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

Catalog Number	VBHR100502A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was reported to gore: on (b)(6) 2024, a gore® viabahn® endoprosthesis (vsx device) was intended for use in the hypogastric artery during treatment of an aortic aneurysm.It was reported: the device was prepped as normal and very tortuous anatomy.The vsx device was advanced though a 12fr gore® dryseal flex introducer sheath over an 0.035" rosen guide wire and deployed without issue.However, during the removal of the delivery catheter the distal tip got hung up on the introducer sheath, the physician felt resistance and continued to pull.An angiogram was performed, and a foreign body was identified on the guide wire.The delivery catheter was inspected and showed the distal tip was not present.With the distal tip still on the guidewire, it was removed from patient with a snare.All parts were accounted for, and the procedure was completed.The patient did not experience any adverse consequences.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the device met pre-release specifications.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.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
The primary reported complaint of device catheter breakage was confirmed by evaluation of the returned device.However, the separation was observed between the catheter and distal shaft rather than the distal tip as reported.Evidence of prior bond formation between the distal shaft and catheter was observed.The device separation was reported to have occurred when the clinician continued pulling the device during withdrawal after resistance was encountered at the valve of the introducer sheath.Therefore, the root cause of the device breakage is consistent with the reasonably foreseeable misuse of forceful withdrawal.The device instructions for use provides special instructions to aid in release of the device in the event that it becomes caught at the introducer sheath valve during removal.

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20892722
• Report Number: 2017233-2024-05575
• Device Sequence Number: 12738173
• Product Code: NIP
• UDI-Device Identifier: 00733132646029
• UDI-Public: 00733132646029
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2026

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: VBHR100502A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: Not provided; 06/01/2026
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/07/2025; 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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: 61 YR
• Patient Sex: Male