GORE VIABAHN VBX Balloon Expandable Endo BXA072902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132637515), received between Mar 21, 2019 and Mar 5, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: PATIENT PRESENTED FOR ENDOVASCULAR TREATMENT IN THE SUPERIOR MESENTERIC ARTERY (SMA) DUE TO A HIGH-GRADE STENOSIS AND ISCHEMIC SYMPTOMS. DURING TREATMENT, 7FR TOURGUIDE SHEATH AND A 260CM .035 ADVANTAGE GLIDEWIRE WERE USED TO ADVANCE A 7MM X 29MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT). WHILE ATTEMPTING TO TRACK THE VBX DEVICE THROUGH A VERY STEEP AND CURVED VESSEL INTO THE SMA, THE DELIVERY CATHETER WAS PUSHED AND PULLED MULTIPLE TIMES. ATTEMPTS TO GET THE VBX DEVICE INTO THE SMA OSTIUM WAS UNSUCCESSFUL. CONSEQUENTLY, THE VBX DEVICE WAS BEING BACK OUT THROUGH THE SHEATH WHEN THE CONSTRAINED VBX DEVICE CAUGHT ON THE EDGE OF THE SHEATH. THE CONSTRAINED VBX STENT WAS DISLODGED FROM THE DELIVERY CATHETER. BALLOONS OF VARIOUS SIZES AND BRANDS AND DIFFERENT WIRES WERE USED TO PULL THE VBX STENT INTO THE RIGHT EXTERNAL ILIAC ARTERY AND THE DEVICE WAS DEPLOYED AT THAT LOCATION. OVER AN .035 ROSEN WIRE, A NEW VBX DEVICE (6MM X 29MM) WAS IMPLANTED IN THE SMA WITHOUT ANY ISSUES. AS REPORTED, THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837776 ↗
• MalfunctionNov 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  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 ILIAC ARTERY DURING TREATMENT OF A SEVERELY CALCIFIED ARTERY. DURING THE ADVANCEMENT OF THE INTRODUCER SHEATH (MANUFACTURER AND SIZE UNKNOWN), IT HAD BECOME STUCK AND WOULD NOT ADVANCE THROUGH THE SEVERELY CALCIFIED LESION. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE VBX DEVICE THROUGH THE CALCIFIED LESION AND IT HAD BECOME STUCK. DURING THE ADVANCEMENT OF THE VBX DEVICE, IT APPEARED TO BE DISLODGING FROM THE DELIVERY CATHETER. WITH SOME MANIPULATION, THE PHYSICIAN WAS ABLE TO GET THE VBX DEVICE BACK INTO THE INTRODUCER SHEATH AND REMOVE THEM IN TANDEM. THE PHYSICIAN ADVANCED A NEW INTRODUCER SHEATH (MANUFACTURER AND SIZE UNKNOWN) AND PERFORMED AN ANGIOPLASTY. A NEW VBX DEVICE (SAME SIZE) WAS IMPLANTED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088154 ↗
• MalfunctionMay 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  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 FENESTRATED ENDOVASCULAR AORTIC REPAIR. ACCESS WAS GAINED THROUGH THE SUPERFICIAL FEMORAL ARTERY. AFTER THE VBX DEVICE WAS ADVANCED THROUGH AN 8.5 FRENCH OSCOR DEFLECTABLE TIP SHEATH, OVER A 0.035" TAD II GUIDEWIRE, THERE WERE DIFFICULTIES INSERTING THE VBX DEVICE ALL THE WAY THROUGH THE GATE OF THE BRANCH. THE PHYSICIAN THEN ATTEMPTED TO WITHDRAWAL THE VBX DEVICE THROUGH THE INTRODUCER SHEATH. HOWEVER, THE PROXIMAL END OF THE VBX DEVICE HAD BECOME STUCK ON THE INTRODUCER SHEATH AND DISLODGED FROM THE DELIVERY CATHETER. THE VBX DEVICE WAS SUBSEQUENTLY BALLOONED, AND DEPLOYED, PARTIALLY IN THE BRANCH, WITH NO PATIENT DEFECTS. AN ADDITIONAL VBX DEVICE WAS SUCCESSFULLY DEPLOYED IN THE CELIAC ARTERY TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Aneurysm expansion

