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 Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
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.H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code b01: the engineering evaluation details observations made directly on the returned device in addition to device photos captured during evaluation.Evaluation of the returned device indicates the deployment line is broken and the knob plus line connected to the knob was not returned for evaluation.Deployment of the endoprosthesis was not started and could not be continued with traction at the endoprosthesis.Non-gore material was found on the hub of the device.The reported failure mode of failure to deploy is consistent with the findings of the engineering evaluation.The event description states the device was removed from the patient and deployed outside of the body when the deployment line broke.No deployment at endo was observed on the received device.Attempt to deploy with traction at endo, deployment would not initiate.The root cause of the reported failure mode and broken deployment line could not be established within the engineering evaluation.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: during treatment of a left carotid artery stenosis, a 7fr tour guide sheath was used to advance a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn® device) to the stenotic lesion area.As reported, no pre-dilation was performed.The viabahn® device reached the target site and deployment was started.However, the deployment line was stuck after about two inches of line unraveling.The constrained viabahn® device was pulled back through the sheath with no issues.A new viabahn® device was implanted with no issues.The patient did not experience any adverse consequences.It was reported the physician tried to deploy the removed device on the back table, but the deployment line broke.

• 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: 24536540
• Report Number: 2017233-2026-07230
• Device Sequence Number: 15710073
• Product Code: NIP
• UDI-Device Identifier: 00733132623761
• UDI-Public: (01)00733132623761(17)280501
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 49 YR
• Patient Sex: Male