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

Catalog Number	BXB075902A
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	03/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Gore® viabahn® vbx balloon expandable endoprosthesis (serial #(b)(6); udi #(b)(4).And gore® viabahn® vbx balloon expandable endoprosthesis (serial #(b)(6); udi #(b)(4).Were all overlapped and implanted in same anatomical location.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 have not 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) 2024, the patient underwent an endovascular tambe procedure to treat an aneurysm utilizing gore® excluder® thoracoabdominal branch endoprosthesis, gore® excluder® aaa endoprosthesis and gore® viabahn® vbx balloon expandable endoprosthesis.On (b)(6) 2025, the patient underwent a reintervention procedure as there was contrast in the aneurysm sac, but physician could not determine if it was a type 2 endoleak from the lumbar arteries or a leak from the left renal artery.Then an angio was performed but the cause of the contrast was still undetermined as it was in the area of the left renal artery.The left renal stents did have adequate length and were sized appropriately with adequate overlap from the original procedure.The physician decided to re-line the left renal viabahns (bxb067902a and bxb075902a) with an additional bxb067902a stent and place it a little deeper into the renal with more overlap.Patient is doing okay.The contrast density in the sac was reduced, however, physician stated that they won¿t know with certainty until the 30-day follow up ct scan is performed.
Additional Manufacturer Narrative
Section h6 updated to reflect completion of investigation.Manufacturing records were reviewed, and both devices met all pre-release specifications.The devices remain implanted and, 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.

• 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: 21733612
• Report Number: 2017233-2025-06009
• Device Sequence Number: 14508835
• Product Code: PRL
• UDI-Device Identifier: 00733132658664
• UDI-Public: (01)00733132658664(17)270722
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: BXB075902A
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2024
• 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
• Patient Age: 81 YR
• Patient Sex: Male