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

Model Number SRRT06060080L

Device Problem Microbial Contamination of Device (2303)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2022

Event Type  Injury  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.The medical device returned to a third party for investigation.The analysis report will be shared with gore and will be evaluated appropriately.A review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.The information reported in the complaint, including a report from third party lab, does not reasonably suggest a potential malfunction or product packaging and/or labeling issue has occurred.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 Description

Reportedly, the patient underwent surgical treatment with a gore-tex® vascular graft.It was recorded that the vascular graft was implanted on (b)(6) 2022, as a femoral-popliteal bypass due to a peripheral artery disease.Reportedly, on (b)(6) 2022, after 11 days, the graft was explanted due to an infection.

Manufacturer Narrative

H6: corrected imdrf codes.

Manufacturer Narrative

Corrections to codes in h6: code c19: review of device manufacturing record history confirmed device met pre-release specifications.H3 'other' code and code b15: gepromed observations: the internal and external sides of the prosthesis are both covered with some biological tissues.One sample is obstructed by thrombotic materials while the other sample is folded on to itself.The macroscopic level 1 analysis of the explanted graft does not reveal any defects, either on the eptfe membrane or on the rings.A histological analysis could be carried out followed with an in-depth analysis after the cleaning of the graft to study the eptfe structure.Gore observation: additional analysis of the specimen would only confirm the presence of infection with no additional information provided for the role of the device.Based on the explant scientist¿s review of the gepromed report, no additional analysis was requested.

• Brand Name: GORE-TEX® STRETCH VASCULAR GRAFT
• Type of Device: 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: 16349376
• MDR Text Key: 309265510
• Report Number: 2017233-2023-03712
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132612383
• UDI-Public: 00733132612383
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K933943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SRRT06060080L
• Device Catalogue Number: SRRT06060080L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Male