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

Catalog Number	BXA073902A
Medical Device Problem Codes	Complete Blockage (1094); Biocompatibility (2886)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Renal Impairment (4499)
Date of Event	03/04/2026
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.H6: code c19: review of device manufacturing record history confirmed device met pre-release specifications.H6: code b20: the device remains implanted; therefore, direct product analysis was not possible.Additional manufacturer reports will be submitted for same patient and same procedure/intervention.Report#: 2017233-2026-07289, report#: 2017233-2026-07290.The ifu was reviewed, and the following statement was found to be applicable: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: stenosis, thrombosis or occlusion.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 was reported to gore: on (b)(6) 2024, a patient underwent a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) procedure.During this procedure, several gore® viabahn® vbx balloon expandable endoprosthesis (vbx devices) were implanted in the visceral arteries as branch devices.On (b)(6) 2026, the patient developed abdominal pain that progressively worsened and was accompanied by coffee-ground emesis.On (b)(6) 2026, a repeat cta showed interval occlusion due to vbx stent thrombosis of the celiac, right and left renal arteries.The vbx stent in the sma remained patent as the sole mesenteric inflow.Laboratory results on this date showed elevated bun (59 mg/dl) and creatinine (3.09 mg/dl).Based on the cta findings and the severity of his abdominal pain, the patient was taken emergently for endovascular thrombectomy of the celiac and renal vbx devices, including thrombus clearance from the associated tambe renal and celiac portals.On (b)(6) 2026, according to the physician, the patient was noted to have loss of kidney function following the procedure.Additionally, the treating physician reported the presence of an active gastric ulcer with hematemesis and expressed clinical judgment that hypotension related to gastrointestinal bleeding may have contributed to thrombus formation within the renal and celiac vessels/portals.It is reported that the patient currently remains on dialysis, with bilateral functional impact.
Additional Manufacturer Narrative
H6 - code h was updated.

• 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: 24682394
• Report Number: 2017233-2026-07291
• Device Sequence Number: 13174897
• Product Code: PRL
• UDI-Device Identifier: 00733132637270
• UDI-Public: (01)00733132637270(17)260223
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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 Expiration Date: 02/23/2026
• Device Catalogue Number: BXA073902A
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2023
• 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: 69 YR
• Patient Sex: Male