GORE VIABAHN VBX Balloon Expandable Endo BXA063902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132637195), received between Jul 9, 2018 and Oct 30, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2020Material Invagination; Material Invagination

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT PRESENTED WITH OCCLUSION OF THE BILATERAL CAROTID ARTERIES AND UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) AND A CAROTID FILTER. THE PHYSICIAN ADVANCED THE CAROTID FILTER AND THE VBX DEVICE TO THE TREATMENT ZONE AND DEPLOYED THE CAROTID FILTER. THE VBX DEVICE WAS THEN DEPLOYED SUCCESSFULLY. THE REMOVAL OF THE CAROTID FILTER WAS THEN ATTEMPTED AND UNSUCCESSFUL DUE TO THE RETRIEVAL WIRE BEING POSITIONED BETWEEN THE VBX DEVICE AND THE VESSEL WALL. ANOTHER RETRIEVAL OF THE FILTER WAS ATTEMPTED REPORTEDLY USING A LOW-PROFILE BALLOON VERTETRAL QUICK CROSS CATHETER, BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN DECIDED TO GRAB THE FILTER WITH A SNARE BUT COULD NOT PROCEED ANY FURTHER DUE TO THE CAROTID FILTER WIRE REMAINING BETWEEN THE VBX DEVICE AND THE VESSEL WALL. CONTRAST WAS THEN INJECTED AND NO BLOOD FLOW COULD BE OBSERVED IN THE INTERNAL CAROTID ARTERY. THE PHYSICIAN THEN DECIDED TO CONVERT TO A CUT DOWN OF THE TREATMENT ZONE TO COMPLETE THE PROCEDURE. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AT THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 10765541 ↗
• InjurySep 3, 2020Migration; Migration

  ON (B)(6) 2020, THE PATIENT PRESENTED WITH AN UNKNOWN ETIOLOGY IN THE RENAL ARTERY AND UNDERWENT TREATMENT USING A GORE® VIABAHN® ENDOPROSTHESIS (VSX) AND THREE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX). THE PHYSICIAN DEPLOYED THE FIRST VBX DEVICE APPROXIMATELY <1 CM SHALLOW IN THE TREATMENT ZONE. THEN THE PHYSICIAN EXTENDED THE PLACED ENDOPROSTHESIS WITH AN ADDITIONAL VBX DEVICE. THE PHYSICIAN THEN DEPLOYED A VSX DEVICE TO LINE BOTH VBX DEVICES. WHILE ATTEMPTING TO REMOVE THE ROSEN GUIDEWIRE, THE WIRE DISLODGED ALL OF THE STENTS AND PULLED THE VBX & VSX DEVICES OUT OF THE VESSEL. THE PHYSICIAN WAS THEN ABLE TO SNARE ALL THREE DEVICES AND CAPTURE THE DEVICES FOR REMOVAL WITH A LARGE BORE SHEATH. A FEMORAL CUT DOWN WAS THEN USED TO REMOVE ALL SNARED DEVICES FROM PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 10491560 ↗
• InjuryDec 6, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2018, A PATIENT PRESENTED FOR TREATMENT OF AN ANEURYSMAL CELIAC ARTERY. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE IMPLANTED TO COVER THE AREA FROM THE CELIAC ARTERY ORIGIN TO THE BIFURCATION. FIRST, THE SPLENIC ARTERY WAS COILED, THEN A VBX DEVICE WAS DEPLOYED. THE SECOND VBX DEVICES WAS OVERLAPPED WITH THE FIRST ONE, DEVICES WERE BALLOONED PROPERLY. AS REPORTED, THE CASE WENT WELL AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2018, IT WAS FOUND THE VBX DEVICES HAD OCCLUDED. THE PATIENT WAS TAKEN TO SURGERY FOR OPEN REPAIR. A TEAR WAS ALSO FOUND NEAR THE ORIGIN OF THE CELIAC ARTERY. A BYPASS WAS CREATED AND THE VBX DEVICES WERE EXPLANTED AND DISCARDED. THE PATIENT WAS REPORTED TO BE RECOVERING WELL FOLLOWING THE INTERVENTION.

  Patient problems: Occlusion; Perforation of Vessels

  MAUDE report 8139353 ↗
• InjuryJul 9, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE FOLLOWING WAS REPORTED TO GORE: THE DOCTOR WAS ATTEMPTING TO TREAT A STENOSED SMA BUT WAS UNSUCCESSFUL IN CROSSING THE LESION WITH THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. WHILE ATTEMPTING TO WITHDRAW THE SYSTEM BACK INTO THE SHEATH, THE STENT RELEASED FROM THE BALLOON AND WAS OBSERVED TO BE FLOATING ON THE WIRE REQUIRING SURGICAL INTERVENTION TO REPAIR THE DAMAGED ARTERY.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7672324 ↗

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