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

Catalog Number	SRRT06060080L
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Codes	Bacterial Infection (1735); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A study alert from the pvg 21-01 clinical study was received: on (b)(6) 2016, the patient underwent treatment for an occlusive peripheral artery disease in which a gore-tex® stretch vascular graft was used as a bypass for a femoro-peroneal procedure.The patient was discharged on (b)(6) 2016.Reportedly, the whole procedure was uneventful, vascular access was successfully gained, device deployed as intended, catheter was successfully removed and the patency of the devices were confirmed at the end of the procedure.The patient received an additional antiplatelet medication during the procedure.Reportedly on (b)(6) 2018 a graft infection was discovered, this was a recorded as device-related.An unspecified reintervention was administered and the patient required without a sequelae.
Additional Manufacturer Narrative
A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H3 code b20 and h6 : the device remains implanted in the patient.Therefore a device evaluation could not be performed.H6 code b14: a review of the manufacturing records indicated the lot met all pre-release manufacturing 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.
Additional Manufacturer Narrative
Emdr section h6 codes updated to reflect results of investigation.

• Brand Name: GORE-TEX® STRETCH 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17649094
• Report Number: 2017233-2023-04244
• Device Sequence Number: 15067153
• Product Code: DSY
• UDI-Device Identifier: 00733132612383
• UDI-Public: 00733132612383
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K903931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 12/18/2023

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: 11/01/2020
• Device Catalogue Number: SRRT06060080L
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Male