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

Catalog Number	BXA117902A
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2025, a bilateral iliac branch endoprosthesis (ibe) procedure was performed due to infrarenal aortic aneurysm and bilateral iliac artery aneurysms.Two gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) were implanted in the right hypogastric artery.An 8lmm x 79mm vbx device was implanted distally and an 11mm x 79mm vbx device implanted proximally and flared to 14mm inside the ibe gate with full 2.5cm overlap.Contrast was observed outside of ibe and inside iia aneurysm at this time, with possible type iii endoleak.The patient¿s hypogastric artery had a 360 degree turn and it was straightened with a stiff guidewire to implant the vbx devices.Once the stiff guidewire was removed the vessel tortuosity returned, potentially disconnecting the vbx devices.On (b)(6) 2025, revision was for percutaneous transluminal angioplasty of the implanted vbx devices in the hypogastric artery.Access was gained from the brachial artery.A type iii endoleak between the two vbx devices was confirmed.The physician chose to reline and reconnect the vbx devices.An 8fx90cm terumo destination sheath was used to advance the first vbx device (8lmm x 79mm), followed by deployment of an 11mm x 59mm vbx device.A 14mm pta balloon was used to seal the vbx devices into the ibe gate.The procedure ended with satisfactory results and the patient did not experience any adverse consequences.
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: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H6 - code b20: the devices remain implanted and was, therefore, not available for analysis.No images enabling direct assessment of product performance were returned for evaluation.D15.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.

• 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: 23415038
• Report Number: 2017233-2025-06755
• Device Sequence Number: 12998299
• Product Code: PRL
• UDI-Device Identifier: 00733132637768
• UDI-Public: (01)00733132637768(17)270909
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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
• Report Date (Section B): 10/29/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: BXA117902A
• 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: 10/17/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2024
• 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: 18 YR
• Patient Sex: Male