  MAUDE report 16887833 ↗
• InjuryJul 26, 2022Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022 A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A COOK EVAR DEVICE IN COMBINATION WITH THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WITHIN THE LEFT AND RIGHT RENAL ARTERIES AS WELL AS THE SUPERIOR MESENTERIC ARTERY. DURING THE INDEX PROCEDURE, THROMBOSIS WAS IDENTIFIED WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. ADDITIONALLY, IT WAS STATED THAT PHYSICIAN IDENTIFIED THROMBOSIS IN SEVERAL VESSELS THROUGHOUT THE BODY (VESSELS UNKNOWN). THE PATIENT TOLERATED THE PROCEDURE. ON THE SAME DAY, POST PROCEDURE, THE PHYSICIAN STATED THAT BOWEL NECROSIS WAS OBSERVED DUE TOO THROMBOSIS. THE PHYSICIAN STATED THE PATIENT WILL BE MONITORED. ON (B)(6) 2022 THE PATIENT EXPIRED. IT WAS STATED BY THE PHYSICIAN THAT THERE WAS OCCLUSION OBSERVED WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES. THE PHYSICIAN STATED THERE IS NO ALLEGATION OF DEVICE DEFICIENCY NOR IS THERE A DIRECT LINK BETWEEN THE DEATH OF PATIENT AND THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. (B)(4).

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 15103273 ↗
• MalfunctionMar 28, 2022Malposition of Device; Premature Separation; Malposition of Device; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, A PATIENT PRESENTED WITH STENOSIS IN A SUBCLAVIAN ARTERY AND UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE. WHILE ADVANCING THE VBX DEVICE THROUGH A STENOSED AXILLARY ARTERY, THE STENT DISLODGED FROM THE BALLOON. THOUGH IT WAS NOT THE INTENDED LOCATION, THE PHYSICIAN WAS ABLE TO BALLOON THE VBX DEVICE TO SUCCESSFULLY COVER A STENOTIC LESION WHERE IT DISLODGED. ANOTHER GORE DEVICE WAS USED TO COVER THE ORIGINALLY INTENDED LESION. THE PATIENT TOLERATED THE PROCEDURE WITH NO ADVERSE IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929546 ↗
• MalfunctionDec 18, 2020Material Separation; Material Separation

  ON (B)(6) 2020, THE PATIENT WAS BEING TREATED FOR STENOSIS IN THE ILIAC ARTERY USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. IT WAS REPORTED THE STENT GRAFT SEPARATED FROM THE CATHETER WHILE BEING ADVANCED THROUGH THE PATIENT ILIAC ARTERY. THE PHYSICIAN STATED THE CAUSE WAS THE ANATOMY WAS HEAVILY CALCIFICATION. A SNARE CATHETER WAS USED TO REMOVE THE FULLY CONSTRAINED STENT THROUGH THE SHEATH. ANOTHER GORE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11039624 ↗
• MalfunctionMar 21, 2019Premature Separation; Premature Separation

  THE FOLLOWING WAS REPORTED BY THE FSA: THE PHYSICIAN WAS ATTEMPTING TO DELIVER THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS OVER A ROSEN WIRE INTO THE CELIAC ARTERY USING A TOUR GUIDE STEERABLE SHEATH(GROIN APPROACH). THE TOUR GUIDE KICKED OUT OF THE CELIAC ARTERY AND THE PHYSICIAN COULD NOT GET THE TOUR GUIDE BACK INTO THE CELIAC ARTERY. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS ADVANCED BACK AND FORTH TRYING TO GET INTO THE CELIAC ARTERY BUT IT KEPT HITTING THE COOK FENESTRATED AAA GRAFT. THEN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WENT INTO THE CELIAC ARTERY BUT IT CAME OFF THE CATHETER DURING MANIPULATION. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS NOW HALFWAY IN THE CELIAC ARTERY AND THE AORTA. THE PHYSICIAN USED A SNARE TO CAPTURE AND REMOVED THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WITHOUT ANY CONSEQUENCE TO THE PATIENT.

  Patient problems: Aneurysm

  MAUDE report 8440211 ↗

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