GORE VIABAHN VBX Balloon Expandable Endo BXA112902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132637706), received between May 24, 2019 and May 6, 2022 — classified as 3 injuries, 3 malfunctions.

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

• InjuryMay 6, 2022Inflation Problem; Malposition of Device; Premature Separation; Inflation Problem; Malposition of Device; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, A PATIENT UNDERWENT TREATMENT FOR THE RIGHT COMMON FEMORAL ARTERY UTILIZING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. IT WAS REPORTED THAT THE TECHNICIAN PREPARED THE DEVICE WITH A SHORT, NEGATIVE PRESSURE ON THE BALLOON AND THEN THE VBX DEVICE WAS ADVANCED TO THE RIGHT COMMON FEMORAL ARTERY FROM THE CONTRA-LATERAL SIDE USING AN 8 FR ANSEL SHEATH. THE PHYSICIAN REPORTED THAT THE VBX DEVICE WAS DIFFICULT TO ADVANCE THROUGH THE SHEATH, ALTHOUGH IT WAS ULTIMATELY ABLE TO BE ADVANCED TO THE INTENDED LOCATION. UPON INFLATION, THE BALLOON ON THE STENT REPORTEDLY INFLATED ON THE PROXIMAL END, BUT NOT THE DISTAL END. THE STENT THEN DISLODGED FROM THE BALLOON CATHETER WITH ENOUGH FORCE TO PUSH IT INTO THE DISTAL THIRD OF THE SUPERFICIAL FEMORAL ARTERY (SFA). AN ATTEMPT WAS MADE TO USE A SEPARATE BALLOON (ARMADA 14MM X 20MM), BUT THE STENT WAS UNABLE TO BE FULLY DEPLOYED. THE PATIENT WAS THE TAKEN TO SURGERY AND AN OPEN CUT-DOWN WAS PERFORMED TO FIX THE LEAK IN THE COMMON FEMORAL ARTERY. A SHEATH AND GUIDEWIRE WERE THEN USED TO ACCESS THE STENT IN TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310177 ↗
• InjuryApr 22, 2021No Flow; No Flow

  'OUTCOMES OF SMALL RENAL ARTERY TARGETS IN PATIENTS TREATED BY FENESTRATED- BRANCHED ENDOVASCULAR AORTIC REPAIR' JUSSI M. KÄRKKÄINEN, EMANUEL R. TENORIO, KEOUNA PATHER, BERNARDO C. MENDES, THANILA A. MACEDO, JEAN WIGHAM, ALISA DIDERRICH, GUSTAVO S. ODERICH. THE AIM WAS TO EVALUATE RENAL RELATED OUTCOMES IN PATIENTS WHO HAD INCORPORATION OF A SMALL (<4.0 MM) RENAL ARTERY (RA) DURING FENESTRATED-BRANCHED ENDOVASCULAR AORTIC REPAIR (F-BEVAR). A TOTAL OF 215 CONSECUTIVE PATIENTS ENROLLED IN A PROSPECTIVE F-BEVAR TRIAL WERE REVIEWED. THE KAPLANE-MEIER ESTIMATES OF ONE AND TWO YEAR RA RELATED OUTCOMES ARE PRESENTED IN TABLE 4. AT ONE YEAR, PRIMARY PATENCY WAS 79 ± 9% IN THE STUDY GROUP AND 94 ± 1% IN THE CONTROL GROUP (P < .001); SECONDARY PATENCY WAS 84 ± 8% VS. 97 ± 1% (P < .001), RESPECTIVELY (FIG. 3A). FREEDOM FROM RA INSTABILITY WAS 79 ± 9% VS. 93 ± 2% AT ONE YEAR (P ¼ .005, FIG. 3B), AND FREEDOM FROM RENAL FUNCTION DETERIORATION WAS 90 ± 7% VS. 90 ± 3% (P ¼ .09), RESPECTIVELY. THERE WERE NO DIFFERENCES IN FREEDOM FROM REINTERVENTION AND SURVIVAL BETWEEN THE GROUPS. NO DEVICE ALLEGATIONS OF DEFICIENCIES SPECIFIC FOR GORE DEVICES.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11709214 ↗
• MalfunctionDec 9, 2020Material Separation; Material Separation

