GORE VIABAHN VBX Balloon Expandable Endo BXA077902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00733132637539), received between Nov 15, 2017 and Feb 9, 2026 — classified as 3 deaths, 18 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (7 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2026Malposition of Device

  THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE ON (B)(6) 2020, UTILIZING THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) ALONG WITH MULTIPLE VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES IN THE VISCERAL VESSELS. NO ISSUES WERE REPORTED WITH ANY OF THE DEVICES USED DURING THE INITIAL PROCEDURE. ON (B)(6) 2026, DURING A FOLLOW-UP IMAGING, A TYPE 1C ENDOLEAK WAS OBSERVED, INVOLVING THE LEFT RENAL ARTERY. IT WAS REPORTED THE PATIENT WILL UNDERGO TREATMENT ON (B)(6) 2026, IN WHICH AN ADDITIONAL STENT WILL BE IMPLANTED IN THE RENAL ARTERY. PHYSICIAN ATTRIBUTES THIS ENDOLEAK DUE TO THE RENAL STENT NOT IN FAR ENOUGH.

  Patient problems: Clinical Endoleak

  MAUDE report 24294788 ↗
• InjuryOct 15, 2025Obstruction of Flow; Obstruction of Flow

  A STUDY ALERT FROM THE PIVOTAL AAA 17-01 (TAMBE) CLINICAL STUDY WAS RECEIVED: ON (B)(6) 2022, A TAMBE PROCEDURE WAS PERFORMED AND 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) WERE USED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. TWO OR MORE VBX DEVICES WERE IMPLANTED THE SUPERIOR MESENTERIC ARTERY (SMA), LEFT RENAL ARTERY, RIGHT RENAL ARTERY, AND ONE VBX DEVICE IN CELIAC ARTERY. ON (B)(6) 2024, THE PATIENT WAS REPORTED TO BE IN A LOCAL HOSPITAL WITH RENAL FAILURE AND IS ON DIALYSIS. NO INTERVENTION WAS REPORTED INVOLVING THE STUDY DEVICE. AS STATED, PATIENT RECORDS WERE REQUESTED. UPDATED INFORMATION STATES A NON-CONTRAST CT SCAN THAT WAS DONE AT AN OUTSIDE HOSPITAL BUT THEY COULD NOT DETERMINE ANYTHING ABOUT THE RENAL STENTS FROM THAT SCAN. THE PHYSICIAN DID NOT WANT TO GIVE PATIENT CONTRAST FOR THE CT SCAN DUE TO THE RENAL FAILURE. ULTRASOUND WAS SUGGESTED, BUT NO FURTHER INFORMATION AT THIS TIME. FIVE VBX DEVICES WERE IMPLANTED. (B)(6) RIGHT RENAL ARTERY FIRST DISTAL EXTENSION (B)(6) RIGHT RENAL ARTERY MOST PROXIMA

