GORE VIABAHN VBX Balloon Expandable Endo BXA085901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132637324), received between Jul 13, 2018 and Feb 8, 2024 — classified as 2 deaths, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathFeb 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT PRESENTED FOR BILATERAL TREATMENT IN THE ILIAC ARTERIES DUE TO OCCLUSIVE DISEASE. AS REPORTED, THE PATIENT ALSO HAD CALCIFIED ARTERIES. IN THE COMMON FEMORAL ARTERIES, 8FR CORDIS BRITE TIP SHEATHS WERE PLACED AND TARGET LESIONS WERE PRE-DILATED. OVER AN .035 WIRE, AN 8 X 29 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/BALLOON) WAS ADVANCED AND PLACED IN THE RIGHT COMMON ILIAC ARTERY. AN 8 X 79 VBX DEVICE WAS ALSO ADVANCED OVER AN .035 WIRE TO THE LEFT COMMON ILIAC ARTERY. USING A KISSING TECHNIQUE, BOTH VBX DEVICES WERE DEPLOYED. WHEN THE VBX BALLOONS WERE DEFLATED, IT WAS REALIZED THE LEFT EXTERNAL ILIAC ARTERY HAD RUPTURED DISTAL TO THE 8 X 79 VBX DEVICE. THE BLEEDING WAS CONTROLLED TEMPORARILY BY RE-INFLATING THE VBX BALLOON. AIMING TO CONTROL THE BLEEDING FROM THE RIGHT SIDE, THE PHYSICIAN EXCHANGED THE 8FR CORDIS BRITE TIP SHEATH FOR A 9FR SHEATH (BRAND UNKNOWN) TO ACCOMMODATE A CODA® BALLOON CATHETER (CODA BALLOON). HOWEVER, THE CODA BALLOON DID NOT FIT THROUGH THE 9FR SHEATH. THE 9FR SHEATH WAS UPSIZED TO A 10FR SHEATH (UNKNOWN BRAND), BUT THE CODA BALLOON STILL DID NOT FIT THROUGH THE 10FR SHE

  Patient problems: Perforation of Vessels

  MAUDE report 18668269 ↗
• MalfunctionFeb 25, 2021Material Rupture; Material Rupture

