GORE VIABAHN VBX Balloon Expandable Endo BXA082902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132637553), received between Feb 18, 2021 and Sep 27, 2023 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT OF AN OCCLUDED AND SEVERELY CALCIFIED RIGHT COMMON ILIAC ARTERY IN A PATIENT WHO HAS PERIPHERAL ARTERY DISEASE, ACCESS WAS FROM UP AND OVER THE BIFURCATION. THE TARGET LESION WAS NOT PRE-DILATED. A 7FR X 10CM TERUMO SHEATH WAS USED TO ADVANCE THE 8X29 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) OVER A .035 260 GLIDE ADVANTAGE WIRE. AS REPORTED, IT WAS DIFFICULT TO TRACK THE VBX DEVICE TO THE INTENDED TREATMENT AREA. DECISION WAS MADE TO PULL THE VBX DEVICE BACK INTO THE SHEATH. THE 8X29 VBX STENT WAS DISLODGED FROM THE DELIVERY SYSTEM WHEN THE WIRE WAS BEING EXCHANGED FOR A STIFFER WIRE. A 7X40 STERLING BALLOON WAS INSERTED INTO THE DISLODGED VBX STENT AND THE VBX STENT WAS DEPLOYED IN THE RIGHT COMMON ILIAC ARTERY. AN 8X39 VBX DEVICE WAS ALSO IMPLANTED DISTAL TO THE INITIAL VBX STENT WITH GREAT RESULTS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826067 ↗
• MalfunctionJun 28, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE CELIAC ARTERY DURING A PHYSICIAN-MODIFIED ENDOVASCULAR GRAFT (PMEG) PROCEDURE. AFTER THE VBX DEVICE WAS ADVANCED INTO THE CELIAC ARTERY THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE. HOWEVER, AFTER DEPLOYMENT WAS INITIATED, THE PHYSICIAN WAS ONLY ABLE TO GET THE DEVICE TO 4 ATMOSPHERES AND WAS UNABLE TO COMPLETE FULL EXPANSION. THE DELIVERY CATHETER WAS SUCCESSFULLY REMOVED AND AN 8MM BOSTEN SCIENTIFIC MUSTANG BALLOON DILATATION CATHETER WAS ADVANCED TO COMPLETE FULL EXPANSION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Aneurysm expansion

  MAUDE report 17222152 ↗
• MalfunctionApr 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE RIGHT INNOMINATE ARTERY FOR INNOMINATE ARTERY ATHEROSCLEROSIS. ACCESS WAS GAINED ON THE PATIENT THROUGH THE RIGHT ARM (UNSPECIFIED) AND RIGHT FEMORAL ARTERY. IT WAS NOTED THAT THE PHYSICIAN HAD DIFFICULTY ADVANCING THE VBX DEVICE OVER A TERUMO GLIDEWIRE ADVANTAGE. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE VBX DEVICE INTO A 7FR COOK INTRODUCER SHEATH TO REMOVE THE DEVICE. THE VBX DEVICE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. HOWEVER, DURING RETRACTION OF THE VBX DEVICE DELIVERY SYSTEM THE STENT DISLODGED ON PLAQUE IN THE PATIENT'S ILIAC ARTERY. THE PHYSICIAN SUCCESSFULLY DEPLOYED THE DISLODGED VBX DEVICE INTO THE RIGHT EXTERNAL ILIAC ARTERY BY USING A STANDARD BALLOON. ANOTHER VBX DEVICE WAS SUCCESSFULLY DEPLOYED IN THE INITIAL TREATMENT AREA OF THE INNOMINATE ARTERY WITHOUT DIFFICULTY. THERE WAS NO ADVERSE EVENT OR CONSEQUENCES TO THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16716636 ↗
• MalfunctionNov 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2022, THE PATIENT UNDERWENT TREATMENT IN A CELIAC ARTERY FOR AN UNKNOWN ETIOLOGY USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. IT WAS REPORTED THE PHYSICIAN ACCESSED THE TREATMENT AREA VIA THE FEMORAL ARTERY USING A 7F MEDTRONIC TOURGUIDE STEERABLE SHEATH. THE DEVICE WAS SUCCESSFULLY ADVANCED THROUGH THE SHEATH BUT MET RESISTANCE AT THE OSTIUM OF THE CELIAC ARTERY DUE TO TORTUOUS ANATOMY. THE PHYSICIAN DECIDED TO WITHDRAW THE DEVICE. RESISTANCE WAS NOTED AGAIN AS THEY WERE WITHDRAWING INTO THE SHEATH. THE PHYSICIAN REPORTED USING MORE THAN THE NORMAL AMOUNT OF FORCE ATTEMPTING TO WITHDRAW THE DEVICE BACK THROUGH THE SHEATH DUE TO TORTUOUS ANATOMY AND SHARP ANGLE OF THE SHEATH. AT THIS POINT THE PHYSICIAN REPORTED FEELING A ¿POP.¿ AFTER THE CATHETER WAS REMOVED FROM THE PATIENT IT WAS IDENTIFIED THE STENT GRAFT AND THE BALLOON HAD SEPARATED FROM THE CATHETER. THE PHYSICIAN SUSPECTED THE CAUSE OF THE SEPARATION WAS DUE TO DIFFICULTIES THE DEVICE BACK THROUGH THE SHEATH. THE STENT GRAFT AND BALLOON WERE REMOVED USING A SNARE CATHETER. THE PHYSICIAN DECIDED TO CONCLUDE THE PROCEDURE, AND REATTEMPT TO TREAT THE PATIENT ON A LATER DATE. NO IMPACT TO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827025 ↗
• InjuryMay 19, 2022Complete Blockage; Complete Blockage