  Patient problems: Obstruction/Occlusion

  MAUDE report 23292689 ↗
• InjuryMar 28, 2025Partial Blockage; Partial Blockage

  THE FOLLOWING WAS REPORTED TO GORE ON (B)(6) 2025 FROM THE AAA-1701 MEDRIO STUDY DATABASE: ON (B)(6) 2023, THIS 63-YEAR-OLD MALE PATIENT UNDERWENT AN ENDOVASCULAR PERCUTANEOUS PROCEDURE FOR A TYPE IV AORTIC ANEURYSM. A TAMBE DEVICE WAS PLANNED FOR THIS PATIENT. THE LEFT RENAL ARTERY WAS TREATED WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICE. THE PATIENT WAS TREATED WITH MULTIPLE DEVICES; ALL TAMBE SYSTEM COMPONENTS WERE SUCCESSFULLY TRACKED FROM THE ACCESS SITE TO THE INTENDED IMPLANTATION SITE AND RELEASED FROM DELIVERY CATHETERS SUCCESSFULLY. ON (B)(6) 2024, THIS PATIENT WAS NOTED TO HAVE LEFT RENAL ARTERY OCCLUSION. IT IS NOTED AS RELATED TO THE DEVICE AND TREATMENT WAS REQUIRED. ON (B)(6) 2024, THE PATIENT UNDERWENT SUCCESSFUL ENDOVASCULAR RECANALIZATION OF THE LEFT RENAL ARTERY WITH THROMBECTOMY AND BALLOON ANGIOPLASTY. THE ADVERSE EVENT WAS NOTED AS RESULTING IN RENAL FAILURE, BUT THE PATIENT DID NOT RECEIVE DIALYSIS. THE ADVERSE EVENT WAS NOTED AS RESOLVED WITH SEQUELAE ON (B)(6) 2024. THE PATIENT DISCHARGED FROM THE HOSPITAL ON (B)(6)2024. ON (B)(6) 2024, THIS PATIENT WAS NOTED TO HAVE LEFT RENAL ARTERY STENOSIS. IT IS NOTED THAT IT IS RELATED TO THE STU

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21725186 ↗
• InjuryFeb 13, 2025Partial Blockage; Partial Blockage

  A STUDY ALERT FROM PIVOTAL AAA17-01 (TAMBE) CLINICAL STUDY WAS RECEIVED: DEVICE COMPRESSION IS AT THE TRANSITION OF BRIDGING STENT TO THE NATIVE RENAL, SO THIS LOCATION OF THIS COMPRESSION AFFECTS BOTH COMPONENTS. ON (B)(6) 2020, 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. TWO VBX DEVICE/STENT WERE IMPLANTED IN THE RENAL ARTERY. DURING A FOLLOW-UP ON (B)(6) 2025, IMAGING WAS PERFORMED. OBSERVED DEVICE COMPRESSION AT THE TRANSITION OF BRIDGING STENT TO THE NATIVE RENAL, SO THIS LOCATION OF THIS COMPRESSION AFFECTS BOTH VBX DEVICE/STENTS IN THE RENAL ARTERY. THERE WERE NO REPORTED FRACTURES, AND THE BRANCH DEVICES REMAIN PATENT. NO INTERVENTION WAS REPORTED. THE PATIENT IS SCHEDULED FOR A RIGHT RENAL ANGIOGRAM ON (B)(6) 2025

  Patient problems: Stenosis

  MAUDE report 21378439 ↗
• InjuryFeb 13, 2025Partial Blockage; Partial Blockage

  A STUDY ALERT FROM PIVOTAL AAA17-01 (TAMBE) CLINICAL STUDY WAS RECEIVED: DEVICE COMPRESSION IS AT THE TRANSITION OF BRIDGING STENT TO THE NATIVE RENAL, SO THIS LOCATION OF THIS COMPRESSION AFFECTS BOTH COMPONENTS. ON (B)(6) 2020, 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. TWO VBX DEVICE/STENT WERE IMPLANTED IN THE RENAL ARTERY. DURING A FOLLOW-UP ON (B)(6) 2025, IMAGING WAS PERFORMED. OBSERVED DEVICE COMPRESSION AT THE TRANSITION OF BRIDGING STENT TO THE NATIVE RENAL, SO THIS LOCATION OF THIS COMPRESSION AFFECTS BOTH VBX DEVICE/STENTS IN THE RENAL ARTERY. THERE WERE NO REPORTED FRACTURES, AND THE BRANCH DEVICES REMAIN PATENT. NO INTERVENTION WAS REPORTED. THE PATIENT IS SCHEDULED FOR A RIGHT RENAL ANGIOGRAM ON (B)(6) 2025.

