GORE VIABAHN VBX Balloon Expandable Endo BXA097902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00733132637607), received between Jun 26, 2020 and Oct 22, 2025 — classified as 1 death, 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2025, A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE WAS PERFORMED TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM. AS PART OF THE PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX DEVICE) WERE USED IN THE SUPERIOR MESENTERIC ARTERY (SMA). ON (B)(6) 2025, A TYPE III ENDOLEAK WAS IDENTIFIED IN THE SMA BRANCH, ATTRIBUTED TO A DISCONNECTION OF THE VBX DEVICE IMPLANTED IN (B)(6). THE INITIAL VBX STENT GRAFT DID NOT ACHIEVE A COMPLETE SEAL AT ITS DISTAL EDGE, RESULTING IN LEAKAGE INTO THE ANEURYSM SAC. TO ADDRESS THIS, A 9MM X 59MM VBX DEVICE WAS DEPLOYED APPROXIMATELY 3 CM DISTAL TO THE ORIGINAL SITE TO ENSURE PROPER SEAL. DEPLOYMENT AND EXPANSION WERE REPORTEDLY SMOOTH, WITH NO RESISTANCE OR COMPLICATIONS. THE BALLOON WAS POSITIONED SLIGHTLY HIGHER TO ACHIEVE A FINAL DIAMETER OF 9.3MM SUCCESSFULLY RESOLVED THE ENDOLEAK. ADDITIONALLY, A 5MM X 29MM VBX DEVICE WAS PLACED IN THE LEFT RENAL ARTERY AND EXTENDED TO COVER A BRANCH SUSPECTED TO BE THE SOURCE OF A RETROPERITONEAL BLEED. THE RETROPERITONEAL BLEED WAS IDENTIFIED PRIOR TO THE ENDOVASCULAR TREATMENT OF THE ENDOLEAK. REPORTEDLY, THE RETROPERITONEAL BLEED WAS NOT ATTRIBUTED TO THE

  Patient problems: Clinical Endoleak

  MAUDE report 23359292 ↗
• MalfunctionNov 18, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING WAS RECEIVED FROM A CLINICAL STUDY: ON (B)(6) 2020, A STUDY PATIENT UNDERWENT A AAA PROCEDURE AND A TAMBE DEVICE WAS IMPLANTED. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE USED AS BRANCHED DEVICES IN THE VISCERAL ARTERIES. IMAGING PERFORMED ON (B)(6) 2022, AT 24-MONTHS FOLLOW-UP SHOWED THE DISTAL END OF THE THIRD RENAL ARTERY DEVICE (EVERFLEX BMS) REMAINS OCCLUDED, WITH BLOOD FLOW TO OTHER RIGHT RENAL ARTERY BRANCHES. THERE ALSO APPEARED TO BE A SMALL AMOUNT OF COLLATERAL FLOW DISTAL OF THE OCCLUSION. IMAGING ALSO SHOWED OVALIZATION OF THE SUPERIOR MESENTERIC ARTERY (SMA) DEVICE, JUST PROXIMAL TO THE CELIAC ARTERY. NO FRACTURES WERE OBSERVED AND ALL THE BRANCH DEVICES REMAIN PATENT. PATIENT APPEARS TO BE ASYMPTOMATIC AND NO INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20712993 ↗
• MalfunctionOct 24, 2024Dent in Material; Appropriate Device Problem Term/Code Not Available; Dent in Material; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING INFORMATION WAS PROVIDED BY A CLINICAL STUDY SITE: ON (B)(6), 2020, A STUDY PATIENT UNDERWENT AAA PROCEDURE. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. ONE VBX DEVICE WAS IMPLANTED (MOST PROXIMAL WITHIN THE PORTAL) IN THE SUPERIOR MESENTERIC ARTERY (SMA). DURING A FOLLOW-UP VISIT ON (B)(6) 2024, CTA IMAGING WAS COMPLETED. OBSERVED WAS A DEVICE OVALIZATION OF THE SMA SIDE BRANCH COMPONENT WITHIN THE AORTA, JUST PROXIMAL THE SMA ORIGIN. NO FRACTURES WERE NOTED AND ALL THE VBX DEVICES WERE FOUND TO BE PATENT DURING THE VISIT. THE PATIENT IS ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20527900 ↗
• InjuryJul 22, 2024Obstruction of Flow; Migration; Obstruction of Flow; Migration

