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

Catalog Number	VBCR050502A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of manufacturing records verified that the lot involved in this complaint met all pre-release specification.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 information was reported to gore: on (b)(6) 2025, the patient under went endovascular treatment of a venous anastomosis of an av graft with a gore® viabahn® endoprosthesis (vsx device).However, the deployment line got stuck when the physician was attempting to deploy this vsx device in the venous anastomosis of an av graft.He tried one more time but felt it was safer to remove this device.The physician successfully deployed a new vsx device to complete the procedure.The patient did not experience any adverse consequences.
Additional Manufacturer Narrative
Section h6 updated to reflect completion of investigation.Product investigation report conclusion: the primary reported failure mode, related to a stuck deployment line, is consistent with the engineering evaluation findings of failure to deploy when attempting deployment with the knob.Procedural and benchtop deployment of the device can be impacted by different factors including but not limited to zipper integrity, delivery system support or stiffness, or presence of dried fluid on the device or within the catheter dual lumen.The investigation could not confirm the cause of the reported hazardous situation nor the primary device failure mode.The returned device also exhibited forms of damage (e.G.Shifted endoprosthesis, exposed distal shaft).The cause for these damages could not be determined, but they are 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.Cause of the reported event cannot be established.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22899663
• Report Number: 2017233-2025-06532
• Device Sequence Number: 5854445
• Product Code: NIP
• UDI-Device Identifier: 00733132623334
• UDI-Public: (01)00733132623334(17)271008
• Combination Product (Y/N): N
• 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): 11/20/2025

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: VBCR050502A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown