GORE VIABAHN VBX Balloon Expandable Endo BXA075901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132637287), received between Apr 26, 2023 and Apr 9, 2024 — classified as 1 injury, 1 malfunction.

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.

• InjuryApr 9, 2024Collapse; Obstruction of Flow; Collapse; Obstruction of Flow

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES) WERE IMPLANTED IN THE SUPERIOR MESENTERIC ARTERY (SMA) AND THE RIGHT RENAL ARTERY AS SNORKELS DURING THE PROCEDURE. THE PHYSICIAN REPORTED ON THE EVENING OF (B)(6) 2024, THAT THE VBX STENT GRAFT WAS THROMBOSED. IMMEDIATELY, AN ENDOVASCULAR REINTERVENTION OCCURRED AND REPORTEDLY THE PHYSICIAN WAS UNABLE TO ADVANCE THROUGH THE SMA AND VBX STENT GRAFT. THE PROCEDURE WAS ABORTED, AND THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN SUSPECTED THE VBX DEVICE MAY HAVE THROMBOSED BECAUSE THE EYE OF THE TIGER TECHNIQUE WAS PERFORMED INCORRECTLY, CONSEQUENTLY THE GORE® EXCLUDER® AAA ENDOPROSTHESIS MAY HAVE COMPRESSED THE VBX STENT GRAFT. THE PATIENT WILL CONTINUE TO BE MONITORED. NONE OF THE GORE DEVICES WERE EXPLANTED, AND NO ADDITIONAL GORE DEVICES WERE IMPLANTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19075891 ↗
• MalfunctionApr 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023, THE PATIENT WAS BEING TREATED FOR A STENOTIC LESION IN THE ILIAC ARTERY USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE DEVICE WAS INSERTED SUCCESSFULLY WITH NO ISSUE THROUGH A 7 FR TERUMO SHEATH. THE DEVICE WAS UNABLE TO BE ADVANCED DUE TO STENOSIS. THE VESSEL HAD NOT BEEN DILATED. THE DEVICE WAS ATTEMPTED TO BE WITHDRAWN THROUGH THE SHEATH AND THE STENT GRAFT DETACHED FROM THE DELIVERY SYSTEM CATHETER. THE DEVICE WAS REMOVED WITH A SNARE CATHETER FROM THE PATIENT. THE PATIENTS VESSEL WAS DILATED AND A DIFFERENT GORE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820642 ↗

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