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

Catalog Number S46045

Device Problem Patient-Device Incompatibility (2682)

Event Date 11/18/2016

Event Type  Injury  

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 the device remains implanted, 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 lot met all pre-release specifications.The physician stated that there is no allegation against the gore-tex stretch vascular graft and that the graft did not contribute to the steal syndrome.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

Gore received an adverse event alert from a retrospective vascular graft study.On (b)(6) 2016, the patient underwent surgical treatment for a humero axillary dialysis access with a gore-tex® stretch vascular graft.The device was implanted and retained and there were no adverse events during the procedure.The patient was discharged home 1 week later.The first order to dialyze through the graft was on (b)(6) 2016 and was successful.On (b)(6) 2016, the patient presented with a vascular steal syndrome on the humero-axillary prosthetic line.Professor rinckenbach stated that there is no allegation against the gore-tex stretch vascular graft and that the graft did not contribute to the steal syndrome.There was a reintervention on (b)(6) 2016, namely banding of the arterio-venous anastomosis.The patient was discharged home on (b)(6) 2016 and an ultrasound performed on (b)(6) 2016 showed that everything was ok.

• 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: 17675909
• MDR Text Key: 322613946
• Report Number: 2017233-2023-04248
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132611492
• UDI-Public: 00733132611492
• 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
• Report Date: 09/04/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: S46045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2016
• 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: 64 YR
• Patient Sex: Female