  Patient problems: Stenosis

  MAUDE report 21378377 ↗
• MalfunctionJan 13, 2025Material Integrity Problem; Material Integrity Problem

  A STUDY ALERT FROM THE PIVOTAL AAA 17-01 (TAMBE) CLINICAL STUDY WAS RECEIVED: ON (B)(6) 2022, 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 JULY 29, 2024, DURING A 24-MONTH FOLLOW-UP, COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING WAS PERFORMED. DEVICE OVALIZATION OF THE VBX DEVICE IN THE RIGHT RENAL ARTERY SIDE BRANCH COMPONENT WITHIN THE AORTA JUST DISTAL TO THE RIGHT RENAL ARTERY PORTAL GOLD RING WAS OBSERVED. DURING THIS FOLLOW-UP, ALL BRANCH DEVICES WERE NOTED AS PATENT AND THERE WERE NO VBX DEVICE WIRE FRACTURES REPORTED. NO REINTERVENTION IS SCHEDULED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138220 ↗
• MalfunctionNov 25, 2024Material Integrity Problem; Material Integrity Problem

  A STUDY ALERT FROM THE PIVOTAL AAA 17-01 (TAMBE) CLINICAL STUDY WAS RECEIVED: ON (B)(6) 2021, THE PATIENT UNDERWENT A THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) ENDOVASCULAR PROCEDURE TO TREAT AN AORTIC ANEURYSM USING A 7 MM X 79 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) IN THE RIGHT RENAL ARTERY SIDE BRANCH MOST PROXIMAL WITHIN THE PORTAL. ON (B)(6) 2023, DURING A 24 MONTH FOLLOW-UP, COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING WAS PERFORMED. DEVICE OVALIZATION OF THE RIGHT RENAL ARTERY SIDE BRANCH COMPONENT WITHIN THE AORTA JUST DISTAL TO THE PORTAL GOLD RING WAS OBSERVED. ON (B)(6) 2024, DURING THE 36 MONTHS FOLLOW UP, CTA WAS PERFORMED AND DEVICE OVALIZATION OF THE RIGHT RENAL ARTERY SIDE BRANCH COMPONENT WITHIN THE AORTA JUST DISTAL TO THE PORTAL GOLD RING WAS OBSERVED AGAIN. ADDITIONALLY, THERE WAS A WIRE FRACTURE OF THE TAMBE AORTIC COMPONENT (CASE (B)(4)) AND OVALIZATION OF THE VBX DEVICE IN THE CELIAC ARTERY (CASE (B)(4)) OBSERVED. REPORTEDLY, ALL BRANCH DEVICES WERE NOTED AS PATENT AND THERE WERE NO VBX DEVICE WIRE FRACTURES REPORTED. THE STUDY PATIENT IS ASYMPTOMATIC AND NO INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20773062 ↗
• MalfunctionOct 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING INFORMATION WAS PROVIDED TO GORE FROM A CLINICAL STUDY: ON (B)(6) 2022, A STUDY PATIENT UNDERWENT A AAA PROCEDURE. DURING THE PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES) WERE IMPLANTED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. DURING AN UNSCHEDULED VISIT ON (B)(6) 2022, CTA IMAGING WAS DONE AND DEVICE OVALIZATION (COMPRESSION) OF THE PROXIMAL END OF THE LEFT RENAL ARTERY SIDE BRANCH COMPONENT WAS REPORTED. IT WAS ALSO REPORTED ALL OF THE IMPLANTED BRANCH VBX DEVICES WERE ASSESSED AS PATENT. NO KINKS OR FRACTURES WERE OBSERVED. THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF VISIT AND NO INTERVENTION WAS PERFORMED OR PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355043 ↗
• InjurySep 4, 2024Device Slipped; Migration; Device Slipped; Migration

