnant women b. Pediatric use c. Neural and Cardiovascular tissue10. The device should be used once exterior foil pouch has been opened. Do

not store for later use. 11. Unused portions of the device should be discarded. If unused mesh

has been in contact with instruments or supplies used on a patient or contaminated with body fl uids, discard mesh with care to prevent risk of transmission of viral and other infections.

12. This device is provided sterile and has been designed for single use only. Reuse, resterilization, reprocessing and/or repackaging of any portion of the device may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient.

13. Reuse, reprocessing, resterilization, or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient or end user.

1 Preclinical data on fi le at C. R. Bard, Inc. results may not correlate to performance in humans.


en14. Do not apply sharp, pointed, cautery devices, or ultrasonic tools (such

as scissors, needles, tackers, diathermic tools, etc.) to the ECHO 2™ Positioning System frame.

15. The device contains superelastic nitinol wire; do not cut and avoid direct contact/coupling with active surgical electrodes.

16. The ECHO 2™ Positioning System should not be used with any other hernia device aside from those with which it comes preattached/packaged.

17. Discard the ECHO 2™ Positioning System (including the frame, center hoisting suture, all connectors) and introducer tool after use. These may be a potential biohazard. Handle and dispose in accordance with accepted medical practice and applicable local, state and federal laws and regulations.

18. Prior to use, carefully examine package and product to verify neither is damaged and that all seals are intact. Do not use if the foil pouch or package is damaged or open, or if the center of the temperature indicator on the foil pouch is black.

PRECAUTIONS1. Please read all instructions prior to use.2. Only physicians qualifi ed in the appropriate surgical techniques should use this

device. Users should be familiar with strength and mesh size requirements. Improper selection, placement, positioning and fi xation of the mesh can cause subsequent undesirable results.

3. The safety and effectiveness of the mesh has not been evaluated in the presence of malignancies in the abdominopelvic cavity.

4. Do not trim the PHASIX™ ST Mesh. This will affect the interface between the mesh and the positioning system.

5. Visualization must be maintained throughout the course of the entire surgical procedure. Additionally, laparoscopic removal of the ECHO 2™ Positioning System frame must be performed under suffi cient visualization of the entire device and surrounding anatomy, to ensure proper removal.

ADVERSE REACTIONSIn preclinical testing, PHASIX™ ST Mesh elicited a minimal tissue reaction characteristic of foreign body response to a substance. The tissue reaction resolved as the mesh was resorbed. Possible complications may include, but are not limited to, seroma, adhesion, hematoma, pain, infection, infl ammation, allergic reaction, hemorrhage, extrusion, erosion, migration, fi stula formation and recurrence of the hernia or soft tissue defect.

INSTRUCTIONS FOR USE Note on Transfascial Sutures: The ECHO 2™ Positioning System eliminates the need for transfascial orientation and positioning sutures. If transfascial sutures are used for fi xation, place the sutures after removing the positioning system from the body and after completing all other fi xation.Note on Surface Orientation: It is extremely important that this product is oriented correctly to function as intended. The bioresorbable coated side of the PHASIX™ ST Mesh (which contains the ECHO 2™ positioning system) must always be positioned towards those surfaces where minimal tissue attachment is desired, i.e., bowel or other visceral structures. The bioresorbable coated surface is designed to temporarily separate tissue surfaces and minimize tissue attachment to the mesh. The uncoated P4HB mesh side must face the surface where tissue ingrowth is desired, and must never be placed against the bowel or other visceral structures.Hydration1. Remove the device from the sterile pouch and hydrate

the device for no more than 1-3 seconds, in a sterile saline solution (Fig. 4).

2. PHASIX™ ST Mesh with ECHO 2™ Positioning System must be rolled immediately after hydration to maximize the fl exibility of the mesh.

Fig. 4

Fig. 5 bumper

Note: The safety and effectiveness of the device in combination with solutions other than sterile saline has not been tested.

Inserting with GraspersNote: This section is only applicable to REF 1210011, REF 1211015, REF 1212533 and REF 1213035, which do not include the introducer tool.1. Lay the device with positioning system side up, on a fl at, sterile surface, as

shown, with the long-axis pointing left to right, indicated by the black arrows in the middle and outer edges of the frame.

2. Start at the bottom (away from the bumper) and roll the device tightly along the long axis with the P4HB mesh side on the outside, and the hydrogel barrier and positioning system on the inside (Fig. 5). When rolling is complete, hold the rolled mesh tightly to keep it from unfurling. Ensure not to let the center hoisting suture become entangled with the device.

