GORE VIABAHN VBX Balloon Expandable Endo BXA062902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132637478), received between Oct 20, 2018 and Jul 2, 2025 — classified as 6 injuries, 2 malfunctions.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITERATURE REVIEWED: COMPARISON OF BRIDGING STENT GRAFT TYPE IN FENESTRATED ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS. MAZROUA, M., ET AL. JOURNAL OF VASCULAR SURGERY VOLUME 81(4): E5. AVAILABLE ONLINE 17 MARCH 2025. THE ABSTRACT HIGHLIGHTED A RETROSPECTIVE REVIEW COMPARING TWO TYPES OF BALLOON-EXPANDABLE STENTS USED IN FENESTRATED ENDOVASCULAR ANEURYSM REPAIR (FEVAR) PROCEDURES USING COMMERCIALLY AVAILABLE COOK ZENITH FENESTRATED GRAFTS AT A MULTIHOSPITAL HEALTH CARE INSTITUTION FROM 2014 TO 2022. REVIEW INCLUDED 139 PATIENTS (266 TARGET VESSELS), WITH 256/266 DEVICES IMPLANTED IN THE RENAL ARTERIES. ATRIUM ICAST WAS USED EXCLUSIVELY UNTIL 2017. AFTER 2017, A TOTAL OF 159 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED IN THE VISCERAL ARTERIES, AND ATRIUM ICAST USAGE DECREASED SIGNIFICANTLY. TECHNICAL SUCCESS WAS 96.2% (VBX 98.1%; ICAST 93.5%) DUE TO REQUIRED UNPLANNED EXTENSION RATES. AT ONE YEAR, FREEDOM FROM COMPLICATIONS WAS 117 FOR VBX DEVICES, AND 93 FOR ICAST. FIVE-YEAR RESULTS, ATRIUM ICAST DEMONSTRATED BETTER LONG TERM FREEDOM FROM STENT-SPECIFIC COMPLICATIONS. PATIENT DETAILS OBTAINED FROM AUTHOR: ON (B)(6) 2021, ONE PATIENT WAS I

  Patient problems: Obstruction/Occlusion

  MAUDE report 22389136 ↗
• InjuryMay 20, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  LITERATURE REVIEWED: COMPARISON OF BRIDGING STENT GRAFT TYPE IN FENESTRATED ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS. MAZROUA, M., ET AL. JOURNAL OF VASCULAR SURGERY VOLUME 81(4): E5. AVAILABLE ONLINE 17 MARCH 2025. THE ABSTRACT HIGHLIGHTED A STUDY COMPARING TWO TYPES OF BALLOON-EXPANDABLE STENTS USED IN FENESTRATED ENDOVASCULAR ANEURYSM REPAIR (FEVAR) PROCEDURES THAT WERE PERFORMED BETWEEN 2014 AND 2022 IN 139 PATIENTS (266 TARGET VESSELS; 256 IN THE RENAL ARTERIES). ATRIUM ICAST OR WERE IMPLANTED. ATRIUM ICAST WAS USED EXCLUSIVELY UNTIL 2017. A TOTAL OF 159 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED AFTER 2017. PRIMARY OUTCOMES FOR COMPOSITE TECHNICAL SUCCESS AND FREEDOM FROM UNPLANNED EXTENSION WAS SIGNIFICANTLY HIGHER IN THE VBX GROUP (150 VS 90), DRIVEN MAINLY BY HIGHER UNPLANNED EXTENSION RATES FOR ATRIUM ICAST. THERE WERE NINE UNPLANNED EXTENSIONS FOR THE VBX DEVICES. SECONDARY OUTCOMES INCLUDED POSTOPERATIVE ACUTE KIDNEY INJURY (12% FOR VBX; 11% FOR ICAST). AT ONE YEAR, FREEDOM FROM COMPLICATIONS WAS 117 FOR VBX DEVICES, AND ONE YEAR FREEDOM FROM OCCLUSION WAS 119 FOR VBX DEVICES. ATRIUM ICAST DEMONSTRATED BETTER LONG TERM FREE

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 22057181 ↗
• InjuryJul 26, 2022Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022 A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A COOK EVAR DEVICE IN COMBINATION WITH THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WITHIN THE LEFT AND RIGHT RENAL ARTERIES AS WELL AS THE SUPERIOR MESENTERIC ARTERY. DURING THE INDEX PROCEDURE, THROMBOSIS WAS IDENTIFIED WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. ADDITIONALLY, IT WAS STATED THAT PHYSICIAN IDENTIFIED THROMBOSIS IN SEVERAL VESSELS THROUGHOUT THE BODY (VESSELS UNKNOWN). THE PATIENT TOLERATED THE PROCEDURE. ON THE SAME DAY, POST PROCEDURE, THE PHYSICIAN STATED THAT BOWEL NECROSIS WAS OBSERVED DUE TOO THROMBOSIS. THE PHYSICIAN STATED THE PATIENT WILL BE MONITORED. (B)(6) 2022 THE PATIENT EXPIRED. IT WAS STATED BY THE PHYSICIAN THAT THERE WAS OCCLUSION OBSERVED WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES. THE PHYSICIAN STATED THERE IS NO ALLEGATION OF DEVICE DEFICIENCY NOR IS THERE A DIRECT LINK BETWEEN THE DEATH OF PATIENT AND THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. (B)(4).