  INFORMATION RECEIVED FROM A CLINICAL STUDY: ON (B)(6) 2022, THE STUDY PATIENT WAS IMPLANTED WITH SEVERAL GORE® EXCLUDER® DEVICES AND A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE(S)) WERE ALSO IMPLANTED AS BRANCH DEVICES IN THE VISCERAL VESSELS. TWO VBX DEVICES WERE IMPLANTED THE SUPERIOR MESENTERIC ARTERY (SMA), TWO VBX DEVICES IN THE CELIAC ARTERY, AND ONE VBX DEVICE IN THE LEFT RENAL ARTERY. ON (B)(6) 2024, GRAFT LEAKAGE WAS REPORTED FOR AN AORTIC DEVICE. AT THIS TIME, IT WAS FOUND THE VBX DEVICES LOST SEAL IN THREE VESSELS (CELIAC, SMA, AND LEFT RENAL ARTERY). AN ENDOLEAK EXTENDING FROM INFERIOR MESENTERIC ARTERY (IMA) WAS ALSO OBSERVED. IT WAS REPORTED BRANCH DEVICE PATENCY HAD BEEN LOST. ON THE SAME DAY INTERVENTION WAS PERFORMED WITH BALLOON ANGIOPLASTY AND ADDITIONAL STENTS WERE IMPLANTED IN THE THREE VESSELS. AT THE END OF PROCEDURE, THE IMA STILL HAD REMAINING ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19801435 ↗
• InjuryJun 14, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2021, A STUDY PATIENT UNDERWENT TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS IMPLANTED AS BRANCH DEVICES. AS REPORTED, THE PATIENT¿S PRIMARY ADMISSION ON(B)(6) 2023, WAS FOR A THORACIC AORTIC ANEURYSM (WITHOUT RUPTURE). ON (B)(6) 2023, A STUDY DEVICE RELATED TYPE 1C ENDOLEAK WAS OBSERVED IN THE SUPERIOR MESENTERIC ARTERY. ON (B)(6) 2023, INTERVENTION WAS PERFORMED: SELECTIVE CATHETERIZATION, ANGIOGRAM, ANGIOPLASTY, AND STENTING OF THE SUPERIOR MESENTERIC ARTERY. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 17131494 ↗
• DeathNov 18, 2022Complete Blockage; Complete Blockage

  ON (B)(6) 2021, A STUDY PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM IN THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) CLINICAL TRIAL. DURING THIS TREATMENT, SEVERAL GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX DEVICE) WERE IMPLANTED AS BRANCH DEVICES. TWO VBX DEVICES WERE OVERLAPPED AND IMPLANTED AS ONE UNIT IN THE PATIENT'S SUPERIOR MESENTERIC ARTERY. ON THE NIGHT OF (B)(6) 2021, THE PATIENT WAS ADMITTED INTO THE HOSPITAL AND DIAGNOSED WITH ISCHEMIC BOWEL DISEASE AND MESENTERIC ISCHEMIA. A LAPAROSCOPY WAS PERFORMED AROUND 2AM ON (B)(6) 2021. THE PATIENT EXPIRED ON (B)(6) 2021. AS REPORTED, THE PHYSICIAN'S OPINION ABOUT THE CAUSE OF DEATH THIS WAS VERY LIKELY PROCEDURE RELATED, AND IT IS POSSIBLE, BUT SUSPECTED UNLIKELY DEVICE RELATED.¿ THE SMA BRANCH WAS OCCLUDED AND THIS WAS ULTIMATELY WHAT LED TO PATIENT'S DEATH. THE CAUSE OF OCCLUSION IS UNCLEAR.

