GORE VIABAHN VBX Balloon Expandable Endo BXA093902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132637355), received between Jul 22, 2020 and Dec 12, 2024 — classified as 1 death, 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Collapse” (1 report).

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.

• MalfunctionDec 12, 2024Material Integrity Problem; Material Integrity Problem

  THE FOLLOWING INFORMATION WAS RECEIVED FROM A CLINICAL STUDY: ON (B)(6) 2022, A AAA PROCEDURE WAS PERFORMED AND A TAMBE DEVICE WAS IMPLANTED IN A STUDY PATIENT. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) WERE IMPLANTED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. DURING PATIENT FOLLOW-UP ON (B)(6) 2024, IMAGING WAS PERFORMED. OBSERVED WAS DEVICE OVALIZATION OF THE SUPERIOR MESENTERIC ARTERY COMPONENT WITHIN THE AORTA AT THE LEVEL OF THE CELIAC ARTERY. THERE WERE NO REPORTED FRACTURES AND THE BRANCH DEVICES REMAIN PATENT. NO INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919647 ↗
• DeathJul 14, 2023Complete Blockage; Complete Blockage

  ON (B)(6) 2023, THE PATIENT ARRIVED ABOUT 10AM WITH ABDOMINAL PAIN, NAUSEA, AND VOMITING AFTER EATING FOOD. CT REVEALED OCCLUSION OF SMA, BILATERAL RENAL STENTS AND ASSOCIATED INFARCTION OF THE SPLEEN AND BILATERAL KIDNEYS. VASCULAR SURGEON WAS UNAVAILABLE AT THE FIRST FACILITY, SO PATIENT WAS REFERRED TO ANOTHER FACILITY. AT SECOND FACILITY THE PATIENT ALREADY HAD AT LEAST 12 HOURS OF WARM ISCHEMIA TIME FOR BOTH KIDNEYS AND WAS NOT MAKING URINE. THE PATIENT WAS GIVEN DILAUDID®. PATIENT CONTINUED TO HAVE PAIN AND WITH CTA FINDINGS, URGENT EXPLORATION WAS SCHEDULED. THE PATIENT WAS INFORMED IF VIABLE BOWEL IS FOUND, A BYPASS WILL BE DONE, THEN A SECOND EXPLORATION AND HEMODIALYSIS WOULD BE NECESSARY. AS REPORTED, PATIENT HAD BEEN EXPERIENCING SEVERE MUSCLE PAIN OVER THE LAST SEVERAL WEEKS, LEADING TO CESSATION OF HIS STATIN AND PREDNISONE THERAPY. HE WAS ALSO TAKEN OFF PLAVIX. CARDIOLOGIST NOTES STATED AORTIC STENOSIS WAS SOMEWHAT SIGNIFICANT, WITH EJECTION FRACTION OF 60%. IN MARCH 2023, PATIENT HAD A CT ANGIOGRAM OF THE TAMBE DEVICE AND ALL FOUR BRANCH DEVICES TO THE SMA, CELIAC AND BILATERAL RENAL ARTERIES WERE PATENT AT THAT TIME. ON (B)(6) 2023, EXPLORATORY LAPAROTOMY AND BYPAS

