MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Catalog Number	BXB085902A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: the patient had a history of undergoing a procedure in which a physician modified graft (pmeg) was implanted.It was reported a non-gore stent was also implanted the superior mesenteric artery (sma) during this procedure.It was reported the pmeg was leaking into the aneurysm.To address the aneurysm growth, plans were made to use a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) to reline the existing modified graft.On (b)(6) 2025, the patient underwent the tambe procedure.A gore® excluder® thoracoabdominal branch endoprosthesis (tambe) and gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) were implanted.It was reported after the tambe aortic component device was implanted.During cannulation of the sma, the physician inadvertently caused a dissection while advancing the guidewire into the existing non-gore stent.As reported, the dissection was covered with deployment of the vbx device into portal of the tambe device.The vbx device was deployed with no issues.The procedure was completed with no further issues, and the patient tolerated the procedure it was reported that on (b)(6) 2025, the patient died due to mesenteric ischemia.It was reported that at the end of the procedure, final imaging showed good results and no dissection was evident.The physician stated he attributes the patient's death to complications from the dissection leading to mesenteric ischemia, and not to any implanted gore devices.
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 b14 and b20: device medical history is under evaluation; results pending completion of investigation.Device remains implanted; therefore, direct product analysis was not available.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
After further evaluation, it was determined this complaint is not reportable as the vbx device deployed as intended, and the final imaging did not show any remaining dissection or bleeding.The procedure ended with good results and the patient tolerated the procedure.The physician confirmed the adverse event is not attributed to any of the gore devices.Therefore, this report is submitted for retraction.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• 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: 24031073
• Report Number: 2017233-2026-07036
• Device Sequence Number: 8859646
• Product Code: PRL
• UDI-Device Identifier: 00733132658749
• UDI-Public: (01)00733132658749(17)280709
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 01/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: BXB085902A
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2025
• 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 Age: 63 YR
• Patient Sex: Female