  THE FOLLOWING DETAILS WERE REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 5 DESCENDING AORTIC ANEURYSM. THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® ABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THE COMPLETE TAMBE SYSTEM IS COMPRISED OF THE TAMBE AORTIC COMPONENT, THE BRANCH COMPONENTS (GORE® VIABAHN® (VBX) BALLOON EXPANDABLE ENDOPROSTHESIS), A DISTAL BIFURCATED COMPONENT (GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS COMPONENT) AND CONTRALATERAL LEGS (GORE® EXCLUDER® CONTRALATERAL LEGS). THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE THE PATIENT UNDERWENT FOLLOW-UP IMAGING AND THE PATIENT WAS DETERMINED TO HAVE A PSEUDOANEURYM IN THE BRACHIAL ARTERY, WHICH IS BELIEVED TO BE PROCEDURE, NOT DEVICE RELATED. ON (B)(6) 2024, THE PATIENT UNDERWENT RE-INTERVENTION AND THE GORE® EXCLUDER® CONTRALTERAL LEG COMPONENTS IN THE COMMON ILIAC ARTERY EXTENDED FROM THE TAMBE SYSTEM WERE BILATERALLY EXTENDED WITH VIABAHN® (VBX) BALLOON EXPANDABLE ENDOPROSTHESIS TO THE INTERNAL ILIAC ARTERIES. THE PHYSICIAN THEN INTUBATED THE PATIENT AS THERE HAD BEEN A LOT OF BLOOD LOSS (AMOUNT UNKNOWN) FROM THE PSEUDOANERYSM BRACHIAL ARTERY BLEED IN THE IN THE LEFT U

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

  MAUDE report 20138206 ↗
• MalfunctionApr 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INFORMATION WAS RECEIVED FROM A CLINICAL STUDY: ON (B)(6) 2019, A 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. DURING PATIENT FOLLOW-UP ON (B)(6) 2023, IMAGING SHOWED A COMPRESSED LEFT RENAL ARTERY SIDE BRANCH COMPONENT. AS REPORTED, THE VBX DEVICE IMPLANTED IN THE LEFT RENAL ARTERY THAT WAS MOST PROXIMAL WITHIN THE PORTAL SHOW THE COMPRESSION. ACTION TAKEN WAS OBSERVATION WITH THE POSSIBILITY OF RE-EXPANSION OF DEVICE AT A LATER DATE. IT WAS ALSO REPORTED THE VBX DEVICE REMAINS PATENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19072098 ↗
• InjuryMar 4, 2024Activation Problem; Device Stenosis; Activation Problem; Device Stenosis

  ON (B)(6) 2024, THE PATIENT WAS TREATED FOR ABDOMINAL AORTIC ANEURYSM. AFTER IMPLANTING SEVERAL AORTIC DEVICES TO TREAT THE ANEURYSM IN THE AORTA, THE PHYSICIAN ALSO WANTED TO EXTEND DEEP INTO THE INTERNAL ILIAC TO TREAT AN ANEURYSM IN THAT VESSEL. AFTER IMPLANTING AN ILIAC BRANCH ENDOPROSTHESIS, THE PHYSICIAN THEN IMPLANTED A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. WHILE DEPLOYING THE DEVICE, THE LAST STENT RING DID NOT OPEN FULLY. THE PHYSICIAN USED A SECONDARY BALLOON TO COMPLETE FULL EXPANSION OF THE STENT GRAFT, ALSO CAUSING A SMALL PERFORATION OF THE VESSEL. THE PHYSICIAN THEN COILED THE HYPOGASTRIC INTENTIONALLY, AND THE ISSUE WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Foreign Body Embolism; Reduced Blood Flow

  MAUDE report 18833155 ↗
• InjuryJul 5, 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 17261145 ↗
• DeathMay 4, 2023Complete Blockage; Complete Blockage