  Patient problems: Obstruction/Occlusion; Renal Failure

  MAUDE report 17329603 ↗
• InjuryMar 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023, THE PATIENT UNDERWENT A CARDIAC PROCEDURE TO IMPLANT AN IMPELLA® HEART PUMP DEVICE WHERE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS USED TO CLOSE THE SHEATH ACCESS POINT IN THE COMMON FEMORAL ARTERY. IT WAS REPORTED THE PHYSICIAN ACCESSED THE HEART PUMP TREATMENT AREA VIA THE COMMON FEMORAL ARTERY USING A 25F SHEATH (BRAND UNKNOWN). AFTER THE HEART PUMP PROCEDURE, THE PHYSICIAN ATTEMPTED TO CLOSE THE SHEATH ACCESS POINT WITH THE 9 MM X 39 MM VBX DEVICE. REPORTEDLY, THE BALLOON INFLATED AND DEFLATED WITHOUT ISSUE, BUT THE DELIVERY CATHETER WOULD NOT DETACH FROM THE STENT. AN ATTEMPT WAS MADE TO PLACE A WIRE PAST THE AFFECTED AREA WITH ANOTHER BALLOON TO TRY TO DETACH THE DELIVERY SYSTEM FROM THE DEPLOYED STENT, BUT WAS UNSUCCESSFUL. THE DECISION WAS THEN MADE TO DO A CUT DOWN TO REMOVE THE DELIVERY SYSTEM AND STENT GRAFT. IT WAS REPORTED THE PHYSICIAN DID NOT STATE ANY SUSPICION AS TO WHY THE DELIVERY SYSTEM WOULD NOT DETACH. THE PATIENT TOLERATED THE PROCEDURE. POST ANGIOGRAPHY SHOWED BLOOD FLOW.

  Patient problems: Failure of Implant

  MAUDE report 16566927 ↗
• InjuryJan 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A JUXTARENAL ABDOMINAL AORTIC ANEURYSM IN THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) CLINICAL TRIAL. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS USED DURING THE PROCEDURE. ON (B)(6) 2022, A TYPE III ENDOLEAK WAS OBSERVED IN THE PATIENT'S SUPERIOR MESENTERIC ARTERY (SMA). AN ADDITIONAL STENT WAS PLACED IN THE TREATED SMA SEGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16119105 ↗
• InjuryJul 19, 2022Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE FROM MEDRIO FOR CLINICAL STUDY (B)(4): ON (B)(6) 2020, THE PATIENT UNDERWENT TREATMENT FOR A THORACOABDOMINAL AORTIC ANEURYSM WITH THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS BEING IMPLANTED IN THE CELIAC ARTERY. ON (B)(6) 2022, THE PHYSICIAN NOTED THAT OCCLUSION WAS PRESENT WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IMPLANTED WITHIN THE CELIAC ARTERY. THE PHYSICIAN NOTED THAT THE OCCLUSION WAS LIKELY DUE TO MEDIAN ARCUATE LIGAMENT COMPRESSION. THE PHYSICIAN NOTED THAT NO INTERVENTION WAS NEEDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15057852 ↗
• MalfunctionMar 9, 2021Collapse; Collapse

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020 A PATIENT WAS UNDERGOING TREATMENT OF A THORACO-ABDOMINAL ANEURYSM WITHIN THE AAA17-01 TAMBE CLINICAL STUDY. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE UTILZED IN THE BRANCH VESSELS. A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WAS USED IN THE ILIAC ARTERY REGION. ON (B)(6) 2020 IMAGING REVEALED THE FOLLOWING: THE CELIAC ARTERY SIDE BRANCH COMPONENT IS COMPRESSED AS IT PASSES BETWEEN THE SMA SIDE BRANCH COMPONENT AND THE AORTIC COMPONENT. THE CELIAC ARTERY SIDE BRANCH COMPONENT WRAPS 360 DEGREES AROUND THE SMA SIDE BRANCH COMPONENT. SMALL AMOUNT OF THROMBUS PRESENT IN THE LSA. PEDUNCULATED LESION JUST PROXIMAL TO THE TAMBE AORTIC COMPONENT WITHIN THE AORTA. TYPE II ENDOLEAK WITH IMA AND LUMBAR ARTERY INVOLVEMENT. THE IMAGING FINDING WAS CLARIFIED FURTHER AS FOLLOWS: THE CA AND SMA DEVICES ARE WRAPPED AROUND EACH OTHER IN THE AORTA BEFORE EACH REACHES THEIR RESPECTIVE VESSELS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11448856 ↗
• InjuryJul 22, 2020Peeled/Delaminated; Peeled/Delaminated

  THE DEVICE IS NOT AVAILABLE FOR RETURN TO THE U.S. FOR AN EVALUATION.

  Patient problems: No Code Available

  MAUDE report 10309017 ↗

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