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

Catalog Number	BXB057902A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm.The procedure was completed with no reported issues, and no endoleaks were observed at the close of the procedure.A gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was implanted in the left renal artery.It was reported that follow-up imaging was performed and a suspected type iii endoleak was observed from the left renal portal.It was suspected that additional ballooning may be required and may be the cause of the endoleak.A reintervention will be performed at a later date.
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.
Additional Manufacturer Narrative
Added - additional information to describe event or problem section.Updated - h6 adverse event problem codes based on investigation finding/conclusion.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.An imaging evaluation performed by a clinical imaging specialist confirmed an endoleak of unknown type.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use adverse events potential clinical and device adverse events section states, possible adverse events and complications that may occur with the use of this device or in any endovascular procedure and require intervention include, but are not limited to (shown in english alphabetical order): endoleak and/or endotension.
Event or Problem Description
On october 16, 2025, additional information was provided regarding the endoleak.On (b)(6) 2025 a scheduled reintervention surgery occurred.The physician angiographically interrogated the stent branches, especially the left renal branch, and could not produce an endoleak.Physician concluded that the leak evidenced on the previous ct scan, was most likely a type 2 leak.Physician indicated that he would continue to monitor this patient and the leak diligently.

• 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23054303
• Report Number: 2017233-2025-06603
• Device Sequence Number: 12953287
• Product Code: PRL
• UDI-Device Identifier: 00733132658367
• UDI-Public: (01)00733132658367(17)270826
• 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): 10/28/2025

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: BXB057902A
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2024
• 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: 77 YR
• Patient Sex: Male