GORE VIABAHN VBX Balloon Expandable Endo BXA065901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132637201), received between Jul 13, 2021 and Sep 13, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• MalfunctionSep 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2023, PATIENT PRESENTED FOR TREATMENT IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) DUE TO REST PAIN AND ACUTE ISCHEMIA. ACCESS WAS MADE FROM THE CONTRALATERAL FEMORAL ARTERY. THROUGH A 7FR SHEATH (UNSPECIFIED BRAND), A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INSERTED AND IT REACHED INTENDED TREATMENT AREA AND WAS DEPLOYED WITH NO ISSUES. SALINE 70% AND DYE 30% WERE USED TO INFLATE THE BALLOON. AFTER DEVICE DEPLOYMENT, THE PHYSICIAN WAS UNABLE TO GET THE BALLOON TO DEFLATE. IN ORDER TO GET THE BALLOON DELATED, A LARGER SHEATH WAS ADVANCED AND ASPIRATING ON A SMALL SYRINGE FORCED THE BALLOON TO DEFLATE. THE BALLOON WAS THEN PULLED INTO THE SHEATH AND REMOVED WITH THE SHEATH. ONCE THE VBX BALLOON WAS REMOVED, THE PATIENT'S PROFUNDA WAS NOTED TO HAVE A SUSPECTED PLAQUE SHIFT/FLAP. THE PHYSICIAN IMPLANTED A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE IN THE SFA AND A DRUG COATED BALLOON (DCB) WAS USED IN THE PATIENT'S PROFUNDA. POST OPERATIVE, THE PATIENT'S PT/DP PULSES WAS PALPABLE. AS REPORTED, THE REMOVAL OF THE DELIVERY CATHETER THROUGH THE SHEATH REQUIRED SOME FORCE. CONSEQUENTLY, THE DELIVERY CATHETER WAS STRETCHED IN A FEW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17740782 ↗
• InjuryJul 13, 2021Positioning Failure; Positioning Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS(S) (VBX DEVICE) WERE INTENDED FOR USE IN THE RIGHT AND LEFT COMMON ILIAC. THE LEFT ILIAC WAS SUCCESSFULLY TREATED WITH A VBX DEVICE. A VBX DEVICE WAS SUCCESSFULLY DEPLOYED IN THE RIGHT ILIAC. HOWEVER, AN ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT WAS PLACED AS AN EXTENSION, DUE TO A SUSPECTED DISSECTION. UPON A FINAL ANGIOGRAPH, IT WAS NOTICED THAT THE VESSEL HAD LOW FLOW. IT WAS THEN CONFIRMED THAT THE DEVICES WERE PLACED IN A FALSE LUMEN. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM WHERE A SURGICAL CONVERSION WAS COMPLETED WITH A FEM-FEM BYPASS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. THE PHYSICIAN SUSPECTED THAT THE DISSECTION OCCURRED DURING THE ADVANCEMENT OF THE WIRE IN THE DISEASED VESSEL.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12163485 ↗

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