GORE VIABAHN VBX Balloon Expandable Endo BXAL083902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132637829), received between Feb 4, 2019 and May 21, 2022 — classified as 1 death, 2 injuries, 4 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.

• InjuryMay 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, AN ENDOVASCULAR TREATMENT WAS PERFORMED IN THE PATIENT'S LEFT COMMON ILIAC ARTERY DUE TO BILATERAL ILIAC CALCIFICATION AND PERIPHERAL ARTERY DISEASE. A 7FR TERUMO PINNACLE SHEATH WAS USED TO ADVANCE AN 8MM X 39MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) OVER A .035 GLIDEWIRE ADVANTAGE. WHEN THE VBX DEVICE REACHED THE INTENDED TREATMENT SITE, IT WAS REALIZED THE DEVICE WAS TOO LONG. THE PHYSICIAN OPTED TO REMOVE THE VBX DEVICE. HOWEVER, AS THE VBX DEVICE WAS PULLED BACK, THE VBX STENT DISLODGED FROM THE BALLOON CATHETER IN THE LEFT EXTERNAL ILIAC ARTERY. A GROIN CUTDOWN WAS PERFORMED TO RETRIEVE THE DISLODGED VBX STENT VIA AN ARTERIOTOMY IN THE LEFT FEMORAL ARTERY. THE INTACT STENT WAS RETRIEVED AND THE ARTERY WAS CLOSED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14466091 ↗
• DeathNov 4, 2021Human-Device Interface Problem; Human-Device Interface Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A FEMALE PATIENT REQUIRED TREATMENT DUE TO AORTO-ILIAC DISEASE. AS REPORTED, THE PATIENT'S VESSELS WERE CALCIFIED. A COVERED ENDOVASCULAR RECONSTRUCTION OF AORTIC BIFURCATION (CERAB) PROCEDURE WAS PERFORMED USING MULTIPLE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX DEVICES). THE FIRST VBX DEVICE (11X59) WAS PLACED IN THE AORTA AND POST DILATED TO 16MM IN THE PROXIMAL SECTION. NEXT, TWO VBX DEVICES (8L X 39) WERE INSERTED AND DEPLOYED USING A KISSING TECHNIQUE CONFIGURATION INTO THE ILIAC ARTERIES. TWO VBX DEVICES (8X39) WERE ALSO IMPLANTED AT THE OVERLAP. IMAGES REVIEWED SHOWED GOOD RESULTS. USING THE IVUS, IT WAS OBSERVED THE RIGHT SIDE WAS NOT FULLY EXPANDED. TWO 10MM BALLOONS WERE PLACED INTO THE ILIAC ARTERIES THAT HAD THE 8LX39 VBX DEVICES. IMAGES REVEALED ON THE LEFT SIDE, PIECE OF CALCIUM APPEARED TO HAVE PUSHED THROUGH THE LEFT COMMON ILIAC VBX DEVICE AS BLEEDING WAS COMING THROUGH THE STENT. ADDITIONAL VBX DEVICES (8LMM X 79MM) WERE DEPLOYED TO RELINE THE VBX DEVICES. THE PATIENT¿S CONDITION WAS STABILIZED AND WAS TRANSFERRED TO SURGERY. DURING THE SURGICAL CONVERSION, IT WAS FOUND THE PATIENT HAD MORE ISSUE

  Patient problems: Calcium Deposits/Calcification; Perforation of Vessels

  MAUDE report 12754232 ↗
• MalfunctionJan 2, 2020Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: THE PROCEDURE REQUIRED AN ADDITIONAL GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) TO TREAT THE CONTRA LATERAL ILIAC. THE DOCTOR ADVANCED THE SHEATH UP AND OVER WITH A TIGHT AORTIC BIFURCATION. THE 8X39 VBX WAS ADVANCED THROUGH THE 8FR TERUMO SHEATH WITH DIFFICULTY. WHEN THE DEVICE STOPPED ADVANCING THE DOCTOR DECIDED TO REMOVE THE DEVICE. THE DOCTOR REPORTED THAT HE PULLED THE SHEATH BACK AND ATTEMPTED TO PULL THE DEVICE BACK INTO THE SHEATH. THE DEVICE DISLODGED FROM THE CATHETER ON THE IPSILATERAL SIDE BUT WAS STILL ON THE WIRE. THE DOCTOR RAN A 4MM BALLOON INTO THE DEVICE AND DEPLOYED IT IN THE IPSILATERAL ILIAC. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Information

  MAUDE report 9540124 ↗
• MalfunctionDec 12, 2019Detachment of Device or Device Component