3. Hold the tightly-rolled device and fi rmly grasp the leading edge with an atraumatic grasper or equivalent tool. Take care to grasp both the mesh and positioning system at approximately a 45 degree angle (Fig. 6).

4. Firmly clamp the device with the grasper and insert the leading edge of the rolled device into the trocar or incision site. Do not let the rolled device bend as it is inserted into the trocar. In one continuous movement, deploy the device into the abdomen. Maintain visualization of the device via laparoscope, as it is deployed into the abdomen.Note: If the grasper slips from the device before it is completely deployed through the trocar or incision site, use a grasper from an opposing trocar location to pull the device into the abdomen. Ensure that the barrier is not damaged during insertion.

Fig. 6

Inserting with the Introducer ToolNote: This section is only applicable to REF 1210015, REF 1211520, REF 1211525, REF 1211823, REF 1210020 and REF 1212025, which include the introducer tool.

Fig. 7 bumper

Fig. 12

Fig. 8

Fig. 17

Fig. 13

Fig. 16

Fig. 18

1. Lay the device frame side up, on a fl at, sterile surface. Place the device between the tines of the introducer tool, parallel to the long axis. Ensure the tines are positioned over both the mesh and positioning system (opposite the bumper) as shown in Fig. 7. To secure the tines together, place the white T-cap on the distal end of the introducer tool (Fig. 7).

2. Begin rolling by rotating the handle of the introducer tool towards the center of the mesh (Fig. 8). Ensure not to let the center hoisting suture become entangled with the device. Place opposing hand under the mesh for support to aid in rolling (Fig. 9). Continue rolling until the entire device is wrapped around the introducer tool.

3. While holding the rolled mesh, remove the white T-cap from the end of the introducer tool and take care not to let the mesh unroll (Fig.10).

Fig. 9

Fig. 10

Fig. 11

Fig. 14

Fig. 15

4. Insert the distal end of the introducer tool into the trocar, while simultaneously rotating the handle of the introducer tool in the direction that the device was rolled (Fig. 11), and deliver the device through the trocar. Rotating the introducer tool in the direction the mesh was rolled will help keep it secure and facilitate insertion. Continue inserting until the handle of the introducer tool is near the cap of the trocar (Fig. 12). The mesh may not be completely in the abdomen at this point. Note: Deliver the device through the trocar under suffi cient visualization of the device and the surroundinganatomy.

5. When the handle reaches the cap of the trocar, rotate the handle ½ turn in the opposite direction from which it was rolled to loosen the grasp on the mesh (Fig. 12), and gently retract the introducer tool approximately 15 cm (6 inches) from the cap of the trocar (Fig. 13).

6. To continue insertion, retighten the mesh by rotating the handle in the original direction it was rolled (Fig. 8), then advance the handle to further introduce the mesh through the trocar. Do not completely remove the tines from the device until it has passed through the trocar entirely and the device is within the abdomen.

This repositioning of the insertion tool may be repeated as needed to complete the insertion into the abdomen.Note: Insert and deploy the device through the trocar under suffi cient visualization of the device and the surrounding anatomy. Note: If the introducer tool is removed from the device before it is completely deployed through the trocar, use an atraumatic grasper or equivalent tool to push the mesh through the trocar, or pull the device into the abdomen from an opposing trocar location.

7. After the mesh is deployed into the abdomen, remove and appropriately discard the introducer tool.

Hoisting, Positioning, and Fixation 1. Once the device is deployed into the abdomen, locate

the center hoisting suture. With a suture passer, retrieve the hoisting suture through the center of the hernia defect (Fig. 15). Avoid going through the umbilicus. To prevent potential contamination, ensure the suture does not slip back into the abdominal cavity.

2. Raise the center hoisting suture to hoist the device to the desired position, and then place an atraumatic clamp or hemostat on the center hoisting suture at the level of the skin to temporarily hold the device in place (Fig. 16).

3. Use the visual markings on the frame (Fig. 1) to identify the long and short axes of the mesh. Intraabdominally, use an atraumatic grasper to orient and position the device appropriately, in relation to the defect.

4. Once properly positioned, ensure that no bowel or any other tissue is entrapped between the device and the abdominal wall. Fixate around the entire perimeter of the mesh with fasteners placed 1-2 cm apart (Fig. 17). Ensure that no fasteners are placed through the frame.

Removal of ECHO 2™ Positioning System 1. Remove the atraumatic clamp or hemostat from

the center hoisting suture. Cut the center hoisting suture close to the patient’s skin, external to the patient (Fig. 18).

