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

Model Number SAX01D

Device Problem Complete Blockage (1094)

Patient Problem Stenosis (2263)

Event Date 05/05/2022

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 and the result of investigation would be communicated in the final report.A review of the manufacturing records indicated the lots met all pre-release specifications.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, on (b)(6) 2020, this patient underwent surgical treatment for a distal aortic occlusion which caused lower limb ischemia.A gore-tex® stretch vascular graft was used in this procedure.Reportedly, on (b)(6) 2022, after 2 years and 2 months, a part of the graft was explanted during a new surgical procedure due to stenosis.

Manufacturer Narrative

The complaint was reviewed and was determined to be non reportable because the stenosis occurred greater than 30 days post implant.Stenosis occurring greater than 30 days post-implant is not design specific and is a well-known and acceptable risk of endovascular or surgical procedures.Stenosis occurring after 30 days cannot be directly attributed to a performance failure of the vascular graft but rather as a consequence of the unnatural physiological state created by connecting a vein and artery.Therefore the mir report is being retracted.

• 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: 16589329
• MDR Text Key: 311739968
• Report Number: 2017233-2023-03807
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132611768
• UDI-Public: 00733132611768
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K904282
• 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
• 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 Model Number: SAX01D
• Device Catalogue Number: SAX01D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2019
• 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: 63 YR
• Patient Sex: Male