GORE VIABAHN VBX Balloon Expandable Endo BXA065902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132637218), received between Nov 24, 2020 and Jul 17, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Complete Blockage” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2023Partial Blockage; Partial Blockage

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6)2023, TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS(S) (VBX DEVICE) WERE INTENDED FOR USE IN THE ILIAC ARTERIES DURING TREATMENT OF BILATERAL ILIAC DISEASE. ON AN UNKNOWN DATE (APPROXIMATELY 15 YEARS AGO) THE PATIENT UNDERWENT TREATMENT FOR BILATERAL ILIAC DISEASE WITH KISSING STENTS (MANUFACTURER UNKNOWN). AFTER BOTH VBX DEVICES WERE SUCCESSFULLY IMPLANTED TO RELINE PREVIOUSLY IMPLANTED DEVICES, BOTH VBX DEVICES OCCLUDED. A REINTERVENTION HAS BEEN PLANNED TO TREAT THE IN-STENT RESTENOSIS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17339397 ↗
• MalfunctionMay 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023, THE PATIENT UNDERWENT TREATMENT IN THE COMMON ILIAC ARTERY FOR AN UNKNOWN ETIOLOGY USING A 6 MM X 59 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). IT WAS REPORTED THE PHYSICIAN ADVANCED THE DELIVERY SYSTEM CATHETER THROUGH A 7F BRITE TIP SHEATH INTRODUCER AND OVER A .035" TERUMO GLIDEWIRE ADVANTAGE GUIDEWIRE (260 CM). REPORTEDLY, THE LESION WAS PRE-DILATED BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). HOWEVER, DURING ADVANCEMENT RESISTANCE WAS MET IN THE EXTERNAL ILIAC ARTERY DUE TO SEVERE CALCIFICATION, AND THE DELIVERY SYSTEM WAS UNABLE TO ADVANCE ACROSS THE LESION. THE DELIVERY SYSTEM WAS WITHDRAWN BACK THROUGH THE INTRODUCER SHEATH. UPON REMOVAL, IT WAS OBSERVED THE STENT-GRAFT HAS MOVED SLIGHTLY FORWARD ON THE BALLOON, BUT THE STENT-GRAFT DID NOT DETACH FROM THE DELIVERY SYSTEM INSIDE THE PATIENT. THE PHYSICIAN SUSPECTS THE STENT-GRAFT MOVEMENT WAS DUE THE WITHDRAWAL BACK THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED USING A DIFFERENT VBX DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16935490 ↗
• InjuryNov 1, 2022Complete Blockage; Complete Blockage

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, A STUDY PATIENT UNDERWENT TREATMENT OF A THORACOABDOMINAL AND PARARENAL AORTIC ANEURYSM. DURING THIS TREATMENT, SEVERAL GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX DEVICE) WERE IMPLANTED AS SIDE BRANCHES. TWO VBX DEVICES (6MM X 59MM; 6MM 79MM) WERE OVERLAPPED AND IMPLANTED IN THE RIGHT RENAL ARTERY. TWO VBX DEVICES (7MM X 79MM; 7MM X 39MM) WERE OVERLAPPED AND IMPLANTED IN THE LEFT RENAL ARTERY. ON (B)(6) 2022, THE PATIENT PRESENTED WITH AN ACUTE RENAL FAILURE. IT WAS NOT SPECIFIED IF PATIENT HAD OCCLUSIONS IN ONE OR BOTH RENAL ARTERIES. ON (B)(6) 2022, DIALYSIS WAS INITIATED AND REPORTED AS ONGOING. IT WAS ALSO REPORTED THE PHYSICIAN STATED THE UNDERLYING LUNG CANCER CONTRIBUTED TO DEVICE OCCLUSION AND LED TO RENAL FAILURE. THE PATIENT EXPIRED ON (B)(6) 2022 DUE TO LUNG CANCER (REPORTED AS UNRELATED TO THE DEVICES OR PROCEDURE).

  Patient problems: Renal Impairment

  MAUDE report 15712371 ↗
• InjuryJun 23, 2022Obstruction of Flow; Obstruction of Flow

  SUBJECT: (B)(6). AE ONSET DATE: (B)(6) 2020. AE DESCRIPTION: ATHEROSCLEROSIS OF RIGHT RENAL ARTERY WITH OCCLUSION OF RIGHT RENAL STENT. AE OUTCOME: RECOVERED WITH SEQUELAE - ATROPHY OF THE RIGHT KIDNEY DESPITE THE PERFUSION AFTER SECONDARY INTERVENTION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14795352 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESES (TAMBE) IN THE AAA1701 TAMBE PIVOTAL STUDY. ON THE DATE OF THE PROCEDURE, LEFT RENAL ARTERY DISSECTION WAS REPORTED. IT WAS REPORTED THAT THE DISSECTION WAS NOT PRE-EXISTING. THE PRINCIPAL INVESTIGATOR REPORTED THAT THE DISSECTION LIKELY OCCURRED FROM A COMBINATION OF FACTORS, PRIMARILY THE PRE-EXISTING ATHEROSCLEROTIC DISEASE AND PLAQUE IN THE AREA OF STENTING AND THE USE OF THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX). THE PHYSICIAN MADE THE OBSERVATION THAT THE STIFF AND NON-COMPLIANT BALLOON OF THE VBX DEVICE IS, "ACCORDING TO OUR EXPERIENCE, PRONE TO CAUSE DISSECTIONS IN PATIENTS WITH VASCULAR DISEASE". IT WAS NOTED THAT THE EVENT WAS RESOLVED ON THE SAME DAY. MEDTRONIC STENTS WERE PLACED TO TREAT THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 14519476 ↗
• InjuryJan 26, 2021Complete Blockage; Complete Blockage

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020 A PATIENT UNDERWENT THORACOABDOMINAL AORTIC ANEURYSM TREATMENT IN THE (B)(6) CLINICAL STUDY. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS UTILIZED IN THEE RIGHT RENAL ARTERY. ON (B)(6) 2021, THE RIGHT RENAL ARTERY STENT WAS FOUND TO BE SEVERELY STENOSED. ON (B)(6) 2021 A REINTERVENTION TOOK PLACE WHEREBY AN ADDITIONAL STENT WAS PLACED TO TREAT THE STENOSIS.

  Patient problems: Occlusion

  MAUDE report 11233534 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 A PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS A SUBJECT IN THE AAA 17-01 TAMBE CLINICAL TRIAL. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS UTILIZED IN THE LEFT RENAL ARTERY. ON (B)(6) 2020, A TYPE IC ENDOLEAK INVOLVING THE VBX DEVICE IN THE LEFT RENAL ARTERY WAS DISCOVERED AND TREATED BY MEANS OF ANOTHER VBX DEVICE. THE ENDOLEAK WAS RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10891911 ↗

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