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

Catalog Number	BXA097902A
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	10/03/2025
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.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.No clinical images enabling direct assessment of product performance were returned for evaluation.Cause of the reported event cannot be established based on the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore 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.
Event or Problem Description
On (b)(6) 2025, a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) procedure was performed to treat a thoracoabdominal aortic aneurysm.As part of the procedure, gore® viabahn® vbx balloon expandable endoprostheses (vbx device) were used in the superior mesenteric artery (sma).On (b)(6) 2025, a type iii endoleak was identified in the sma branch, attributed to a disconnection of the vbx device implanted in (b)(6).The initial vbx stent graft did not achieve a complete seal at its distal edge, resulting in leakage into the aneurysm sac.To address this, a 9mm x 59mm vbx device was deployed approximately 3 cm distal to the original site to ensure proper seal.Deployment and expansion were reportedly smooth, with no resistance or complications.The balloon was positioned slightly higher to achieve a final diameter of 9.3mm successfully resolved the endoleak.Additionally, a 5mm x 29mm vbx device was placed in the left renal artery and extended to cover a branch suspected to be the source of a retroperitoneal bleed.The retroperitoneal bleed was identified prior to the endovascular treatment of the endoleak.Reportedly, the retroperitoneal bleed was not attributed to the vbx device.The exact cause of the bleed remains unknown, and details of the renal device placement are unclear.However, the aneurysm sac stopped filling after the sma intervention, suggesting that the resolution of the endoleak was not related to the renal artery procedure.

• 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: jazmin dela rosa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23359292
• Report Number: 2017233-2025-06733
• Device Sequence Number: 8797534
• Product Code: PRL
• UDI-Device Identifier: 00733132637607
• UDI-Public: (01)00733132637607(17)250605
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• 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): 10/22/2025

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 Expiration Date: 06/05/2025
• Device Catalogue Number: BXA097902A
• 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: 10/03/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male