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

Catalog Number SRRT06060080L

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

Patient Problems Ischemia (1942); Insufficient Information (4580)

Event Date 06/05/2023

Event Type  Injury  

Manufacturer Narrative

H6-b13: additional information to the event, the occlusion/thrombosis, and the amputation have been requested from the physician.The answers are captured in section b5.H6-b15 and b17 and h3-other: the physician has sent the explanted device to an independent 3rd party for evaluation.Investigation (macroscopic and microscopic analysis of the explanted vascular graft after cleaning) was performed by the third party.The explanted device was not returned to gore for evaluation.Instead, they provided analysis results to gore, which are being reviewed by gore explant scientists.H6-b14 and c19: a review of the manufacturing records indicated the lots met all pre-release specifications.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 Description

It was reported to gore that the patient presented with a critical limb threatening ischemia due to an occlusion of the left superficial femoral artery has been treated with a gore-tex® stretch vascular graft on (b)(6) 2023.Three days later, reportedly in view of the depth and extent of the wounds and due to the very high risk of a rapid adverse and life-threatening outcome, the graft was explanted during a major amputation on (b)(6) 2023.

Manufacturer Narrative

Cause investigation and conclusion the physician has sent the explanted devices to an independent 3rd party for evaluation.The 3rd party provided gore with their macroscopic analysis results of the explanted devices.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.Additional information to further clarify the event and patient condition were requested from the 3rd party.Provided information were captured in the event description.A review of the manufacturing records indicated the lots met all pre-release specifications.No potential causes attributable to the manufacture of the device could be found.The analysis results provided by the 3rd party were reviewed by gore explant scientists.The graft fragment was reported to measure 140 mm in length with both ends transected, with a jagged-edged transection present at extremity b.Blue monofilament was present at extremity b, and blue alignment marks were visible throughout the graft.The abluminal surface of the graft was covered with minimal, scattered plaques of red brown material.The main body of the fragment towards extremity b appeared to have an area of dark red biologic material encapsulating the device fragment on the abluminal surface.The abluminal surface at extremity b was also encapsulated with light tan to dark red biologic material.At extremity a, there was a cut where a graft ring was damaged.The visible portion of the lumen at extremity a was occupied with light tan to dark red tissue, and the visible portion of the lumen at extremity b contained minimal scant plaques of red-brown biologic material.The patency of the graft fragment could not be confirmed based on the analysis or images provided.From gross images all material disruptions (i.E., material transections/cuts), appeared to be consistent with cutting by sharp surgical instruments (i.E., scalpel or scissors), likely used during surgical procedures.The evaluation based on the 3rd party report found no anomalies attributable to the manufacture of the device.Based on the 3rd party report and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.The review of the provided 3rd party explant report, the manufacturing records, and the available information reported in the complaint does not reasonably suggest a potential malfunction.It was reported to gore that the patient presented with critical limb threatening ischemia due to an occlusion of the left superficial femoral artery.Reportedly an attempt to save the leg with the gore graft bypass was made, but it was too late to help and amputation was due to non-graft factors.The ischemia requiring amputation was pre-existing, furthermore it was reported that the amputation was not associated with occlusion/thrombosis of the graft reasonably suggesting that amputation due to ischemia was related to patient condition which existed before the implantation of the graft.This event no longer meets the criteria of a reportable event and therefore it is was retracted.

Event Description

It was reported to gore that the patient presented with a critical limb threatening ischemia due to an occlusion of the left superficial femoral artery has been treated with a gore-tex® stretch vascular graft on (b)(6) 2023.Reportedly in view of the depth and extent of the wounds and due to the very high risk of a rapid adverse and life-threatening outcome the graft was explanted during a major amputation on (b)(6) 2023.Furthermore it was reported that the amputation was not associated with occlusion/thrombosis of the graft.

• Brand Name: GORE-TEX® STRETCH VASCULAR GRAFT
• Type of Device: 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17628924
• MDR Text Key: 322022661
• Report Number: 2017233-2023-04234
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132612383
• UDI-Public: 00733132612383
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K933943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SRRT06060080L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• 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; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male