GORE VIABAHN VBX Balloon Expandable Endo BXA057902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00733132637454), received between Jul 28, 2020 and Jun 20, 2025 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2025Complete Blockage; Complete Blockage

  ON (B)(6) 2024, PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 5 DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES. THE VBX DEVICES WERE IMPLANTED IN SUPERIOR MESENTERIC ARTERY, CELIAC ARTERY, LEFT AND RIGHT RENAL ARTERIES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PHYSICIAN REPORTED THE PATIENT'S LEFT RENAL ARTERY WAS OCCLUDED AT THE JUNCTION WHERE THE TAMBE (PORTALS OF AORTIC COMPONENT) AND VBX DEVICE MEET AND ENTER THE LEFT RENAL ARTERY (LRA). THE LRA IS REPORTED TO BE FULLY THROMBOSED. THE PATIENT IS ON ANTICOAGULANTS; NO RE-INTERVENTION IS PLANNED AT THIS TIME. IT IS UNKNOWN IF BOTH VBX DEVICES OCCLUDED OR JUST THE ONE AT THE PORTAL JUNCTION. REPORTEDLY, THROMBUS WAS NOT AN ISSUE AT THE TIME OF THE IMPLANT. CURRENTLY, THERE IS NO ADDITIONAL INFORMATION ON WHAT THE PHYSICIAN BELIEVES MAY HAVE LED TO THE COMPLETE THROMBOSIS OF THE LEFT RENALS. THERE IS NO FURTHER INFORMATION AT THIS TIME REGARDING PATIENT STATUS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22298827 ↗
• InjuryFeb 18, 2025Device Endoleak; Device Endoleak

  A STUDY ALERT FROM THE PIVOTAL AAA 17-01 (TAMBE) CLINICAL STUDY WAS RECEIVED: ON (B)(6) 2021, A MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) IN THE AAA1701 TAMBE PIVOTAL STUDY. SEVERAL GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE(S)) WERE IMPLANTED AS SIDE BRANCH DEVICES. THE VBX DEVICES WERE IMPLANTED IN SUPERIOR MESENTERIC ARTERY (SMA), CELIAC ARTERY, LEFT AND RIGHT RENAL ARTERIES. ON (B)(6) 2024 , A TYPE 1C ENDOLEAK WAS OBSERVED IN THE RIGHT RENAL ARTERY (BXA057902A). THE CAUSE OF THE ENDOLEAK WAS LACK OF ARTERIAL WALL APPOSITION. ON (B)(6) 2025, AN ENDOVASCULAR REINTERVENTION WAS PERFORMED. DURING THE PROCEDURE, THE RIGHT RENAL ARTERY WITH THE ENDOLEAK WAS EXTENDED WITH A REDUCED PROFILE VBX DEVICE. THE ENDOLEAK WAS RESOLVED.

  Patient problems: Clinical Endoleak

  MAUDE report 21404089 ↗
• InjuryJun 5, 2024Complete Blockage; Complete Blockage

  THE FOLLOWING WAS REPORTED FROM A STUDY: ON (B)(6) 2020, THE STUDY PATIENT WAS TREATED FOR AORTIC ANEURYSM. AS A STAGED PROCEDURE, A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED. A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE) WAS IMPLANTED. AS BRANCH DEVICE COMPONENTS, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES) WERE IMPLANTED IN THE RENAL ARTERIES. TWO VBX DEVICES WERE OVERLAPPED AND DEPLOYED AS ONE UNIT IN THE RIGHT RENAL ARTERY, AND ONE VBX DEVICE IN THE LEFT RENAL ARTERY. ON AUGUST 24, 2022, THE PATIENT PRESENTED TO HOSPITAL WITH ACUTE KIDNEY INJURY FROM THE LEFT RENAL ARTERY OCCLUSION. THIS ADVERSE EVENT LED TO ACUTE RENAL FAILURE. ON THE SAME DATE, RIGHT RENAL ARTERY OCCLUSION WAS ALSO REPORTED. ON AUGUST 26, 2022, THE PATIENT BEGAN IN-PATIENT HEMODIALYSIS AND IT WAS STOPPED ON SEPTEMBER 1, 2022. EXACT START DATE OF OUTPATIENT DIALYSIS IS UNKNOWN; HOWEVER, PATIENT STATED ONGOING OUTPATIENT DIALYSIS IS DONE EACH WEEK (MONDAYS, WEDNESDAYS, AND FRIDAYS).

