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

Catalog Number	VBJR051002A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to gore: on (b)(6) 2025, a patient presented for treatment of an occluded femoro-popliteal artery.As reported, the patient had an implant procedure using the patient's vein approximately four months earlier.From the left common femoral artery access site, a 6fr x 65cm terumo sheath was inserted up and over the bifurcation to the occluded implant in the right leg.Over an.014 x 300cm v14 guide wire (bsc), a 5 x 15 gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn® device) was implanted distally and extended into the implanted vein.After device post dilation, the physician opted to implant another viabahn® device (5 x 10) for further distal extension.The viabahn® device was placed and deployment was started when the line broke inside the catheter.The physician was able to retract the constrained viabahn® device through the sheath with no issues.An additional viabahn® device was implanted proximal to the 5 x 15 viabahn® device to complete the procedure.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.H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6 - code b23: device was requested, but has not been returned as of today.Therefore, analysis cannot be done.No images enabling direct assessment of product performance were returned for 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.
Additional Manufacturer Narrative
D8/d9: fields updated for device return.H6 - code b01: the condition of the vsx device as returned for evaluation was consistent with the primary reported complaint of a broken deployment line during attempted deployment.The outer zipper of the vsx device as returned, was fully deployed to the turnaround and breakage of the deployment line was confirmed; there was no expansion of the endoprosthesis.The deployment failure was not replicated during evaluation.Deployment of the returned vsx device was able to continue when pulling the broken deployment line during evaluation, demonstrating that the deployment mechanism itself was not stuck.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.The root cause for the partial deployment and broken deployment line could not be established.

• 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: 22924673
• Report Number: 2017233-2025-06538
• Device Sequence Number: 9116548
• Product Code: NIP
• UDI-Device Identifier: 00733132623914
• UDI-Public: (01)00733132623914(17)271022
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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,Followup
• Report Date (Section B): 10/01/2025

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: VBJR051002A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2024
• 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: 29 YR
• Patient Sex: Female