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

Model Number	RRT06060080L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/24/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1 code: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H6: b20 and h3 other code: the medical device remains implanted and therefore couldn't be evaluated.H6 code b13: further additional information was requested from the physician and will be communicated in the next report.H6 code b14: 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 or Problem Description
The following was reported to gore: reportedly on (b)(6), 2014, this patient underwent a procedure for the treatment of an occlusive peripheral arterial disease in which a gore-tex® vascular graft was used as a bypass (femoro-tibial bypass).Reportedly, the whole procedure was uneventful, access was successfully gained, device deployed as intended, catheters were successfully removed and the patency of the device was confirmed at the end of the procedure.The patient received heparin during the procedure.According to reports, on (b)(6), 2014 an adverse event termed " thrombosis of the gore left femoro tibial anterior bypass" was discovered.The relationship was recorded as disease-related and it was recorded that the adverse event required treatment.
Additional Manufacturer Narrative
H6: corrected imdrf codes.

• Brand Name: GORE-TEX® 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: wilson okeke ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16834225
• Report Number: 2017233-2023-03894
• Device Sequence Number: 20971421
• Product Code: DSY
• UDI-Device Identifier: 00733132610945
• UDI-Public: 00733132610945
• 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: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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: 10/20/2018
• Device Model Number: RRT06060080L
• Device Catalogue Number: RRT06060080L
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2013
• 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
• Patient Sex: Female