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

Catalog Number	VBJR060502A
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
The following was reported to gore: on (b)(6) 2025, a patient underwent an endovascular procedure for claudication in peripheral vascular disease.The procedure performed was a left lower extremity angiogram with intervention utilizing a gore® viabahn® endoprosthesis with heparin bioactive surface.During the procedure, the delivery system catheter advanced through an unknown size/brand introducer sheath over an unspecified size/brand guidewire to the target treatment site.The exact anatomical location being treated was not provided.It is unknown if the target lesion was pre-dilated.The delivery catheter reached the intended treatment site.During deployment, the deployment line was pulled, but prior to the completion of deployment, the line became stuck.Several attempts to continue deployment were made but were unsuccessful.The deployment line could be visualized at the location of the stent and was putting enough tension on the stent and catheter to curve the end of the catheter slightly.The delivery catheter was withdrawn from the patient over the wire, and was reportedly intact.
Additional Manufacturer Narrative
Updated h6 adverse event problem codes.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Product return evaluation: the returned device also exhibited an exposed distal shaft of the catheter.The cause for this damage could not be determined, but it is consistent with damage resulting from the reported inability to deploy, an unknown device interaction during withdrawal, or manipulation of the device either during or after the procedure.The reported stuck deployment line, is consistent with the engineering evaluation findings of the outer zipper being deployed to the turnaround and unsuccessful deployment at the hub and endoprosthesis.The investigation could not confirm the cause of the reported issue.

• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24082051
• Report Number: 2017233-2026-07052
• Device Sequence Number: 12232096
• Product Code: NIP
• UDI-Device Identifier: 00733132623952
• UDI-Public: (01)00733132623952(17)280928
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 02/05/2026

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: VBJR060502A
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• 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