GORE VIABAHN VBX Balloon Expandable Endo BXA055902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132637133), received between Mar 3, 2022 and Mar 7, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Collapse” (1 report).

1 other recall cover devices cleared under the same FDA submission (P160021); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON *(B)(6) 2022, A STUDY PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM IN THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) CLINICAL TRIAL. THE VBX STENTS WERE IMPLANTED AS BRANCH COMPONENTS IN THE CELIAC, SUPERIOR MESENTERIC ARTERY (SMA), LEFT AND RIGHT RENAL ARTERIES. TWO VBX STENTS WERE DEPLOYED IN AN OVERLAPPED FASHION (ONE UNIT) IN THE RIGHT RENAL ARTERY. DURING ANOTHER INTERVENTION ON (B)(6) 2023, CT SCANS PERFORMED PRE PROCEDURE REVEALED A DEFINITIVE AND UNKNOWN III LEAK FROM THE RIGHT RENAL MID VBX STENTS. AS REPORTED, THE PHYSICIAN SUSPECTED THIS WAS DUE TO A GRAFT TEAR OF THE VBX STENT. ON THE SAME DAY, BALLOON ANGIOPLASTY WITH IMPLANT OF A 5MM X 59MM VBX DEVICE WERE COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 16500056 ↗
• InjuryMar 3, 2022Collapse; Collapse

  INFORMATION OBTAINED FROM MEDRIO STUDY DATABASE: FILE NAME: L-CHANGE-REINT_20220201. RECVD: 2/4/2022. SIDE BRANCH (VBX) BXA055902A/ 20315585 USED IN RIGHT RENAL ARTERY (MOST PROXIMAL WITHIN THE PORTAL) SIDE BRANCH (VBX) BXA071902A/21271667 USED IN RIGHT RENAL ARTERY (FIRST DISTAL EXTENSION) SIDE BRANCH (VBX) BXA 053902A/24277912 USED IN RIGHT RENAL ARTERY (MOST PROXIMAL WITHIN THE PORTAL) PROCEDURE DATE: (B)(6) 2019 DR (B)(6). THE UNIVERSITY OF (B)(6). WHITE MALE, DOB (B)(6) 1935, WEIGHT (B)(6). COMORBIDITIES: CORONARY ARTERY BYPASS GRAFT, PERCUTANEOUS CORONARY INTERVENTION, CORONARY ARTERY DISEASE, HYPERCHOLESTEROLEMIA, HYPERTENSION, ATRIAL FIBRILLATION, AND COLORECTAL CANCER. MEDICATIONS: ASPIRIN, WARFARIN, STUDY PT: (B)(6). ADVERSE EVENT - 03 DATE OF ONSET - POSSIBLE RIGHT RENAL ARTERY STENT CRUSHED/SLIGHTLY NARROWED RITYPE: PROCEDURE DONE ON (B)(6) 2022, HAD STENT PLACED (VBX 5 X 39 AND AN ICAST 6 X 38)

  Patient problems: Obstruction/Occlusion

  MAUDE report 13664101 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160021. One submission often covers many models, so check the product and lot details in each record.

• Z-0077-2022 · Sep 7, 2021 · Open, Classified
  Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diame