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

Catalog Number ST0804

Device Problems Partial Blockage (1065); No Apparent Adverse Event (3189)

Patient Problem Stenosis (2263)

Event Date 10/21/2021

Event Type  Injury  

Manufacturer Narrative

H6-b14 and c19: a review of the manufacturing records.[manufacturing/boxing/sterilization/packaging] indicated the lot met all pre-release specifications.H6-b20 and h3-other: the device remains implanted in the patient.Therefore a device evaluation could not be performed.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) 2016, the patient underwent surgical treatment with a gore-tex® stretch vascular graft to treat an occlusive peripheral arterial disease.The procedure was completed without any complications.Reportedly on (b)(6) 2016, an adverse event termed "stenosis of the right femoral bifurcation" was discovered, the primary relationship was recorded as procedure related.A reintervention (not further specified) was performed and the patient recovered without a sequelae.

Event Description

Reportedly on (b)(6) 2016, the patient underwent surgical treatment with a gore-tex® stretch vascular graft to treat an occlusive peripheral arterial disease of the right leg.The proximal anastomosis was at the right prosthetic branch of a previously implanted aorto-bifemoral bypass (not specified), the distal anastomosis was above the knee at the femoral artery.The procedure was completed without any complications.Reportedly on (b)(6) 2016, an adverse event termed "stenosis of the right femoral bifurcation" was discovered, the primary relationship was recorded as procedure related.The site study coordinator stated that the gore-tex® stretch vascular graft was not stenosed, the right common femoral artery was stenosed instead.An excision of the right common femoral artery was performed and the gore-tex® stretch vascular graft was prolonged with another gore-tex® graft (not further specified).The patient recovered without sequelae.

Manufacturer Narrative

B5: updated event description cause investigation and conclusion: rationale for why the event is considered not reportable: this complaint was initiated based on information received from an automated alert of a retrospective study on (b)(6) 2023.The database entries were reviewed and the provided information was captured in sections 2 and 3.Several requests were sent to the study site to further clarify the event, on (b)(6) 2023, additional information to the event was provided by the study site.The provided information was captured in the updated event description.A review of the manufacturing records indicated the lot met all pre-release specifications.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.The cause of the reported stenosis of the native common femoral artery remains unknown.From the description of the incident, it appears that the gore-tex® stretch vascular graft was not affected by the stenosis.Therefore the available information does not reasonably suggest a potential malfunction has occurred.No allegation of device malfunction was indicated with respect to device performance.The description of the incident therefore no longer meets the criteria of a reportable incident.The incident description no longer meets the criteria of a reportable incident and therefore it was 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17581218
• MDR Text Key: 321519086
• Report Number: 2017233-2023-04215
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132612734
• UDI-Public: 00733132612734
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K933943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2021
• Device Catalogue Number: ST0804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2016
• 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; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female