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 15103487 ↗
• MalfunctionJul 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE ILIAC ARTERY DURING TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. DURING THE POSITIONING OF THE VBX DEVICE INSIDE THE PATIENT, THE VBX DEVICE HAD BECOME DISLODGED FROM THE DELIVERY CATHETER. THE VBX DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Aneurysm; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080571 ↗
• InjuryJun 9, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO GORE THAT POST AAA PROCEDURE USING A COOK EVAR DEVICE WITH THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IMPLANTED IN THE LEFT AND RIGHT RENAL ARTERIES AS WELL AS THE SUPERIOR MESENTERIC ARTERY, PATIENT EXPERIENCED THROMBOSIS. REPORTEDLY THE INDEX PROCEDURE WENT WELL BUT POST PROCEDURE THE PATIENTS BOWELS BECAME NECROTIC FROM THROMBOSIS. IT WAS REPORTED THAT THE PATIENT WILL BE MONITORED AND FURTHER UPDATE WILL BE SENT WITH PATIENT OUTCOME. FSA PROVIDED FURTHER UPDATE TO EVENT: IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT PASSED AWAY. REPORTEDLY THERE WAS OCCLUSION OBSERVED WITHIN THE VBX DEVICES, HOWEVER THE PATIENT HAD THROMBOSIS OBSERVED IN MANY VESSELS THOUGH OUT THE BODY (WITH AND WITHOUT THE VBX STENT PRESENT). IT WAS REPORTED THAT THE PHYSICIAN STATES THERE IS NO ALLEGATION OF DEVICE DEFICIENCY NOR IS THERE A DIRECT LINK BETWEEN THE DEATH PATIENT AND THE GORE DEVICE. 2203-A: OTHER- THROMBOSIS.

  Patient problems: Stenosis

  MAUDE report 14645422 ↗
• InjuryJun 7, 2022Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING AE WAS RECEIVED FOR (B)(6). SUBJECT: (B)(6) SITE: (B)(6) MEDICAL CENTER AT (B)(6) FORM: FORM: FORM 22 - ADVERSE EVENT. VISIT: ADVERSE EVENT - 04 DESCRIPTION: RIGHT RENAL STENT OCCLUSION ONSET DATE: (B)(6) 2022 THIS MAY BE RELATED TO (B)(4).

  Patient problems: Obstruction/Occlusion

  MAUDE report 14625897 ↗
• InjuryJan 9, 2020Complete Blockage; Complete Blockage

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED FOR AORTIC ANEURYSM REPAIR. THE DOCTOR SELECTED A COOK FENESTRATED DEVICE FOR THE AAA REPAIR AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS FOR THE LEFT RENAL FENESTRATION. THE COOK DEVICE WAS PLACED WITH NO ISSUE. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS PLACED WITH NO ISSUE, AND BALLOONED USING AN 8MM BALLOON, CAUSING THE DEVICE TO FORESHORTEN. THE DOCTOR OBSERVED THAT THE DEVICE WAS IN AN ACCEPTABLE POSITION AND COMPLETED THE CASE. THE PATIENT PRESENTED THE FOLLOWING DAY WITH AN OCCLUDED GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE DOCTOR USED TPN TO BREAK THE CLOT UP, A PENUMBRA DEVICE TO SUCTION OUT THE CLOT, AND ANOTHER GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS TO RELINE THE PREVIOUS VBX DEVICE.

  Patient problems: Aneurysm

  MAUDE report 9572218 ↗
• MalfunctionOct 20, 2018Premature Separation; Premature Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT WAS UNDERGOING TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A COOK FENESTRATED AAA DEVICE SYSTEM. FOLLOWING IMPLANTATION OF THE MAIN BODY OF THE COOK DEVICE, THE RENAL ARTERIES WERE CANNULATED. A 6MM X 40MM EV3 EVERFLEX STENT WAS PLACED IN THE LEFT RENAL ARTERY. AN ATTEMPT WAS MADE TO ADVANCE A 7FR SHEATH INTO THE RIGHT RENAL ARTERY FOR DELIVERY OF A 6MM X 29MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE SHEATH WAS ADVANCED TO THE OPENING OF THE RIGHT RENAL ARTERY, SINCE IT WOULD NOT GO INSIDE THE ARTERY. THE VBX DEVICE WAS PUSHED AND PULLED IN ATTEMPT TO CANNULATE THE ARTERY. THE STENT THEN DISLODGED FROM THE BALLOON DELIVERY CATHETER. THIS WAS REPORTEDLY LIKELY DUE TO PUSHING TOO HARD AS WELL AS THE DEVICE POSSIBLY CATCHING ON THE PREVIOUSLY IMPLANTED DEVICE AND/OR CATCHING ON SOME CALCIUM AT THE ORIGIN OF THE RENAL ARTERY. AS WELL, THE SHEATH COULDN¿T BE ADVANCED AS FAR AS DESIRED TO PROTECT THE DEVICE. THE VBX WAS NOT ABLE TO BE RECAPTURED, SO IT WAS LEFT IN THE PATIENT, WITHIN THE ANEURYSM WHERE IT WAS SUCCESSFULLY COVERED BY THE COOK MAIN BODY DEVICES. EVENTUALLY A 12FR GORE® DRYSEAL SHEA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7988149 ↗

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