  AN ELDERLY MALE PATIENT WITH HYPERTENSION (HTN), HYPERCHOLESTEROLEMIA, DISABLING CLAUDICATION, PERIPHERAL ARTERIAL DISEASE, REST PAIN AND AORTOILIAC OCCLUSIVE DISEASE. ADMITTED FOR STENTING OF LEFT (L) EXTERNAL ILIC ARTERY AS WELL AS THE DISTAL L COMMON ILIAC ARTERY, ANGIOPLASTY OF L COMMON FEMORAL AND RIGHT (R) COMMON FEMORAL ARTERY. PROBLEM: "VBX STENT IS SUPPOSE TO GO THROUGH 7 F SHEATH AND WAS UNABLE TO PASS THROUGH THE 7F" STENT WAS REMOVED IN ENTIRETY.

  Patient problems: Failure of Implant

  MAUDE report 9458214 ↗
• InjuryAug 11, 2019Positioning Failure; Positioning Failure

  ON (B)(6) 2019 A PATIENT WAS UNDERGOING TREATMENT OF BILATERAL ILIAC LESIONS WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES. THE FIRST DEVICE WAS ADVANCED THROUGH A 7FR CORDIS BRITE TIP SHORT SHEATH (13CM). THE VBX WAS ATTEMPTED TO BE ADVANCED BEYOND THE SHORT SHEATH, BUT IT COULD NOT CROSS THE LESION DUE TO TIGHT ANATOMY. THE DEVICE WAS REMOVED THROUGH THE SHORT SHEATH AND PLACED ON THE BACK TABLE. THEN THE LESION WAS BALLOONED. THIS DEVICE WAS ATTEMPTED TO BE REINSERTED, BUT THE STENT CAME OFF THE BALLOON CATHETER. THE STENT WAS PARTIALLY STUCK IN THE INTRODUCER SHEATH. AS THE DEVICE AND SHEATH WERE BEING REMOVED THE EXPOSED PART OF THE STENT WAS STUCK IN THE SUBCUTANEOUS TISSUE OF THE ACCESS SITE. THIS RESULTED IN A CUTDOWN PROCEDURE TO REMOVE THE STENT FROM THE SUBCUTANEOUS TISSUE. ANOTHER VBX DEVICE WAS BEING PREPPED FOR USE, HOWEVER WHEN THE DEVICE WAS BEING FLUSHED, FLUID CAME OUT OF THE BALLOON INFLATION PORT, CAUSING THE DEVICE TO DEPLOY. THE PHYSICIAN DID NOT OBSERVE HOW THE TECHNICIAN WAS PREPORING THE DEVICE FOR USE SO IT CANNOT BE CONFIRMED THAT THE CORRECT PORT WAS UTILIZED. THIS DEVICE WAS NOT USED. THE SHEATH WAS UPSIZED TO A LONGER 8FR SHEATH AND TWO 7

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8881825 ↗
• MalfunctionApr 2, 2019Premature Separation; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS CAME OFF OF THE BALLOON CATHETER IN THE COMMON ILIAC DURING ATTEMPTED REMOVAL TO RE-BALLOON THE TARGETED AREA (LEFT ILIAC). THE DOCTOR REPORTED THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 8474669 ↗
• MalfunctionFeb 4, 2019Material Separation; Material Separation

  THE FOLLOWING WAS REPORTED TO GORE: THE DOCTOR ATTEMPTED TO ADVANCE THE 8MM X 39MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS THROUGH A PREVIOUSLY PLACED 8MM X 29MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS AND THEN UP AN OVER THE BIFURCATION. AS THE DOCTOR WAS MANIPULATING THE DEVICE (PUSHING AND PULLING) ATTEMPTING TO ADVANCE THE DEVICE, HE OBSERVED THE STENT HAD BECOME DISLODGED FROM THE CATHETER. THE STENT WAS ON THE WIRE SO THE DOCTOR ADVANCED A BALLOON INTO THE STENT AND INFLATED IT. WHILE INFLATED THE DOCTOR PULLED THE STENT BACK TO OVERLAP THE PREVIOUSLY IMPLANTED 8MM X 29MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS AND EXTEND THE PREVIOUS COVERAGE. THE DOCTOR THEN TOOK ANOTHER 8MM X 39MM AND SUCCESSFULLY ADVANCED IT TO THE TARGET AREA AND DEPLOYED IT WITH NO ISSUES. THE DOCTOR REPORTED THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: Occlusion

  MAUDE report 8302706 ↗

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