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 Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the patient underwent an emergent endovascular procedure to treat a ruptured aortoiliac aneurysm using a gore® excluder® conformable aaa endoprosthesis and multiple vbx devices in the left external iliac artery.Both vbx devices and their overlap with an innova stent were post-dilated.Approximately 1.5 cm of overlap was achieved between the vbx devices at implantation.The procedure was successful, and no endoleaks were observed at completion.The patient was discharged home on (b)(6) 2025 without reported complications.Follow-up imaging included an initial one-month scan that showed no evidence of endoleak.On (b)(6) 2026, during a subsequent cta (approximately six months later), a type iiia endoleak was identified for the first time.Imaging demonstrated approximately 2 cm of separation between the second and third vbx devices, measured using a ruler tool on cta.The endoleak was ongoing at that time.The physician assessed that the likely cause of the endoleak and device separation was insufficient overlap between the devices in the setting of a known iliac aneurysm, which likely continued to enlarge and contributed to device separation.A reintervention was performed on (b)(6) 2026.The procedure involved relining of the left iliac limb and iliac stents using a 12x14 and a 10x7 gore devices.The endoleak was successfully resolved following the intervention.The patient is currently clinically stable and doing well, having been discharged the same day of the reintervention without complications.
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.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.The device remains implanted and was, therefore, not available for analysis.Based on the information reported, the physician assessed that the likely cause of the endoleak and device separation was insufficient overlap between the devices in the setting of a known iliac aneurysm, which likely continued to enlarge and contributed to device separation.Therefore, the event is attributed to unintended use error, which caused or contributed to the event.Further information regarding this event was requested by gore; however, no additional information has been provided.This investigation is considered complete.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: vanessa rodriguez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25249891
• Report Number: 2017233-2026-07541
• Device Sequence Number: 10500606
• Product Code: PRL
• UDI-Device Identifier: 00733132637768
• UDI-Public: (01)00733132637768(17)280426
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: 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: 04/30/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male