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

Catalog Number	BXB077902A
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Reduced Blood Flow (4598)
Date of Event	03/03/2026
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 b20: the device remains implanted and was therefore not available for analysis.No images enabling direct assessment of product performance were returned for evaluation.H6 - code f28: device was misshapen due to another non-gore device during implant.Consequently, artery occlusion occurred.Ifu gore® viabahn® vbx balloon expandable endoprosthesis directions for use state: when using multiple endoprostheses to treat multiple lesions, it is recommended, wherever appropriate, to first treat the lesion that would obviate the need to cross the first endoprosthesis when placing the second or subsequent endoprosthesis.This would reduce the chance of disrupting or damaging the endoprostheses.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 to gore: on (b)(6) 2026, a patient underwent a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) procedure.During this procedure, the left renal artery (lra) was not pre-dilated.Two gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) devices were implanted successfully in the lra.On (b)(6) 2026, the physician reported the proximal lra was found to be occluded.Reportedly, the lra had a pre-existing medtronic endurant stent.The vbx device had a v-shape, and on imaging, it appeared the vbx stent was caught on an endurant strut during deployment, causing the abnormal shaped of the vbx device.As reported, there has been no intervention performed.

• 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: 24722943
• Report Number: 2017233-2026-07301
• Device Sequence Number: 13352331
• Product Code: PRL
• UDI-Device Identifier: 00733132658688
• UDI-Public: (01)00733132658688(17)280108
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: BXB077902A
• 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: 03/10/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2025
• 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: 74 YR
• Patient Sex: Male