  Patient problems: Renal Impairment; Thrombosis/Thrombus

  MAUDE report 19472266 ↗
• InjuryDec 21, 2022Complete Blockage; Complete Blockage

  ON (B)(6) 2021, A STUDY PATIENT UNDERWENT TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX DEVICES) WERE USED AS BRANCH DEVICES. TWO VBX DEVICES WERE IMPLANTED, ONE IN EACH RENAL ARTERY. ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH RENAL FAILURE, RELATED TO A LEFT RENAL ARTERY STENT AND RIGHT ARTERY OCCLUSION. LEFT RENAL ARTERY OCCLUSION WAS REPORTED AS SPONTANEOUS; CAUSE UNKNOWN AND IS DEVICE-RELATED. ON OR AROUND (B)(6) 2022 PATIENT WAS TREATED WITH MEDICATIONS, LAB WORK AND SCANS WERE COMPLETED. NEPHROLOGY WAS CONSULTED FOR DIALYSIS. PATIENT RECEIVED HEMODIALYSIS STARTING (B)(6) 2022 AND CONTINUES TO RECEIVE TREATMENT THREE TIMES PER WEEK. ON (B)(6) 2022, THE RIGHT RENAL ARTERY WAS TREATED BY SUCTION THROMBECTOMY / TPA. COMPLETION ANGIOGRAM DEMONSTRATED WIDELY PATENT RIGHT RENAL ARTERY STENT WITH FLOW INTO THE RIGHT KIDNEY. RENAL ULTRASOUND DONE ON (B)(6) 2022, SHOWED RIGHT RENAL ARTERY: 0-59% STENOSIS WITH NO EVIDENCE OF HEMODYNAMICALLY SIGNIFICANT STENOSIS. ALSO NOTED: KNOWN ATROPHIC KIDNEY / LEFT RENAL ARTERY: UNABLE TO VISUALIZE; KNOWN OCCLUDED RENAL ARTERY. THE DEVICES REMAIN IMPLANTED. THE PATIENT TOLERATED THE PR

  Patient problems: Renal Failure; Thrombosis/Thrombus

  MAUDE report 16025684 ↗
• InjuryJul 26, 2022Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2020, THE PATIENT UNDERWENT TREATMENT FOR AN THORACOABDOMINAL AORTIC ANEURYSM WITH THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IMPLANTED IN THE RIGHT RENAL ARTERY. ON THE SAME DAY IT WAS NOTED BY THE PHYSICIAN THAT THERE WAS CONCERN WITH THE PATENCY OF THE RIGHT RENAL STENT AND THOUGHT THAT IT MIGHT BE COMPRESSED AT THE LEVEL JUST PROXIMAL TO THE MAIN BODY PORT. ON (B)(6) 2020 IT WAS OBSERVED THAT THROMBOSIS OCCURRED IN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IMPLANTED IN THE RIGHT RENAL ARTERY. THE PHYSICIAN NOTED THAT NO INTERVENTION WAS REQUIRED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15106596 ↗
• InjuryJul 18, 2022Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE FROM MEDRIO FOR THE AAA 17-01 CLINICAL STUDY: ON (B)(6) 2021, A PATIENT RECEIVED A PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM WITH THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS BEING IMPLANTED IN THE RIGHT RENAL ARTERY. PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, OCCLUSION WAS OBSERVED IN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS LOCATED IN THE RIGHT RENAL ARTERY. PER THE PHYSICIAN, NO INTERVENTION IS REQUIRED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15042314 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE): ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH A GORE® CONTRALATERAL LEG ENDOPROSTHESES, AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WITH THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). THE PATIENT WAS BEING TREATED FOR AN AORTIC ANEURYSM INVOLVING THE VISCERAL VESSEL(S). IT WAS REPORTED THAT ON (B)(6) 2020, IMAGES REVEALED A TYPE IC ENDOLEAK. THE TYPE IC ENDOLEAK WAS IDENTIFIED ON THE 1 MONTH DUPLEX US AND CTA SCAN. THE PATIENT WAS SCHEDULED FOR A REINTERVENTION SURGERY WITH DR. JORDAN TO TREAT THE TYPE IC ENDOLEAK.

