GORE VIABAHN VBX Balloon Expandable Endo BXA073902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00733132637270), received between Dec 6, 2018 and Mar 24, 2026 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Complete Blockage; Biocompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT UNDERWENT A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE. DURING THIS PROCEDURE, SEVERAL GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES) WERE IMPLANTED IN THE VISCERAL ARTERIES AS BRANCH DEVICES. ON (B)(6) 2026, THE PATIENT DEVELOPED ABDOMINAL PAIN THAT PROGRESSIVELY WORSENED AND WAS ACCOMPANIED BY COFFEE-GROUND EMESIS. ON (B)(6) 2026, A REPEAT CTA SHOWED INTERVAL OCCLUSION DUE TO VBX STENT THROMBOSIS OF THE CELIAC, RIGHT AND LEFT RENAL ARTERIES. THE VBX STENT IN THE SMA REMAINED PATENT AS THE SOLE MESENTERIC INFLOW. LABORATORY RESULTS ON THIS DATE SHOWED ELEVATED BUN (59 MG/DL) AND CREATININE (3.09 MG/DL). BASED ON THE CTA FINDINGS AND THE SEVERITY OF HIS ABDOMINAL PAIN, THE PATIENT WAS TAKEN EMERGENTLY FOR ENDOVASCULAR THROMBECTOMY OF THE CELIAC AND RENAL VBX DEVICES, INCLUDING THROMBUS CLEARANCE FROM THE ASSOCIATED TAMBE RENAL AND CELIAC PORTALS. ON (B)(6) 2026, ACCORDING TO THE PHYSICIAN, THE PATIENT WAS NOTED TO HAVE LOSS OF KIDNEY FUNCTION FOLLOWING THE PROCEDURE. ADDITIONALLY, THE TREATING PHYSICIAN REPORTED THE PRESENCE OF AN ACTIVE GASTRIC ULCER WITH HEMATEMESIS AND

  Patient problems: Obstruction/Occlusion; Renal Impairment

  MAUDE report 24682394 ↗
• 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 RIGHT RENAL ARTERY COMPONENT WITHIN THE AORTA, JUST PROXIMAL TO THE RIGHT RENAL 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 20919629 ↗
• MalfunctionFeb 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024 THE PATIENT UNDERWENT EMERGENCY TREATMENT FOR BOWEL ISCHEMIA WHERE A 7 MM X 39 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS GOING TO BE USED IN THE SUPERIOR MESENTERIC ARTERY (SMA). IT WAS REPORTED THE PHYSICIAN ACCESSED THE TREATMENT AREA THROUGH DIRECT CANNULATION BECAUSE THE ABDOMEN WAS OPEN, USING A 7F SHEATH (BRAND UNKNOWN) AND AN 0.035" GUIDEWIRE (BRAND UNKNOWN). REPORTEDLY, WHEN THE DELIVERY SYSTEM CATHETER ADVANCED TO THE TARGET TREATMENT SITE, IT WAS DETERMINED THE STENT WAS SLIGHTLY TOO LONG. THE DECISION WAS MADE TO WITHDRAW THE DELIVERY SYSTEM CATHETER FROM THE PATIENT. AN ATTEMPT WAS MADE TO PULL THE STENT BACK INTO THE INTRODUCER SHEATH. RESISTANCE WAS MET, AND FORCE WAS APPLIED. THE BALLOON WAS PULLED INTO THE INTRODUCER SHEATH, BUT THE UNDEPLOYED ENDOPROSTHESIS DISLODGED AND WAS LEFT IN THE ARTERY ON THE GUIDE WIRE. THE CATHETER AND BALLOON WERE WITHDRAWN FROM THE PATIENT. THE PHYSICIAN PULLED THE ENDOPROSTHESIS TO A SAFE LOCATION AND DEPLOYED IT USING ANOTHER BALLOON. THE ENDOPROSTHESIS WAS THEN RELINED WITH A 7 MM X 59 MM VBX DEVICE TO COVER AND PIN IT DOWN SO IT WOULD NOT MIGRATE INTO THE AORTA. IT WAS REPORTED THERE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623101 ↗
• InjuryJun 29, 2023Partial Blockage; Partial Blockage

  ON (B)(6) 2022, A STUDY PATIENT UNDERWENT AN AAA PROCEDURE. DURING THIS PROCEDURE, MULTIPLE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) WERE IMPLANTED IN THE CELIAC, RIGHT AND LEFT RENAL ARTERIES. ON (B)(6) 2023, THE PATIENT PRESENTED WITH VBX STENT STENOSIS. AS REPORTED, THE STENOSIS WAS PRESENT IN BOTH RENAL ARTERIES. INTERVENTION WAS PERFORMED WITH BALLOON ANGIOPLASTY AND NON-GORE STENTS WERE IMPLANTED IN BOTH RENAL ARTERIES TO RELINE THE EXISTING VBX STENTS. AS STATED, THE REINTERVENTION WAS PERFORMED IN THE TREATED SEGMENTS TO PREVENT EVENTUAL LOSS OF PATENCY. THE PATIENT RECOVERED WELL FOLLOWING THE INTERVENTION.

