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

Catalog Number S0604

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 09/01/2016

Event Type  Injury  

Event Description

Gore received an adverse event alert from a retrospective vascular graft study.On (b)(6) 2016, the patient underwent surgical treatment for the creation of a vascular access graft brachio-basilic in the left arm for hemodialysis with a gore-tex® stretch vascular graft, because of an access site infection of a jugular catheter.The device was implanted and retained and there were no adverse events during the procedure.The patient was discharged home on (b)(6) 2016, and the first order to dialyze through the graft successfully was on (b)(6) 2016.On (b)(6) 2016, the patient presented with an infection of the prosthetic loop graft.Medical or surgical intervention was needed, and treatment required.The issue was resolved on (b)(6) 2016.The study was discontinued, as the device was explanted.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the study number with codes for the hospital and patient.H3 other code: as it is unknown, if the device is available, no further investigation can be performed.H6 evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing records indicated the lots met all pre-release specifications.The physician was contacted and further details requested.Further investigation is being conducted and will be included in the final report.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.

Manufacturer Narrative

This mwr report was submitted by human error and therefore this report is being retracted.Reason for vascular graft implantation was access site infection of a cvc.No systemic infection was reported, instead local infection was reported.No information was provided as to whether this local infection affected the brachio-basilic av bypass graft during or after implantation.When comparing access sites for cvc and brachio-basilic av bypass graft, it is reasonable to assume that local cvc access site infection does not affect a brachio-basilic av bypass graft implantation.It was reported that the av bypass graft was repeatedly cannulated for hemodialysis as of (b)(6), 2016.(b)(6) 2016, was given as the onset date of the brachio-basilic av bypass graft infection.The event description, no further information was provided, the anatomical locations of access sites and the chronological sequence reasonably suggest a connection between graft cannulation and infection.Gore´s internal worldwide reporting guideline states that for event categories"infection, graft", a graft which was previously cannulated for av access is considered not reportable.

Manufacturer Narrative

As the status of the device is unknown, no further investigation of the device can be performed.Neither clinical images enabling direct assessment of product performance, nor the device was returned for evaluation.Multiple attempts were made to obtain additional information about this event from the physician, like how was the infection diagnosed, was this a systemic bacterial infection, are bacteriology findings available that confirm the infection, was the explanted gore device replaced by another device, was there a pre-existing infection in the field of treatment and/or was there an infection at the access site? no further details were provided.With the information provided to gore, the cause of the reported event cannot be established.In the instruction for use for the gore-tex® stretch vascular graft the following is stated: possible complications with the use of any vascular prosthesis complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: infection.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17676110
• MDR Text Key: 322621629
• Report Number: 2017233-2023-04249
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132611294
• UDI-Public: 00733132611294
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K903931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2021
• Device Catalogue Number: S0604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2016
• 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): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male