MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® PROPATEN® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number HAX01A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seroma (2069)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Code 3221: device lot/serial number has been requested multiple times.As of today, no information has been received.No explanted vascular graft has been returned.As a result, direct product analysis cannot be conducted at this time.Patient information (age/dob; weight; gender; relevant medical history) were requested.As of today, no information has been received by gore.Instructions for use for: gore® propaten® vascular graft in possible complications with the use of any vascular prosthesis states: complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: redundancy; infection; ultrafiltration or perigraft seroma; thrombosis; mechanical disruption or tearing of the suture line, graft, and / or host vessel; excessive suture hole bleeding; formation of pseudoaneurysms due to excessive, localized, or large needle punctures; or perigraft hematomas.

Event Description

The following was reported to gore on (b)(6) 2021: on an unknown date, a patient was implanted with a gore vascular graft, possibly a gore® propaten® vascular graft (ax-bi-fem).About two months ago, the patient presented with seroma and the perigraft fluid accumulation was drained.As reported, blood was not evident in the seroma and the physician stated the drainage was not from the vascular graft.The graft was patent and was performing as intended.On (b)(6) 2021, the physician stated the seroma needs to be drained again.The physician plans to explant a portion of the vascular graft.The explant date has not been set at this time.

Event Description

The following was reported to gore: on (b)(6) 2020, a patient was implanted with a gore® propaten® vascular graft (vascular graft) during an axillary bifemoral procedure.On (b)(6) 2021, the patient presented with seroma and the perigraft fluid accumulation was drained on (b)(6) 2021.As reported, blood was not evident in the seroma and the physician stated the drainage was not due to the vascular graft.The vascular graft was patent and performing as intended.On (b)(6) 2021, the physician stated the seroma needs to be drained again as fluid accumulation was observed.On (b)(6) 2021, the vascular graft was explanted.As reported, patient had doppler signal in both legs and the graft was patent.

Manufacturer Narrative

H6 - code 213: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code 3233: a section of the explant vascular graft was returned for explant evaluation.Conclusion is not yet available.B3 - date of event updated to (b)(6) 2021.

Manufacturer Narrative

The device fragment was returned to w.L.Gore & associates for investigation.Submitted unfixed was a gore propaten (standard wall removable rings ax-bifem) vascular graft fragment (vgf).Vgf had been transected at both extremities, prior to arrival at w.L.Gore & associates.The abluminal surface was generally devoid of tissue, except for firmly adhered plaques of light tan/white tissue, near both extremities.The lumen was not patent and occluded with friable dark red/brown tissue; grossly interpreted as sedimented blood.Vgf was not properly stored in a fixative solution for proper preservation of the tissue, on and within the device fragment.Therefore, a histopathological examination of the tissue could not be performed, due to the lack of proper fixation prior to arrival at w.L.Gore & associates.Vgf was subjected to an enzymatic digestion process to remove biologic debris.Following digestion vgf was examined for material disruptions with the aid of a stereomicroscope.Disruptions identified were not associated with a handling or manufacturing process at w.L.Gore & associates.The disruptions identified were consistent with those caused by interaction with surgical instruments, likely used during a surgical procedure.

Manufacturer Narrative

D8/d9 - device returned : yes; date device returned to manufacturer.H5 - device manufacture date.

Event Description

The following was reported to gore: on (b)(6) 2020, a patient was implanted with a gore® propaten® vascular graft (ax-bi-fem).On (b)(6) 2021, the patient presented with seroma and the perigraft fluid accumulation was drained on (b)(6) 2021.As reported, blood was not evident in the seroma and the physician stated at the time the drainage was not from the vascular graft.The graft was patent and performing as intended.On (b)(6) 2021, the physician stated the seroma needs to be drained again.Doppler signals were evident in both legs and the graft was patent.Operative note state: the patient underwent left axillobifemoral bypass grafting for severe arterial insufficiency of the lower extremities months earlier.Patient developed a left chest and flank seroma, which has been operatively drained, and percutaneously drained in the office.The seroma has been recurrent and refractory to nonoperative management.The patient has pain, swelling, and discomfort continuously.It was concluded the bypass graft is likely overly porous and seroma will not resolve unless the graft is removed.On (b)(6) 2021, the left costal margin mid axillary line incision was opened and a large seroma capsule was immediately entered.About 700 ml of straw-colored clear fluid was drained and culture specimen was taken.The propaten® vascular graft was freely floating in the fluid.Previous axillary incision was reopened, and the origin of the graft was found to be well incorporated.Seroma was to that level and it was also drained.The previous left groin incision was opened.After clamping the axillary femoral limb just off the axillary takeoff, doppler signals in the foot was checked.Graft was manually occluded for several minutes.Doppler signals were easily audible, and feet were pink.There was adequate perfusion to avoid proceeding with redo revascularization.Consequently, the graft was transected proximally.The stump of the axillary artery was oversewn with 5-0 prolene suture.The vascular graft was removed from the tunnel.The crossover limb origin in the groin was also transected and oversewn with 5-0 prolene in two layers.After removing the capsule, irrigation was done and good hemostasis was noted.The groin and axillary wounds were closed.The costal margin wound was packed and a wound vac sponges traveling superiorly and inferiorly through the wound were placed through the wound.This was attached to suction; good seal and good vacuum were noted.The patient tolerated the procedure well.

Manufacturer Narrative

A gore® propaten® vascular graft (standard wall removable rings ax-bifem) was implanted to treat peripheral arterial disease (pad) on (b)(6) 2020.Device fragments were returned on two separate dates: (b)(6) 2021 (vgf-1) and (b)(6) 2021 (vgf-2).An explant evaluation was performed for each fragment returned.Vgf-1: see supplemental manufacturing report #2 for results.Vgf-2: submitted unfixed was a gore propaten (standard wall removable rings ax-bifem) vascular graft fragment (vgf-2).The fragment had been transected at both extremities, prior to arrival at w.L.Gore & associates.The luminal and abluminal surfaces of vgf-2 were generally devoid of tissue.The lumen of vgf-2 was widely patent.The fragment was not properly stored in a fixative solution for proper preservation of the tissue, on and within the device fragment.Therefore, a histopathological examination of the tissue could not be performed, due to the lack of proper fixation prior to arrival at w.L.Gore & associates.The fragment was subjected to an enzymatic digestion process to remove biologic debris.Following digestion, the fragment was examined for material disruptions with the aid of a stereomicroscope.Disruptions identified were not associated with a handling or manufacturing process at w.L.Gore & associates.The disruptions identified were consistent with those caused by interaction with surgical instruments, likely used during a surgical procedure.A1 - patient id was entered.

• Brand Name: GORE® PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11690864
• MDR Text Key: 249105772
• Report Number: 2017233-2021-01871
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K901641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2023
• Device Model Number: HAX01A
• Device Catalogue Number: HAX01A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male