Caution: The clamp or hemostat must be removed from the center hoisting suture prior to positioning system removal.


en

Fig. 20

Fig. 21

2. For positioning system removal, grasp the perimeter of the positioning system indicated by the <REMOVE> symbol or anywhere along the green removal indicator line on the frame (Fig. 19). Removing from any other location is not recommended.

Begin pulling the positioning system off the mesh in one smooth motion. The connectors that attach the frame to the mesh will detach one-by-one from the mesh. Maintain constant visualization and ensure no tissue or organs are caught while removing the frame through the trocar.

Fig. 19

Note: Do not remove the positioning system from the center struts. Remove from the indicated <REMOVE>symbol or along the green indicator line.Note: The positioning system is designed to separate into one strand to facilitate removal (Fig. 20). It is recommended that the positioning system is removed from the same size trocar from which it was inserted.

3. Continue to remove the positioning system by pulling it through the trocar and out of the abdomen (Fig. 21).

4. Caution: Verify that the ECHO 2™ Positioning System is fully intact after removal, including all components listed in Table 2 and Fig. 22, and discard appropriately.

Table 2

REF Device Size Number of Connectors

CenterHoisting Suture

Positioning System Frame

Center Struts

1210011 11 cm (4.5”) 5 1 1 41211015 10 cm x 15 cm (4” x 6”) 5 1 1 41210015 15 cm (6”) 9 1 1 41211520 15 cm x 20 cm (6” x 8”) 9 1 1 41211525 15 cm x 25 cm (6” x 10”) 9 1 1 41211823 18 cm x 23 cm (7” x 9”) 9 1 1 41210020 20 cm (8”) 9 1 1 41212025 20 cm x 25 cm (8” x 10”) 7 1 1 41212533 25 cm x 33 cm (10” x 13”) 8 1 1 41213035 30 cm x 35 cm (12” x 14”) 8 1 1 4

Fig. 22Center hoisting

suture

Connectors

PositioningSystem Frame

Center struts (x4)

5. For fi nal fi xation of the mesh, place any additional fi xation as needed and complete the procedure. Care should be taken to ensure that the mesh is adequately fi xated to the abdominal wall. If necessary, additional fasteners and/or sutures should be placed. Follow established surgical principles.

FIXATIONBARD® fi xation devices or monofi lament sutures are recommended to properly secure the PHASIX™ ST Mesh. If other fi xation devices are used, they must be indicated for use in hernia repair. If transfascial sutures are used for fi xation, place sutures after removing the ECHO 2™ Positioning System from the body and after completing all mechanical fi xation. Care should be taken to ensure that the mesh is adequately fi xated to the abdominal wall.STORAGEStore at room temperature (not to exceed 30°C). Avoid prolonged exposure to elevated temperatures. If the center of the temperature indicator on the box is black, check the temperature indicator on the foil pouch. If the center of the temperature indicator on the foil pouch is black, do not use the product.TRACEABILITYA traceability label which identifi es the type, size, expiration date, and lot number of the device is attached to every package. This label should be affi xed to the patient’s permanent medical record to clearly identify the device which was implanted. If you experience a product failure, please contact Davol Inc. at 1-800-556-6275 for instructions on returning the product.RADIOPAQUENon-clinical testing performed in accordance with ASTM F640-12, section 6.3.1 demonstrated the frame of the ECHO 2™ Positioning System is visible through the body mimic.Bard, Davol, Echo 2, and Phasix are trademarks and/or registered trademarks of C. R. Bard, Inc. Copyright © 2018 C. R. Bard, Inc. All Rights Reserved.

SYMBOL DEFINITIONS

Removable Positioning System Catalogue number

Introducer Tool Use-by date

ECHO 2™ Positioning System frame

30°C86°F Upper limit of temperature

Center struts LOT Lot number

Connectors Circle

Center hoisting suture Ellipse

Remove component Oval

Actual size Caution

Resorbable (mesh) Contents

Single use Do not resterilize

Sterilized using ethylene oxide Consult instructions for use

Manufacturer Peel here

Do not use if package is damaged Biological risk

Do not use if the center of the temperature indicator is black. Only

U. S. Federal law restricts this device to sale by or on the order of a physician


PK3790364REV. 2018/12

Davol Inc.Subsidiary of C. R. Bard, Inc.100 Crossings BoulevardWarwick, RI 02886 USA1-401-825-83001-800-556-6275

Medical Services & SupportClinical Information Line1-800-562-0027


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