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, A THROMBECTOMY WAS PERFORMED PRIOR TO DEVICE PLACEMENT. TREATMENT WAS PERFORMED DUE TO AN ANEURYSM IN THE SUBCLAVIAN ARTERY. A 7FR X 45CM TERUMO SHEATH WAS USED TO ADVANCE A 7X29 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). THE VBX DEVICE WAS IMPLANTED WITH GOOD RESULTS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES DURING THIS TREATMENT. LATER THE SAME DAY, THE PATIENT WAS BROUGHT BACK INTO THE OPERATING ROOM BECAUSE THE 7X29 VBX DEVICE HAD OCCLUDED. INTERVENTION WAS PERFORMED WITH AN 8X29 VBX DEVICE THAT EXTENDED FROM THE FIRST DEVICE AND INTO THE AORTA. COMPLETION ANGIOGRAPHY SHOWED THE VBX DEVICE WAS OPEN WITH GOOD FLOW AT CONCLUSION OF PROCEDURE. POST-OPERATIVELY ON (B)(6) 2022, THE PATIENT EXPERIENCED A RIGHT SIDE, POSTERIOR CIRCULATION STROKE. THE PATIENT HAS MULTIPLE AREAS OF STROKE, ECHO NEGATIVE. THE PHYSICIAN REPORTED THE PATIENT CANNOT MOVE HIS LEFT ARM AND EXHIBITED CONFUSION. THE PATIENT'S MENTAL STATUS HAS SOMEWHAT IMPROVED, ALTHOUGH STILL EXPERIENCING SOME SLURRED SPEECH/DYSARTHRIA AS OF ON (B)(6) 2022. THE PHYSICIAN STATED THAT NOT INITIALLY EXTENDING THE VBX DEVICE INTO THE AORTA M

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 14438443 ↗
• InjuryFeb 11, 2022Separation Problem; Separation Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT TREATMENT OF A STENOTIC LESION IN THE SUBCLAVIAN ARTERY USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE SHEATH ACCESS SITE WAS THE BRACHIAL ARTERY (SIDE UNKNOWN). THE DEVICE MET RESISTANCE WHILE ADVANCING DUE TO STENOSIS. THE PHYSICIAN ATTEMPTED TO WITHDRAWN THE DEVICE THROUGH THE SHEATH. IT WAS NOTED THAT THE DEVICE SEPARATED FROM THE CATHETER DURING THE ATTEMPT TO WITHDRAW THROUGH THE SHEATH. A CUT DOWN WAS PERFORMED TO REMOVED THE DEVICE. ANOTHER GORE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518215 ↗
• MalfunctionJun 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON JUNE 21, 2021, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WAS INTENDED FOR USE IN THE SPLENIC ARTERY TO TREAT AN ANEURYSM. ONCE THE DEVICE WAS IN THE VESSEL THE PHYSICIAN HAD DIFFICULTIES POSITIONING THE DEVICE CORRECTLY. HE HAD TO MOVE THE VBX DEVICE BACK AND FORTH, UNTIL THE DECISION WAS MADE TO RETRACT THE VBX DEVICE. THE PHYSICIAN WAS USING A LOT OF FORCE TO PULL THE VBX DEVICE BACK THROUGH THE INTRODUCER SHEATH. AFTER THE DELIVERY CATHETER WAS REMOVED, HE NOTICED THAT THE VBX DEVICE HAD BECOME DISLODGED IN THE VESSEL. THE PHYSICIAN WAS ABLE TO GET A SMALLER BALLOON (MANUFACTURER UNKNOWN) INTO THE VBX DEVICE AND DEPLOY THE VBX DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. THE PHYSICIAN STATED IT WAS TIGHT GETTING INTO THE VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081110 ↗
• MalfunctionFeb 18, 2021Separation Problem; Separation Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT UNDERWENT TREATMENT FOR STENOSIS IN THE FEMORAL ARTERY. THE KISSING STENT TECHNIQUE USING GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WAS USED FOR THE PROCEDURE. A 7FR DESTINATION SHEATH WAS USED DURING THE PROCEDURE. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS MET RESISTANCE ADVANCING AND WAS NOT ABLE TO ADVANCE THROUGH THE PATIENT¿S CALCIFIED ILIAC. THE DEVICE THEN WAS ATTEMPTED TO BE WITHDRAWN THROUGH THE SHEATH. THE STENT DETACHED FROM THE CATHETER IN THE PATIENT¿S FEMORAL ARTERY. A SNARED GRAFT WAS USED TO RETRIEVE THE DEVICE. TWO ADDITIONAL GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343153 ↗

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