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

Model Number RRT06060080L

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Ischemia (1942)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: other code - the medical device returned to a third party for investigation.The analysis report was shared with gore and evaluated appropriately.The investigation is still ongoing.The results will be included in the final report.

Event Description

It was reported to gore that patient underwent endovascular treatment on (b)(6) 2019 for a femoro-anterio-tibial bypass (extra-anatomic) in order to treat a highly advanced right limb critical ischemia, with superinfected major trophic disorders, by using a gore-tex® vascular graft - thin-walled removable ringed.It was stated that the bypass thrombosed rapidly and in front of the very important trophic disorders (painful and superinfected) and despite revascularization, it was decided to perform a thigh amputation three days later.Reportedly, the prosthesis was sent for analysis.

Manufacturer Narrative

H6 evaluation codes investigation findings 213 refers to the phr-review.Phr-review: a review of the manufacturing records indicated the lot met all pre-release specifications.A review of the boxing records indicated the lot met all pre-release specifications.Explant investigation (ei): the following is a summary of the ei observations: tissue present: no.The device fragment was generally devoid of tissue, except for an area of dark brown and tan tissue present on the abluminal surface, near extremity a.A small-bore fragment of the native vessel was attached to extremity a via blue sutures (presumptive anastomotic site).The lumen at extremity a was unobservable with the images provided.The luminal view from extremity b was partially obstructed with white/tan tissue.Lumen patency could not be determined with the images provided.A smooth-edge, partial, transverse transection was present on the graft fragment, near extremity b.Extremity b was transected, ovular in shape, and presented with smooth edges.The transections were consistent with those caused by sharp surgical instrumentation (i.E., scalpel, scissors), likely used during a surgical procedure.Request for additional analysis: no.Reason: material disruptions are consistent with those caused by surgical instrumentation during the explant process.Based on the ei¿s review of the third party report, no additional analysis is requested.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.

Manufacturer Narrative

H6 evaluation codes investigation conclusions was updated.

• Brand Name: GORE-TEX 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
• MDR Report Key: 10620266
• MDR Text Key: 209613536
• Report Number: 3003910212-2020-01107
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132610945
• UDI-Public: 00733132610945
• Combination Product (y/n): N
• PMA/PMN Number: K880167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2024
• Device Model Number: RRT06060080L
• Device Catalogue Number: RRT06060080L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 05/06/2021; 09/14/2021
• Supplement Dates FDA Received: 05/25/2021; 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 72 YR