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

Catalog Number	VBHR091002A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to gore: during treatment of a popliteal artery aneurysm, an 8fr ansel cook sheath was used to advance a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) over an.035glidewire advantage.The viabahn device was implanted at the intended treatment site.After deployment, the distal shaft of the catheter became detached while it was being withdrawn.The physician was able to retrieve the broken piece using a snare.The procedure was completed successfully.The patient did not experience any adverse consequences.
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.A4: patient weight was requested but not made available.Patient medical history and medication information were requested but not made available.H6: code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6: code c21: the viabahn stent remains implanted and deployment line and deployment hub were not returned.The delivery catheter was returned and results are pending completion of investigation.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.
Additional Manufacturer Narrative
H6: code b20: the broken delivery catheter was returned.Engineering evaluation state: the primary reported failure mode, detachment of the distal shaft from the delivery system during device removal from the patient following deployment, was confirmed through engineering evaluation of the returned device.The device was returned with a kinked distal shaft that had pulled out of the transition.Evidence of bonding between the distal shaft and the transition was identified during the evaluation in the form of a braid pattern, consistent with the outside surface of the distal shaft, visible within the transition component at the bond site.The kinked and detached distal shaft are consistent with a device interaction during withdrawal, but there is no reported information describing such an interaction.The specific cause for the distal shaft detachment could not be established with the available information.
Additional Manufacturer Narrative
Investigation was re-opened.Product investigation report conclusion state: the primary reported failure mode, related to distal shaft detachment, is consistent with the findings from the engineering evaluation of a separated distal shaft from the transition.While there is evidence that the transition and dual lumen went through the bonding process, the visible collar that does not meet the in-process inspection criteria indicates that the bond was inadequate, and the device should have been rejected during the manufacturing process.Therefore, the root cause of the primary reported failure mode is consistent with a manufacturing deficiency.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20338644
• Report Number: 2017233-2024-05361
• Device Sequence Number: 7999841
• Product Code: NIP
• UDI-Device Identifier: 00733132645985
• UDI-Public: 00733132645985
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2025

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: VBHR091002A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 11/15/2024; 08/13/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/18/2024; 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2024
• 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 Age: 70 YR
• Patient Sex: Male