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT WITH BILATERAL ILIAC OCCLUSIONS AND UNDERWENT TREATMENT UTILIZING TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES. THE PHYSICIAN ADVANCED BOTH VBX DEVICES TO THE TREATMENT ZONE AND INITIATED DEPLOYMENT. ONE VBX DEVICE ((B)(4)) WAS DEPLOYED WITHOUT ISSUE. THE SECOND ENDOPROSTHESIS' ((B)(4)) BALLOON RUPTURED AT NOMINAL PRESSURE BUT COMPLETE DEPLOYMENT WAS SUCCESSFUL. THE RUPTURED BALLOON WAS WITHDRAWN WITHOUT ISSUE AND ANOTHER BALLOON WAS USED FOR POST DILATION. SINCE BOTH VBX DEVICES WERE DEPLOYED AT THE SAME TIME AND ARE IDENTICAL IN SIZE, IT IS UNKNOWN WHICH VBX DEVICE IS ASSOCIATED WITH THE BALLOON RUPTURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11381977 ↗
• MalfunctionNov 12, 2020Deflation Problem; Deflation Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON AN UNKNOWN DATE IN (B)(6) 2020, THE PATIENT PRESENTED WITH AN UNKNOWN ETIOLOGY IN THE LEFT ILIAC ARTERY AND UNDERWENT TREATMENT USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX). THE PHYSICIAN ADVANCED THE VBX DEVICE TO THE TREATMENT ZONE AND DEPLOYED THE ENDOPROSTHESIS. UPON SUCCESSFUL DEPLOYMENT, ATTEMPTS WERE MADE TO DEFLATE THE BALLOON BUT WERE UNSUCCESSFUL AND CONFIRMED BY OBSERVATION OF CONTRAST. THE PHYSICIAN THEN USED A NEW INDEFLATOR AND SYRINGES TO ATTEMPT DEFLATION, BUT WERE ALSO UNSUCCESSFUL. THE PHYSICIAN CONTINUED DEFLATION ATTEMPTS FOR AN EXTENDED PERIOD OF TIME UNTIL A SECONDARY PHYSICIAN COULD ASSIST. THE PHYSICIANS THEN USED A WIRE TO POP THE VBX BALLOON AND COMPLETED THE PROCEDURE. REPORTEDLY, THERE WERE NO OBSERVABLE KINKS IN THE BALLOON LINE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10833069 ↗
• MalfunctionJul 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO GORE ON (B)(6) 2020 A PROCEDURE WAS BEING PERFORMED USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE PHYSICIAN REPORTED THE PATIENT HAD TORTUOUS ANATOMY WHICH HE BELIEVES CAUSED THE STENT TO FALL OFF THE BALLOON. HE THEN TRIED ANOTHER VBX OF THE SAME SIZE AND THAT STENT CAME OFF THE BALLOON AS WELL. PATIENT DISPOSITION IS UNKNOWN AT THIS TIME. THIS MEDWATCH REPORT IS FOR THE 2ND REPORTED DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10247886 ↗
• MalfunctionMay 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED FOR AORTIC BIFURCATION TREATMENT. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WAS ADVANCED INTO THE LEFT COMMON ILIAC FOR BILATERAL KISSING TREATMENT. THE BALLOON WAS INFLATED AND THE VBX SUCCESSFULLY EXPANDED IN THE CORRECT POSITION. HOWEVER, THE DOCTOR WAS UNABLE TO DEFLATE THE BALLOON. THE DOCTOR TRIED PULLING NEGATIVE PRESSURE WITH A LARGE SYRINGE AND THEN TRIED TO POP THE BALLOON WITH EXCESSIVE PRESSURE. BOTH ATTEMPTS WERE UNSUCCESSFUL. THE DOCTOR EVENTUALLY USED A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC (TIPS) LANCET NEEDLE TO GET THE CATHETER/BALLOON OUT. THERE WAS NO HARM DONE TO THE PATIENT.

  Patient problems: Occlusion

  MAUDE report 10081141 ↗
• DeathJul 13, 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 WITH A THORACIC AORTIC ANEURYSM AND TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED WITH NO ISSUES. WHILE RETRACTING A 24FR GORE® DRYSEAL FLEX INTRODUCER SHEATH THE RIGHT COMMON FEMORAL ARTERY WAS PERFORATED. THE PATIENT BECAME UNSTABLE DUE TO BLOOD PRESSURE DROP. A CODA BALLOON WAS ADVANCED TO OCCLUDE THE ARTERY AND A BUDDY WIRE WAS UTILIZED TO DEPLOY TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES IN ORDER TO COVER THE PERFORATED ARTERY. THE PHYSICIAN NOTICED UNDER ANGIOGRAPHY THE BUDDY WIRE HAD GONE THROUGH THE FALSE LUMEN AND THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE IMPLANTED IN THE FALSE LUMEN. ATTEMPTS WERE MADE TO GAIN ACCESS FROM THE LEFT COMMON FEMORAL ARTERY. THE PLAN WAS TO CRUSH THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES IN ORDER TO RE-OPEN THE TRUE LUMEN. HOWEVER, THE GUIDEWIRE COULD NOT BE ADVANCED BEYOND THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES. THE PATIENT HEMORRHAGED DURING THESE ATTEMPTS AND APPROXIMATELY TEN UNITS OF BLOOD WERE ADMINISTERED. THE PHYSICIAN WAS UNABLE TO GAIN ACCESS TO THE TRUE LUMEN. THE PATIENT EXPI

  Patient problems: Death

  MAUDE report 7688301 ↗

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