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

Catalog Number	BXB087902A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	03/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the patient underwent endovascular treatment of a zone 5 descending thoracoabdominal aortic aneurysm using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) in the superior mesenteric artery (sma).On (b)(6) 2026, the patient underwent a reintervention due to occlusion of the sma stent.The endoprosthesis in the sma was found to be occluded and was 'bending' out of the portal.However, it was noted the collateral vessels were filling, and there was a concern regarding additional radiation exposure, therefore no further intervention of the sma was performed.No additional treatment plan is currently in place.
Additional Manufacturer Narrative
A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Engineering evaluation: the reported structural deformation or malalignment of the stent graft was confirmed by imaging evaluation as evidenced by occluding thrombus that appeared to extend and ¿bend¿ out of the device.Occlusion to the sma was confirmed, and this was the indicated treatment location of the vbx device.Procedural considerations include side branch alignment relative to the main aortic component portals.However, a specific cause for the ¿bending¿ out of portal and device occlusion could not be established with the available information, including imaging evaluation.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.

• Brand Name: REDUCED PROFILE GORE® VIABAHN® VBX 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: 24942357
• Report Number: 2017233-2026-07406
• Device Sequence Number: 8936180
• Product Code: PRL
• UDI-Device Identifier: 00733132658763
• UDI-Public: (01)00733132658763(17)280306
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: BXB087902A
• 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: 03/29/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2025
• 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: 73 YR
• Patient Sex: Male