  Patient problems: Stenosis

  MAUDE report 17227707 ↗
• MalfunctionJun 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023, THE PATIENT UNDERWENT TREATMENT IN THE SUPERIOR MESENTERIC ARTERY (SMA) FOR PERIPHERAL ARTERIAL DISEASE USING A 7 MM X 39 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). IT WAS REPORTED THE PHYSICIAN ACCESSED THE TREATMENT AREA USING A 7F DESTINO STEERABLE GUIDING SHEATH AND AN UNKNOWN BRAND 0.035" GUIDEWIRE. REPORTEDLY, THE DELIVERY SYSTEM CATHETER MET SOME RESISTANCE DURING ADVANCEMENT. THE VBX DEVICE WOULD NOT ADVANCE INTO THE SMA. THE DECISION WAS MADE TO WITHDRAW THE DEVICE FROM THE PATIENT. AN ATTEMPT WAS MADE TO PULL THE STENT BACK INTO THE INTRODUCER SHEATH. THE BALLOON WAS PULLED INTO THE INTRODUCER SHEATH, BUT THE UNDEPLOYED STENT DISLODGED AND WAS LEFT IN THE AORTA. THE STENT WAS SUCCESSFULLY REMOVED FROM THE AORTA USING A SNARE CATHETER. THE PHYSICIAN DECIDED TO CONCLUDE THE PROCEDURE WITHOUT FURTHER INTERVENTION. NO IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17056217 ↗
• InjuryJun 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX) IN THE (B)(6) TAMBE PIVOTAL STUDY. ON (B)(6) 2019 A TYPE IC ENDOLEAK WAS OBSERVED IN THE PATIENT'S RIGHT RENAL ARTERY. AN INTERVENTION WAS PERFORMED ON (B)(6) 2019 WHEREBY AN ADDITIONAL VBX DEVICE WAS PLACED DISTALLY TO EXTEND THE MOST DISTAL VBX DEVICE IN THE PATIENT'S RIGHT RENAL ARTERY. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14796262 ↗
• InjuryFeb 19, 2021Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2020 A PATIENT UNDERWENT AORTIC ANEURYSM TREATMENT WITHIN THE (B)(6) CLINICAL STUDY. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE UTILIZED IN THE CELIAC ARTERY. ON (B)(6) 2020 CELIAC ARTERY STENOSIS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11354623 ↗
• InjuryJan 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT WAS BEING TREATED FOR A ILIAC ANEURYSM USING GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX). A VBX DEVICE WAS ADVANCED INTO THE PATIENT COMMON ILIAC ARTERY. THE DEVICE MET RESISTANCE AND THE STENT GRAFT DISLODGED SEPARATING FROM THE CATHETER. THE STENT GRAFT WAS COMPLETELY CONSTRAINED. THE PHYSICIAN STATED THE CAUSE OF THE RESISTANCE AND SEPARATION OF THE DEVICE WAS THE EXTREME TORTUOSITY IN THE PATIENTS ILIAC ARTERY. THE DEVICE WAS LEFT IN THE PATIENTS INTERNAL ILIAC ARTERY AND A COIL EMBOLIZATION WAS PERFORMED. THE PROCEDURE WAS THEN CONCLUDED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 11151360 ↗
• 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 10199681 ↗
• InjuryDec 6, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2018, A PATIENT PRESENTED FOR TREATMENT OF AN ANEURYSMAL CELIAC ARTERY. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE IMPLANTED TO COVER THE AREA FROM THE CELIAC ARTERY ORIGIN TO THE BIFURCATION. FIRST, THE SPLENIC ARTERY WAS COILED, THEN A VBX DEVICE WAS DEPLOYED. THE SECOND VBX DEVICES WAS OVERLAPPED WITH THE FIRST ONE, DEVICES WERE BALLOONED PROPERLY. AS REPORTED, THE CASE WENT WELL AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2018, IT WAS FOUND THE VBX DEVICES HAD OCCLUDED. THE PATIENT WAS TAKEN TO SURGERY FOR OPEN REPAIR. A TEAR WAS ALSO FOUND NEAR THE ORIGIN OF THE CELIAC ARTERY. A BYPASS WAS CREATED AND THE VBX DEVICES WERE EXPLANTED AND DISCARDED. THE PATIENT WAS REPORTED TO BE RECOVERING WELL FOLLOWING THE INTERVENTION.

  Patient problems: Occlusion; Perforation of Vessels

  MAUDE report 8139361 ↗

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