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

Catalog Number	VBJR070502A
Medical Device Problem Codes	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, the patient underwent treatment for stenosis using a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) that was intended to be placed in the right external iliac artery.It was reported the viabahn device was advanced through a 7fr (55 cm) cook flexor ansel guiding sheath over a.018" (300 cm) abbott hi-torque steelcore guidewire.Reportedly, the target treatment site was not predilated but the viabahn device successfully reached the target treatment site.Upon attempted deployment, it was reported that the deployment line broke after an unknown length of the deployment line was pulled.It is unknown if there was any resistance felt.It was reported the endoprosthesis remained on the delivery catheter, fully constrained, and was removed in tandem with the delivery catheter through the sheath.Upon withdrawal, it was reported there was no endoprosthesis expansion noticed.Reportedly, there were no signs of delivery catheter breakage or detachment and no deployment line left inside the patient.It was reported there was no calcification and/or tortuous anatomy present.To complete the procedure, two new viabahn devices were selected for use.There was no patient harm reported.
Additional Manufacturer Narrative
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.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: 50917057
• Report Number: 2017233-2026-08093
• Device Sequence Number: 20181768
• Product Code: NIP
• UDI-Device Identifier: 00733132623761
• UDI-Public: (01)00733132623761(17)280613
• Combination Product (Y/N): Y
• Initial Reporter State: AK
• 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
• Report Date (Section B): 09/28/2026

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: VBJR070502A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2025
• 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 Age: 32 YR
• Patient Sex: Male
• Patient Weight: 151 LB