  Patient problems: Aneurysm

  MAUDE report 14795393 ↗
• InjuryJun 23, 2022Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING INFORMATION WAS RECEIVED FROM MEDRIO: SUBJECT: (B)(4), SITE: (B)(6), FORM: FORM 22 - ADVERSE EVENT, VISIT: ADVERSE EVENT - 03, AE: RIGHT RENAL STENT GRAFT OCCLUSION, ONSET DATE: UNK.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14794041 ↗
• InjuryMay 17, 2021Partial Blockage; Partial Blockage

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020 A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN AORTIC ANEURYSM IN PART WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX). THE VBX DEVICES WERE UTILIZED IN BOTH RENAL ARTERIES. ON (B)(6) 2021, THE LEFT RENAL ARTERY WAS FOUND TO BE STENOSED. NO INTERVENTION WAS REPORTED.

  Patient problems: Stenosis

  MAUDE report 11837818 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021 A PATIENT UNDERWENT TREATMENT OF A THORACOABDOMINAL ANEURYSM IN THE AAA1701 TAMBE CLINICAL TRIAL. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE UTILIZED IN AORTIC BRANCH VESSELS. ON (B)(6) 2021 THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IN THE RIGHT RENAL ARTERY BECAME THROMBOSED. THIS LED TO ACUTE KIDNEY INJURY. ON (B)(6) 2021 A DIAGNOSTIC ANGIOGRAM WAS PERFORMED WITH ATTEMPTED PERCUTANEOUS THROMBECTOMY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11599263 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020 A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN AORTIC ANEURYSM WITH INVESTIGATIONAL TAMBE DEVICES. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE UTILIZED IN BOTH RENAL ARTERIES. ON (B)(6) 2020 THE RIGHT RENAL ARTERY WAS FOUND TO BE THROMBOSED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11477578 ↗
• InjuryFeb 12, 2021Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021 A PATIENT UNDERWENT TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM IN THE AAA17-01 (B)(6) STUDY. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE USED IN THE RENAL ARTERIES. ON (B)(6) 2021 THE LEFT RENAL ARTERY WAS FOUND TO BE OCCLUDED. THE PATIENT WAS TREATED WITH MEDICATION FOR FLANK PAIN, WHICH PROLONGED HOSPITALIZATION.

  Patient problems: Pain

  MAUDE report 11325351 ↗
• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020 A PATIENT UNDERWENT ENDOVASCULAR AORTIC DEBRANCHING WITH INVESTIGATIONAL TAMBE DEVICES. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE UTILIZED IN BOTH RENAL ARTERIES. ON (B)(6) 2020 THE PATIENT EXHIBITED ACUTE KIDNEY INJURY, WHICH WAS REPORTED TO HAVE BEEN POSSIBLY DEVICE RELATED. THE KIDNEY INJURY WAS NOT SPECIFIED TO A CERTAIN SIDE, BUT RATHER DETECTED AS A GENERAL FINDING IN A KIDNEY FUNCTION TEST. NO TREATMENT WAS RENDERED AND THE CASE IS ONGOING.

  Patient problems: No Known Impact Or Consequence To Patient; Renal Failure

  MAUDE report 10608257 ↗
• MalfunctionJul 28, 2020Mechanical Problem; Patient-Device Incompatibility; Mechanical Problem; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT WAS BEING TREATED FOR A THORACIC AORTA ANEURYSM USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) PLACED IN A RENAL ARTERY AS A BRANCH DEVICE. THE DEVICE WAS ADVANCED TO THE OSTIUM OF THE RENAL ARTERY FOR PLACEMENT AND MET RESISTANCE DUE TO THE PATIENT¿S TORTUOUS ANATOMY. THE PHYSICIAN DECIDED TO REMOVE THE DEVICE FROM THE PATIENT. AS THE DEVICE WAS BEING REMOVED FROM THE PATIENT¿S BODY THE DEVICE WAS ATTEMPTED TO BE WITHDRAWN THROUGH THE SHEATH. THE STENT GRAFT DISLODGED FROM THE CATHETER. THE PHYSICIAN STATED THE SUSPECTED CAUSE OF THE CATHETER DISLODGING WAS THE EDGE OF THE STENT GOT CAUGHT ON THE EDGE OF THE SHEATH DURING WITHDRAWAL. THE STENT AND CATHETER WERE ABLE TO BE WITHDRAWN FROM THE PATIENT IN TANDEM WITH THE SHEATH. ANOTHER VBX WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10333831 ↗

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