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

Catalog Number	BXB065902A
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2021, a patient underwent endovascular treatment for infrarenal abdominal aortic aneurysm.The patient tolerated the procedure.On (b)(6) 2024, intervention using a snorkel/chimney technique was performed due to a proximal type i endoleak.A gore® excluder® conformable aortic extender endoprosthesis was implanted.A gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was implanted into the left renal artery.The endoleak was resolved.On (b)(6) 2025, imaging provided to gore for evaluation showed a proximal type i endoleak/gutter leak.The leak appeared to originate around the vbx device at the left renal artery, and near the gore® excluder® conformable aortic extender endoprosthesis.Imaging also showed aneurysm enlargement from 5.5 cm to 6.2 cm.On (b)(6) 2025, the patient underwent reintervention and a new gore® excluder® conformable aortic extender endoprosthesis was implanted proximally to resolve the endoleak.The patient tolerated the procedure.
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.H6 - code b20: device remains implanted.Imaging provided by user facility indicated type 1 endoleak that required an intervention with additional device placement.H6 - code c19: review of device manufacturing record history confirmed device met pre-release specifications.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.
Additional Manufacturer Narrative
The imaging evaluation was performed by a clinical imaging specialist: one time point available for evaluation: post-implantation cta dated on (b)(6) 2025.Axial image shows contrast outside the stent in the aorta and left renal artery.The length from the left renal artery to the contrast pooling in the sac appears to be 15.9 mm, by centerline.There is a right accessory renal artery distal to the level of the left renal artery.The length from the right accessory renal artery to the contrast pooling in the sac appears to be 13.0 mm, by centerline.Cannot confirm with available imaging if this is a type i (gutter) endoleak or a type ii involving a lower right accessory renal artery.Endoleak of unknown origin.H6: code c22: endoleak is observed, but origin or type is unknown.

• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21337767
• Report Number: 2017233-2025-05809
• Device Sequence Number: 20940451
• Product Code: PRL
• UDI-Device Identifier: 00733132658466
• UDI-Public: (01)00733132658466(17)270530
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 03/04/2025

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: BXB065902A
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2024
• 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: 84 YR
• Patient Sex: Male