MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number	SB1601D
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: medical device sent to third partner for investigation (gepromed).W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
The following was reported to gore by gepromed: on (b)(6) 2016, a 51-year-old patient with some medical history, underwent a procedure where a gore-tex® stretch vascular graft was used as a aorto-bifemoral bypass in order to treat a peripheral artery disease, particularly claudication.On (b)(6) 2024, after approximately 8 years and 8 months, the distal part of the stretch vascular graft was explanted due to material alteration, particularly anastomotic rupture.
Additional Manufacturer Narrative
H6: codes added to include type of investigation, product history review: a review of the manufacturing records indicated the lots met all pre-release specifications.The prosthesis shape is no more tubular.The extremity a is not observable.The extremity b is also cutted.Anastomosis stitches are visible inside the prosthesis.A patency test could not be performed on the device as it is not tubular.It can be noted that there is no biological tissue inside the prosthesis.The macroscopic analysis of explant found macroscopic defect such as cuts in the membrane structure, may be due to the explanation conditions.Device status: the device was returned to gepromed for investigation.Submitted in formalin was a gore® stretch vascular graft ¿ bifurcated.The scope and results of the investigation were summarized, and a report was submitted to w.L.Gore & associates.An explant scientist at w.L.Gore & associates reviewed the report.Clinical history provided by gepromed: the device was implanted in a 51 year old man.His cardiovascular risk factors were hta and active smoker with pulmonary, copd comorbidity.The eptfe prosthesis was implanted on february 9th, 2016, as an aorto-bifemoral bypass in order to treat a peripheral artery disease, particularly claudication.On november 4th, 2024, after approximately 8 years and 8 months, the distal part of the eptfe prosthesis was explanted due to material alteration, particularly anastomotic rupture.Explant scientist observations: the graft fragment has been transected at both poles as well as a complete transection along the length of one wall of the device and approximately 80 percent of the length of the opposite wall.The ablumen was covered in thick tan brown tissue and the blue alignment marks on the device were faintly visible.The exposed lumen showed multiple passes of blue monofilament suture suggestive of an anastomotic site.The patency of the graft fragment could not be determined based on the condition of the graft fragment returned.Material disruptions (e.G., transections) were consistent with those caused by surgical instrumentation (e.G., scalpel, scissors) during the surgical procedure and explant process.Request for additional analysis: no reason: based on the explant scientist¿s review of the gepromed report and the condition of the graft fragment returned, no additional analysis is requested.

• Brand Name: GORE-TEX® STRETCH VASCULAR GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21025020
• Report Number: 2017233-2024-05671
• Device Sequence Number: 18418772
• Product Code: DSY
• UDI-Device Identifier: 00733132611829
• UDI-Public: 00733132611829
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K904282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2020
• Device Catalogue Number: SB1601D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 49 KG