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

Catalog Number S0604

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Ischemia (1942); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/24/2019

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 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.

Event Description

Gore received an adverse event alert from a retrospective vascular graft study.On june 4, 2019, the patient underwent surgical treatment for the creation of a vascular access graft for hemodialysis brachio-basilic in the left arm 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 two days later.On (b)(6) 2019, the patient presented with a vascular steal syndrome which needs medical or surgical intervention.The issue was resolved on (b)(6) 2019, by closing of the left brachio-basilic prosthetic line.The full device was explanted as part of the reintervention.As primary relationship procedure-related was mentioned.

Manufacturer Narrative

H6 evaluation codes health effect - clinical code e2402 was used for appropriate term not available used for ¿steal syndrome".H6 evaluation codes medical device problem code a27 was used for prophylactic removal of a device due to corrective action without malfunction or problem of the specific device involved.This complaint was initiated based on information received from a study alert.The data provided within the study database were reviewed.No further information was provided to gore.A prophylactic removal of a device was performed due to corrective action without malfunction or problem of the specific device involved.With the available information, we are unable to determine the cause of this incident and assign a root cause.

• 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: 17937970
• MDR Text Key: 325675508
• Report Number: 2017233-2023-04333
• 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
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2023
• Device Catalogue Number: S0604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2018
• 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: 83 YR
• Patient Sex: Male