  Patient problems: Ischemia; Thrombosis/Thrombus

  MAUDE report 15829181 ↗
• InjurySep 27, 2022Collapse; Obstruction of Flow; Collapse; Obstruction of Flow

  ON (B)(6) 2019, A PATIENT RECEIVED TREATMENT FOR A THORACOABDOMINAL AORTIC ANEURYSM USING THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IMPLANTED WITHIN THE SUPERIOR MESENTERIC ARTERY. ON (B)(6) 2022, COMPRESSION OF THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS AND OCCLUSION OF THE SUPERIOR MESENTERIC ARTERY WAS OBSERVED BY THE PHYSICIAN. NO TREATMENT HAS BEEN PERFORMED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15490967 ↗
• InjuryJun 23, 2022Obstruction of Flow; Deformation Due to Compressive Stress; Obstruction of Flow; Deformation Due to Compressive Stress

  SUBJECT: 1701-181-004, ONSET DATE: (B)(6) 2021. DESCRIPTION: COMPRESSION OF THE SUPERIOR MESENTERIC ARTERY DURING PROCEDURE. OUTCOME: RECOVERED/RESOLVED - TREATMENT REQUIRED: ANGIO DEMONSTRATED SOME COMPRESSION OF THE SUPERIOR MESENTERIC ARTERY. RECATHERIZED THE SUPERIOR MESENTRIC ARTERY AND BALLOONED THE STENT GRAFT AT THE COMPRESSED SEGMENT. FLUSH AORTAGRAM DEMONSTRATED AN EXCELLENT RESULT THROUGHOUT WITH BRISK FLOW.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14788840 ↗
• InjurySep 29, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON (B)(6) 2020 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN AORTIC ANEURYSM USING INVESTIGATIONAL TAMBE DEVICES. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX) WERE UTILIZED IN THE PATIENT'S SUPERIOR MESENTERIC ARTERY (SMA). ON (B)(6) 2020 BRANCH STENOSIS OF THE SMA WAS OBSERVED AT THE TRANSITION BETWEEN THE AORTIC SEGMENT AND THE BRANCH VESSEL SEGMENT IN THE BRIDGING VBX DEVICE. IT WAS REPORTEDLY SUSPECTED THAT THE CAUSE OF THE STENOSIS WAS THE INVESTIGATIONAL TAMBE DEVICE ¿SETTLING¿ INTO ITS FINAL SEAL POSITION WHICH MAY HAVE RESULTED IN SLIGHT KINKING OF THE SMA BRANCH STENT. BLOOD FLOW WAS REPORTEDLY PRESENT. ON THE SAME DAY BALLOON ANGIOPLASTY, STENTING, AND SELECTIVE ANGIOGRAPHY OF THE SMA VIA LEFT BRACHIAL CUTDOWN AND SECOND ORDER CANNULATION OF THE SMA WAS PERFORMED. THE ADVERSE EVENT WAS DEEMED RESOLVED ON (B)(6) 2020. THERE WERE NO FURTHER REPORTED ISSUES.

  Patient problems: Stenosis

  MAUDE report 12549257 ↗
• InjuryFeb 24, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020 A PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING AN INVESTIGATIONAL TAMBE DEVICE. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS UTILIZED IN THE SUPERIOR MESENTERIC ARTERY (SMA). ON (B)(6) 2021 A TYPE IC ENDOLEAK INVOLVING THE DEVICE IN THE SMA WAS REPORTED. ON (B)(6) 2021 THE ENDOLEAK WAS TREATED BY MEANS OF BALLOON ANGIOPLASTY AND PLACEMENT OF A PERIPHERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375784 ↗
• InjuryJun 26, 2020Collapse; Collapse

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH A THORACOABDOMINAL AORTIC ANEURYSM (TAAA) CLASS IV THAT WAS SUCCESSFULLY TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND GORE VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES THAT WERE USED AS SIDE BRANCH COMPONENTS. ON (B)(6) 2020, CELIAC BRANCH AND SUPERIOR MESENTERIC ARTERY (SMA) BRANCH STENOSIS WAS IDENTIFIED. ON (B)(6) 2020, ADDITIONAL STENTS WERE IMPLANTED IN THE SMA AND CELIAC ARTERY. ADDITIONALLY BALLOON ANGIOPLASTY WAS DONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND BOTH ARTERIES PATENT.

  Patient problems: Occlusion

  MAUDE report 10199673 ↗

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