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

Model Number ST0601

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Post Operative Wound Infection (2446)

Event Date 06/29/2015

Event Type  Injury  

Manufacturer Narrative

A4: patient weight was not made available.H3: the explanted vascular graft was not returned to gore facility.Therefore, direct product analysis was not possible.H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.Instructions for use for gore-tex® vascular grafts 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: redundancy; infection; ultrafiltration or perigraft seroma; thrombosis; mechanical disruption or tearing of the suture line, graft, and/or host vessel; excessive suture hole bleeding; formation of pseudoaneurysms due to excessive, localized, or large needle punctures; or perigraft hematomas.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

On (b)(6) 2015, a gore-tex® stretch vascular graft was implanted for dialysis access in a study patient's left arm.The vascular graft was implanted from brachial artery to cephalic vein with no issues.Patient was discharged to home on (b)(6) 2015.As reported, the most recent access prior to implant was a fistula in the patient's proximal left arm.This access was abandoned due to stenosis.On (b)(6) 2015, surgical site infection was observed.Per study information, this was a procedure-related infection that required medical or surgical intervention.On (b)(6) 2016, the vascular graft was explanted due to infection that spread to the vascular graft.The patient tolerated the procedure.

Manufacturer Narrative

Emdr section h6 codes updated to reflect results of investigation.Section h6: code d12-according to gore-tex® vascular grafts instructions for use (ifu), possible 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17373774
• MDR Text Key: 319623090
• Report Number: 2017233-2023-04136
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132612598
• UDI-Public: 00733132612598
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2020
• Device Model Number: ST0601
• Device Catalogue Number: ST0601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2015
• 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: 54 YR
• Patient Sex: Male