GORE VIABAHN VBX Balloon Expandable Endo BXA082901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132637546), received between Feb 4, 2019 and Jul 9, 2021 — classified as 2 deaths, 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE VIA USER FACILITY MDR: ON (B)(6) 2021, WHILE PLACING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE), THE VBX DEVICE BECAME TRAPPED IN THE STENOSIS OF THE SUPERIOR MESENTERIC ARTERY. AS REPORTED, THE VBX DEVICE DISLODGED FROM THE DELIVERY SYSTEM AND ATTEMPTS WERE MADE TO RE-POSITION THE VBX DEVICE WITH A PARTIALLY INFLATED BALLOON. AFTER THE VBX DEVICE WAS SNARED, IT COULD NOT BE RE-POSITIONED TO THE INTENDED TREATMENT AREA WITHOUT CAUSING SIGNIFICANT ARTERIAL INJURY. AS A RESULT, THE VBX DEVICE WAS REMOVED THROUGH OPEN PROCEDURE. ACCESS WAS MADE FROM RIGHT COMMON FEMORAL ARTERY USING ULTRASOUND GUIDANCE. AFTER A MICROPUNCTURE SET, UPSIZING TO 6 FRENCH SHEATH WAS DONE. AN OMNIFLUSH CATHETER WAS ADVANCED INTO THE AORTA AND AN AORTOGRAM WAS OBTAINED. THE SHEATH WAS EXCHANGED FOR A 45CM 7FR CONFORMABLE SHEATH WHICH WAS ADVANCED TO THE PARAVISCERAL AORTA. WITH THIS SHEATH AND A BERN CATHETER, THE CELIAC ARTERY WAS ACCESSED. A 7X22MM ICAST STENT WAS PUT INTO POSITION AT THE ORIGIN AND DEPLOYED. THE PROXIMAL END WAS FLARED IN THE AORTA WITH A 9MM BALLOON. ANGIOGRAM SHOWED GOOD RESULT AT THIS LOCATION. THE SHEATH WAS WITHDRAWN BACK IN

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12143874 ↗
• InjuryMar 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, PATIENT PRESENTED FOR TREATMENT OF OCCLUSIVE COMMON ILIAC ARTERIES. ACCESS WAS BILATERAL FEMORAL ARTERIES AND A KISSING STENT TECHNIQUE WAS USED AT THE BIFURCATION. BOTH OF THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX DEVICE) REACHED THE TARGET TREATMENT AREA AND DEPLOYED WITH NO ISSUES. HOWEVER, AFTER DEVICE EXPANSION ONE BALLOON COULD NOT BE DEFLATED. THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON BY OVER-INFLATION IN ORDER TO BURST THE BALLOON, AND ALSO USING A TIPS/SEPTAL NEEDLE TO PUNCTURE THE BALLOON. DURING USE OF NEEDLE, AN ARTERY WAS PUNCTURED, CREATING A PERFORATION. A GORE® VIABAHN® ENDOPROSTHESIS WAS USED TO COVER THE PERFORATION. AS BALLOON REMAINED INFLATED, A RETROPERITONEAL EXPOSURE OF THE ILIAC ARTERY WAS NECESSARY TO DEFLATE THE BALLOON. THE DEFLATED BALLOON WAS THEN COVERED WITH A STENT. THE BALLOON REMAINED IN THE PATIENT DUE TO HEMODYNAMIC INSTABILITY. THE BROKEN CATHETER WAS REMOVED FROM THE PATIENT. AS REPORTED, THE BALLOON REMAINED ATTACHED TO CATHETER DURING ATTEMPTS TO DEFLATE, THERE WERE NO PRE-EXISTING STENTS, AND A HYBRID APPROACH WAS USED. IT WAS ALSO REPORTED THE PATIENT CODED TWO TI

