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

Catalog Number	BXA077902A
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2025 from the aaa-1701 medrio study database: on (b)(6) 2023, this 63-year-old male patient underwent an endovascular percutaneous procedure for a type iv aortic aneurysm.A tambe device was planned for this patient.The left renal artery was treated with a gore® viabahn® vbx balloon expandable endoprosthesis device.The patient was treated with multiple devices; all tambe system components were successfully tracked from the access site to the intended implantation site and released from delivery catheters successfully.On (b)(6) 2024, this patient was noted to have left renal artery occlusion.It is noted as related to the device and treatment was required.On (b)(6) 2024, the patient underwent successful endovascular recanalization of the left renal artery with thrombectomy and balloon angioplasty.The adverse event was noted as resulting in renal failure, but the patient did not receive dialysis.The adverse event was noted as resolved with sequelae on (b)(6) 2024.The patient discharged from the hospital on (b)(6)2024.On (b)(6) 2024, this patient was noted to have left renal artery stenosis.It is noted that it is related to the study device, but that treatment was not required.The adverse event is noted to be ongoing.
Additional Manufacturer Narrative
Section h6 updated to reflect completion of investigation.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.

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21725186
• Report Number: 2017233-2025-06000
• Device Sequence Number: 9419141
• Product Code: PRL
• UDI-Device Identifier: 00733132637539
• UDI-Public: (01)00733132637539(17)250417
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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: 04/17/2025
• Device Catalogue Number: BXA077902A
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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: Other; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 98 KG