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	Stenosis (2263)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A study alert from pivotal aaa17-01 (tambe) clinical study was received: device compression is at the transition of bridging stent to the native renal, so this location of this compression affects both components.On (b)(6) 2020, a aaa procedure was performed and a tambe device was implanted in a study patient.During this procedure, gore® viabahn® vbx balloon expandable endoprosthesis (vbx device/stent) were implanted as branch devices in the visceral arteries.Two vbx device/stent were implanted in the renal artery.During a follow-up on (b)(6) 2025, imaging was performed.Observed device compression at the transition of bridging stent to the native renal, so this location of this compression affects both vbx device/stents in the renal artery.There were no reported fractures, and the branch devices remain patent.No intervention was reported.The patient is scheduled for a right renal angiogram on (b)(6) 2025.
Additional Manufacturer Narrative
Manufacturing records were reviewed, and the device met all pre-release specifications.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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 wor.
Additional Manufacturer Narrative
Section h6 updated to reflect completion of investigation.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.
Additional Manufacturer Narrative
On (b)(6) 2025, the patient underwent right renal artery selective angiography and stenting for right renal artery branch compression due to stent graft stenosis.

• 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: 21378439
• Report Number: 2017233-2025-05830
• Device Sequence Number: 18250726
• Product Code: PRL
• UDI-Device Identifier: 00733132637539
• UDI-Public: (01)00733132637539(17)230610
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2023
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 04/24/2025; 07/29/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 04/24/2025; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2020
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Race: Asian