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

Catalog Number	VBJR080502A
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following patient information was asked to the physician but was not available: initials, gender, age, weight, date of birth, comorbidities, medications.A1: no patient specific details have been provided.Therefore, the patient identifier (in confidence) reflect the gore internal case number.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Engineering evaluation: the reported the distal tip of the device becoming fractured during withdrawal, could not be independently confirmed because no product nor images enabling direct assessment of product performance were returned for evaluation.Therefore, an independent assessment of deployment performance could not be conducted.It was reported the physician suspected tortuosity of the vessel and lack of support from the.018 guidewire contributed to the distal tip break; the physician stated a.035 wire may have performed better in this type of lesion.It was also reported that resistance was encountered during withdrawal of the device through the sheath, accounting for the distal tip of the device to be fractured.Per the device ifu, withdrawing the device back into the introducer sheath can cause damage to the endoprosthesis and/or catheter separation.Therefore, the cause of the broken catheter is consistent with the reasonably foreseeable misuse of the user attempting to withdraw a fully introduced device back through the introducer sheath.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 have not 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
On (b)(6) 2025, during an endovascular aneurysm repair (evar) procedure with another brand stent as the main graft, and a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) was to be deployed in the left common iliac artery.A 14 fr sentrant introducer sheath was used to advance the viabahn device over a 0.018¿ glidewire advantage wire.Due to the tortuous and aneurysmal nature of the patient¿s vessel, the viabahn device was unable to reach the intended treatment site.During withdrawal of the device through the sheath, resistance was encountered, and the distal tip of the device was fractured.The device was pulled back into the sheath, and both were removed as one unit.It was reported no components were left in the patient.The physician decided to advance the long sheath all the way past targeted treatment area to facilitate ease of advancement thru tortuosity then advanced a new same-sized viabahn device which was implanted successfully.The patient did not experience any adverse consequences.It was reported the physician suspects tortuosity of vessel and lack of support from 018 guidewire contributed to the distal tip break.Physician stated an.035 wire may have performed better in this type of lesion.

• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23414411
• Report Number: 2017233-2025-06754
• Device Sequence Number: 18743830
• Product Code: NIP
• UDI-Device Identifier: 00733132623815
• UDI-Public: (01)00733132623815(17)270814
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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
• Report Date (Section B): 10/29/2025

1 Device 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: VBJR080502A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2024
• 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