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

Catalog Number	RRT07070080L
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	10/14/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8245010
• Report Number: 2017233-2019-00016
• Device Sequence Number: 2203303
• Product Code: DSY
• UDI-Device Identifier: 00733132611034
• UDI-Public: 00733132611034
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K802095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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: 01/11/2023
• Device Catalogue Number: RRT07070080L
• Device Lot Number: 17638275
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 05/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR