MAUDE Adverse Event Report: W. L. Gore & Associates, Inc. GORE® VIABAHN® Endoprosthesis with HEPARIN Bioactive Surface; Stent, Superficial Femoral Artery

Catalog Number	VBHR081501A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, the patient underwent treatment for an aneurysm within a pre-existing av fistula using two gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn devices) that were intended to be placed in the arm.It was reported the physician advanced the viabahn devices through an 8f terumo sheath over a.035" glidewire guidewire.It was reported both viabahn devices prematurely dislodged from the delivery catheters after insertion.It is unknown if there was any resistance during advancement.It is also unknown if there was an attempt to deploy the viabahn devices and it is unknown what condition the deployment lines were in.It was reported, both viabahn devices were removed from the patient.To complete the procedure, it was reported the av fistula needed surgical conversion for repair.
Additional Manufacturer Narrative
H6 - c19: a review of the manufacturing records indicated the device met pre-release specifications.H6 - c21: results pending completion of investigation of the returned device.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.

• 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 ; +1(928)526-3030
• MDR Report Key: 50132714
• Report Number: 2017233-2026-07872
• Device Sequence Number: 18781698
• Product Code: NIP
• UDI-Device Identifier: 00733132623143
• UDI-Public: (01)00733132623143(17)290501
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 08/18/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: VBHR081501A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown