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

Catalog Number RRT07070080L

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Thrombosis (2100)

Event Date 10/14/2018

Event Type  Injury  

Event Description

It was reported to gore that a gore-tex® vascular graft was implanted on (b)(6) 2018, in a (b)(6) male patient to treat an acute ischemia located at the right lower limb.On (b)(6) 2018, after about 8 days, the gore-tex® vascular graft was explanted due to a thrombosis leading to a transfemoral amputation.

Manufacturer Narrative

Additional information was entered for the following: result code 213: a review of the manufacturing records confirmed that the lot met all pre-release specifications.Result code 213: refer to explant evaluation summary.The gore-tex® vascular graft was returned to geprovas, independent laboratory, for investigation.The scope and results of the investigation were summarized and a report was submitted to w.L.Gore & associates.An explant investigator (ei) at w.L.Gore & associates reviewed the report.The following is a summary of the ei observations: minimal, scattered plaques of dark red/brown material on the albumen surface.Lumens were fully obstructed with dark red/brown and white/tan thrombotic material.Both poles were transected.Extremity a was ovular in shape.No defect on the eptfe membrane was observed during the macroscopic analysis.From gross images all material disruptions (i.E., material transections), appear to be consistent with cutting by sharp surgical instruments (i.E., scalpel or scissors), likely used during the explant procedure.Further analysis is not needed as the material disruptions are consistent with those caused by surgical instrumentation during the explant process.

• Brand Name: GORE-TEX® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8245010
• MDR Text Key: 132965691
• Report Number: 2017233-2019-00016
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132611034
• UDI-Public: 00733132611034
• Combination Product (y/n): N
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Catalogue Number: RRT07070080L
• Device Lot Number: 17638275
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR