MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number	VBJR052502A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following patient information was asked to the physician but was not available: initials, gender, age, weight, date of birth, comorbidities, medications.A1: no patient specific details have been provided.Therefore, the patient identifier (in confidence) reflect the gore internal case number.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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 or Problem Description
On (b)(6) 2026, the patient underwent treatment for an aneurysm with stenosis in the upper region of an existing right femoral-popliteal bypass graft (unknown manufacture) using a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device).It was reported the lesion was pre-dilated and the delivery catheter advanced to the target treatment site through a 7f terumo pinnacle® destination® guiding sheath over a.035" terumo glidewire advantage guidewire successfully.When the physician attempted to deploy the endoprosthesis, it was reported one-third of the deployment line was pulled, when bowstringing was observed and deployment was ceased.The physician then withdrew the delivery catheter through the sheath with no delivery catheter damage or endoprosthesis distal expansion noticed.It was reported the viabahn device was deployed successfully on the back table and discarded.To complete the procedure, it was reported a new device was selected, advanced and deployed without incident.It was reported there was no patient impact.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: taylor moncrieff ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25244628
• Report Number: 2017233-2026-07539
• Device Sequence Number: 21204747
• Product Code: NIP
• UDI-Device Identifier: 00733132623938
• UDI-Public: (01)00733132623938(17)271210
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VBJR052502A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown