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

Catalog Number	BXB067902A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Renal Impairment (4499)
Date of Event	02/28/2026
Type of Reportable Event	Serious Injury
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 b17: the device likely remained implanted and was, therefore, not available for analysis.No images enabling direct assessment of product performance were returned for evaluation.Two vbx devices were implanted in overlapped fashion in the renal artery, and reportedly both occluded.Two manufacturer reports will be submitted.The ifu was reviewed and the following statement was found to be applicable: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: stenosis, thrombosis or occlusion.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 via aaa 24-01 study: on (b)(6) 2025, the patient underwent a pararenal aneurysm endovascular procedure using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) device system.During this procedure, gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) devices were implanted as branch devices in the visceral arteries.It was reported the patient's left renal artery was plugged during this procedure.A preplanned procedure was also performed.A self-expanding stent graft (unknown manufacturer) was implanted in the patient's left subclavian artery.During patient's follow-up on (b)(6) 2026, cta performed showed the right renal artery was patent with no stenosis present.On (b)(6) 2026, the patient presented with an occluded right renal artery.As reported, intervention attempts were made the same day.On (b)(6) 2026, the patient expired due to cardiac arrest from multisystem organ failure.The physician stated the vbx devices did not contribute to the patient's death.

• 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: 24823866
• Report Number: 2017233-2026-07349
• Device Sequence Number: 5940045
• Product Code: PRL
• UDI-Device Identifier: 00733132658480
• UDI-Public: (01)00733132658480(17)280124
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: Study,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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: BXB067902A
• 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: 03/11/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2025
• 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; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White