  Patient problems: Foreign Body In Patient

  MAUDE report 11467570 ↗
• DeathMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A SYMPTOMATIC ABDOMINAL AORTIC ANEURYSM WITH SHORT DISTANCE CLAUDICATION OF BOTH LOWER EXTREMITIES AND BILATERAL ILIAC ARTERY OCCLUSIONS; WITH COMPLETE OCCLUSION OF THE RIGHT EXTERNAL ILIAC ARTERY (RCIA) AND LEFT COMMON ILIAC ARTERY (LCIA). POST DISSECTION OF THE BILATERAL CIA¿S A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT GRAFT) WAS ADVANCED AND DEPLOYED WITHIN THE RCIA AND EXTENDED WITH A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE DOWN TO THE REIA AND INFLATED TO 12MMHG. A 16 FR SHEATH WAS THEN ADVANCED THROUGH THE RIGHT ILIAC VIABAHN® SYSTEM AND A GORE® EXCLUDER® TRUNK IPSILATERAL LEG COMPONENT FEATURING C3® DELIVERY SYSTEM WAS ADVANCED AND DEPLOYED JUST DISTAL TO THE RENAL ARTERIES. A SECOND TRUNK IPSILATERAL LEG COMPONENT OF THE SAME SIZE WAS THEN ADVANCED AND DEPLOYED TO OVERLAP THE FIRST ONE. ANGIOPLASTY OF THE ENTIRE SYSTEM WAS PERFORMED ALL THE WAY DOWN TO THE COMMON AND EXTERNAL ILIAC¿S. COMPLETION ANGIOGRAPHY DEMONSTRATED NO ENDOLEAK AND A WIDELY PATENT GRAFT SYSTEM AND A FEMORAL TO FEMORAL ARTERY BYPASS WAS PERFORMED. AN ANGIOGRAPH WAS PERFORMED AND SHOWED TWO AREAS O

  Patient problems: Cardiogenic Shock; Hypovolemic Shock

  MAUDE report 11440247 ↗
• InjuryJun 12, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: PATIENT PRESENTED FOR A FROZEN ELEPHANT TRUNK OPEN PROCEDURE AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG) WAS IMPLANTED. AFTER IMPLANTING THE CTAG DEVICE, THE PHYSICIAN CUT A SMALL HOLE IN THE CTAG DEVICE WITH AN 11 BLADE. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS THEN ADVANCED INTO THE FENESTRATION, AND INTO THE LEFT SUBCLAVIAN ARTERY (LSA). AS REPORTED, THE LSA WAS LOCATED VERY POSTERIOR AND THE LSA WAS DESCRIBED AS TISSUE THIN AND VERY DISEASED. AS THE VBX DEVICE WAS ADVANCED, THE LSA WAS PERFORATED. THE VBX DEVICE WAS REMOVED FROM THE PATIENT AND DISCARDED. THE LSA WAS THEN LIGATED AND A SECOND CTAG DEVICE WAS IMPLANTED TO COVER THE LIGATED ARTERY. THE PHYSICIAN CONCLUDED THAT COLLATERAL VESSELS WOULD CONTINUE TO PERFUSE THE ARTERY. THE PATIENT WAS REPORTED TO BE RECOVERING WELL FOLLOWING THE OPEN PROCEDURE.

  Patient problems: Perforation

  MAUDE report 8692164 ↗
• DeathFeb 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE BY THE DOCTOR: RIGHT CIA CTO CROSSED, 8MM VBX (#18541468, BXA083901A) DEPLOYED WITHOUT POST-DILATION. FEMORO-FEMORAL BYPASS GRAFT PLACED (#6061060, HT064050A). BEFORE LEAVING OR THE FILMS WERE REVIEWED AND SIMULTANEOUSLY, THE PATIENT BECAME HYPOTENSIVE; IT WAS NOTICED THAT ON THE COMPLETION AORTO-ILIAC ANGIOGRAM, THERE WAS A BLUSH FROM THE PROXIMAL EDGE OF THE STENT. A SECOND 8MM VBX (#18832099, BXA082801A) WAS PLACED WITH PROXIMAL OVERLAP EXTENDING INTO THE DISTAL AORTA AND COVERING THE AREA OF EXTRAVASATION. THIS SECOND VBX WAS POST-DILATED WITH A 10X2 BALLOON. THE NEXT COMPLETION AORTO-ILIAC ANGIOGRAM SHOWED NO FURTHER EXTRAVASATION AND THE HYPOTENSION RESOLVED PROMPTLY. THE PATIENT REMAINED STABLE IN THE OPERATING ROOM AND WAS TRANSFERRED TO THE ICU FOR OBSERVATION. SHORTLY AFTER ARRIVAL TO THE ICU, THE PATIENT AGAIN BECAME HYPOTENSIVE AND ARRESTED. THE ABDOMEN WAS NOTED TO BE DISTENDED AND RIGID. RESUSCITATION AND CPR WERE UNSUCCESSFUL AND SHE WAS PRONOUNCED DEAD.

  Patient problems: Death

  MAUDE report 8302196 ↗

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