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

Catalog Number	BXB055902A
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	08/14/2025
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.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 details were reported to gore: on (b)(6) 2025, the patient underwent endovascular treatment of the right and left renal arteries with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).On (b)(6) 2025, reportedly, the patient had very small renal vessels and were shut down for over 24 hours.The physician attempted a reintervention on both renal arteries.It appeared that both vbx device's may have been compressed (possibly by an aortic balloon).The physician could only get access into the right renal because of tortuosity.The right renal artery was declotted with tissue plasminogen activator and penumbra device and then a vbx device was placed to make sure it stays open.The right renal looked great angiographically after the procedure.Post procedure - patient recovering.The physician placed a dialysis catheter into the patient for use.On (b)(6) 2025, the patient was not making urine.No further updates were provided.
Additional Manufacturer Narrative
Section h6 updated to reflect completion of investigation.The manufacturing records were reviewed and documented in the product history task.The device lot met all pre-release specifications.Product investigation report conclusion - the primary reported complaint could not be independently confirmed because there were no items returned for evaluation.As reported, the vbx device may have been compressed during the index procedure, possibly by an aortic balloon; this was unable to be definitively confirmed or refuted.Therefore, the cause for the reported vbx device compression could not be determined with the available information.

• 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: 22973237
• Report Number: 2017233-2025-06569
• Device Sequence Number: 9137559
• Product Code: PRL
• UDI-Device Identifier: 00733132658343
• UDI-Public: (01)00733132658343(17)271221
• 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: 2025
• 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): 12/03/2025

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 Catalogue Number: BXB055902A
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female