  ON (B)(6) 2020, THE PATIENT WAS UNDERGOING A TRANSCAROTID CUT DOWN FLOW REVERSAL PROCEDURE IN THE INNOMINATE ARTERY USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE DEVICE WAS ADVANCED ANTEGRADE AND DEPLOYED WITH NO ISSUE. AFTER THE SUCCESSFUL DEPLOYMENT, THE CATHETER WAS BEING WITHDRAWN THROUGH THE SHEATH. IT WAS OBSERVED THE BALLOON SEPARATED FROM THE CATHETER. THE BALLOON REMAINED INSIDE THE PORTION OF THE SHEATH THAT WAS LOCATED INSIDE OF THE PATIENT. THE BALLOON WAS WITHDRAWN FROM THE PATIENT ALONG WITH THE SHEATH. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10977163 ↗
• MalfunctionNov 2, 2020Material Separation; Material Separation

  ON (B)(6) 2020, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS(VBX) WAS BEING PLACED AS A INNOMINATE STENT IN CONJUNCTION WITH TRANSCAROTID ARTERY RE-VASCULARIZATION (TCAR) PROCEDURE. DURING THE ADVANCEMENT OF THE DEVICE THE PHYSICIAN HAD TO USE EXCESSIVE FORCE TO GET THE DEVICE INTO PLACE. AFTER THE DEVICE WAS SUCCESSFULLY DEPLOYED, THE PHYSICIAN WAS REMOVING THE DEVICE CATHETER THROUGH THE 8FR TCAR INTRODUCER SHEATH, AND FELT RESISTANCE. AFTER THE RESISTANCE WAS FELT HE CONTINUED TO WITHDRAW THE CATHETER, AND THE CATHETER BROKE. THE PHYSICIAN REMOVED THE REMAINDER OF THE CATHETER AND SHEATH IN TANDEM. WHEN IT WAS REMOVED, IT WAS SUSPECTED THAT THE BALLOON PORTION OF THE CATHETER HUNG UP ON THE SHEATH TIP. PATIENT DID NOT SUFFER ANY ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10775046 ↗
• InjuryDec 3, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2019 A PATIENT WAS UNDERGOING TREATMENT OF A COMMON ILIAC ARTERY STENOTIC LESION WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES. THERE WAS ALSO A DISTAL AORTIC ANEURYSM, BUT IT WAS DECIDED THIS ANEURYSM WOULD NOT BE TREATED AT THIS TIME. FOLLOWING ADVANCEMENT OF BOTH VBX DEVICES IN KISSING TECHNIQUE, THE DEVICES WERE DEPLOYED WITH SIMULTANEOUS BALLOONING, SUCCESSFULLY. THE BALLOONS WERE DEFLATED AND REMOVED. THE ANESTHESIOLOGIST NOTICED A DROP IN THE PATIENT'S BLOOD PRESSURE SO THE BLOOD PRESSURE CUFF WAS CHECKED AND REAPPLIED. HOWEVER THE BLOOD PRESSURE READING REMAINED LOW. A PIGTAIL CATHETER WAS THEN ADVANCED AND AORTIC RUPTURE WAS REALIZED. AN OCCLUSION BALLOON WAS ADVANCED FOR HEMORRHAGE CONTROL AND A COOK MAIN BODY DEVICE WAS IMPLANTED TO TREAT THE AORTIC RUPTURE. THE LEFT LIMB OF THE MAIN BODY WAS TREATED SUCCESSFULLY, PRESERVING THE LEFT ILIAC ARTERY. HOWEVER, THE RIGHT SIDE COULD NOT BE TREATED. THE RIGHT SIDE WAS PLUGGED WITH AN AMPLATZ DEVICE. FOR THIS REASON, A FEMORAL TO FEMORAL ARTERY BYPASS WAS NECESSARY AND THIS WAS CARRIED OUT BY ANOTHER SURGEON. THE PATIENT REQUIRED REPLACEMENT BLOOD PRODUCTS, HOWEVER WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: Aneurysm; Blood Loss

  MAUDE report 9405105 ↗
• MalfunctionMay 24, 2019Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Difficult or Delayed Separation; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Difficult or Delayed Separation

  THE FOLLOWING WAS REPORTED TO THE GORE FSA BY THE DOCTOR: THE PATIENT PRESENTED FOR A FLOW REVERSAL CASE. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS ADVANCED THROUGH THE 8FR SILK ROAD MEDICAL SHEATH AND DEPLOYED AS EXPECTED. AS THE BALLOON WAS BEING WITHDRAWN, IT GOT STUCK IN THE INTRODUCER SHEATH AND CAME OFF THE CATHETER WHEN THE DOCTOR PULLED BACK (AFTER IT WAS STUCK IN THE SHEATH). THE INTRODUCER AND CATHETER WERE REMOVED TOGETHER WITH NO FURTHER INCIDENT. THE PATIENT WAS REPORTED TO BE FINE. THE CATHETER WAS DISCARDED AT THE HOSPITAL.

  Patient problems: Calcium Deposits/Calcification; Occlusion

  MAUDE report 8640991 ↗

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