  ON (B)(6) 2023, THE PATIENT ARRIVED ABOUT 10AM WITH ABDOMINAL PAIN, NAUSEA, AND VOMITING. CT REVEALED OCCLUSION OF SMA AND BILATERAL RENAL STENTS. VASCULAR SURGEON WAS UNAVAILABLE, REQUIRING PATIENT TO TRANSFER TO ANOTHER FACILITY. UPON ARRIVAL BY 10PM, THE PATIENT HAD ABOUT 12 HOURS OF WARM ISCHEMIA TIME FOR BOTH KIDNEYS AND WAS NOT MAKING URINE. THE PATIENT WAS GIVEN DILAUDID®. PATIENT CONTINUED TO HAVE PAIN AND WITH CTA FINDINGS, URGENT EXPLORATION WAS IMMEDIATELY SCHEDULED. THE PATIENT WAS INFORMED IF VIABLE BOWEL IS FOUND, A BYPASS WILL BE DONE, AND A SECOND LOOK WILL BE NECESSARY. HEMODIALYSIS WAS ALSO NEEDED. AS REPORTED, PATIENT HAD BEEN EXPERIENCING SEVERE MUSCLE PAIN OVER THE LAST SEVERAL WEEKS, LEADING TO CESSATION OF HIS STATIN AND PREDNISONE THERAPY. HE WAS ALSO TAKEN OFF PLAVIX. CARDIOLOGIST NOTES STATED AORTIC STENOSIS WAS SOMEWHAT SIGNIFICANT, WITH EJECTION FRACTION OF 60%. IN MARCH 2023, PATIENT HAD A CT ANGIOGRAM OF THE TAMBE DEVICE AND ALL FOUR BRANCH DEVICES TO THE SMA, CELIAC AND BILATERAL RENAL ARTERIES WERE PATENT AT THAT TIME. ON (B)(6) 2023, EXPLORATORY LAPAROTOMY AND BYPASS PROCEDURE WERE DONE. A FOLEY WAS PLACED AND THERE WAS ABOUT 40 OR 50 CC OF DARK YEL

  Patient problems: Renal Failure; Thrombosis/Thrombus

  MAUDE report 16873446 ↗
• DeathMay 4, 2023Complete Blockage; Complete Blockage

  ON (B)(6) 2023, THE PATIENT ARRIVED ABOUT 10AM WITH ABDOMINAL PAIN, NAUSEA, AND VOMITING. CT REVEALED OCCLUSION OF SMA AND BILATERAL RENAL STENTS. VASCULAR SURGEON WAS UNAVAILABLE, REQUIRING PATIENT TO TRANSFER TO ANOTHER FACILITY. UPON ARRIVAL BY 10PM, THE PATIENT HAD ABOUT 12 HOURS OF WARM ISCHEMIA TIME FOR BOTH KIDNEYS AND WAS NOT MAKING URINE. THE PATIENT WAS GIVEN DILAUDID®. PATIENT CONTINUED TO HAVE PAIN AND WITH CTA FINDINGS, URGENT EXPLORATION WAS IMMEDIATELY SCHEDULED. THE PATIENT WAS INFORMED IF VIABLE BOWEL IS FOUND, A BYPASS WILL BE DONE, AND A SECOND LOOK WILL BE NECESSARY. HEMODIALYSIS WAS ALSO NEEDED. AS REPORTED, PATIENT HAD BEEN EXPERIENCING SEVERE MUSCLE PAIN OVER THE LAST SEVERAL WEEKS, LEADING TO CESSATION OF HIS STATIN AND PREDNISONE THERAPY. HE WAS ALSO TAKEN OFF PLAVIX. CARDIOLOGIST NOTES STATED AORTIC STENOSIS WAS SOMEWHAT SIGNIFICANT, WITH EJECTION FRACTION OF 60%. IN (B)(6) 2023, PATIENT HAD A CT ANGIOGRAM OF THE TAMBE DEVICE AND ALL FOUR BRANCH DEVICES TO THE SMA, CELIAC AND BILATERAL RENAL ARTERIES WERE PATENT AT THAT TIME. ON (B)(6) 2023, EXPLORATORY LAPAROTOMY AND BYPASS PROCEDURE WERE DONE. A FOLEY WAS PLACED AND THERE WAS ABOUT 40 OR 50 CC OF DARK YE

  Patient problems: Renal Failure; Thrombosis/Thrombus

  MAUDE report 16873344 ↗
• InjuryMar 18, 2023Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2021, A STUDY PATIENT HAD A AAA PROCEDURE. DURING THIS PROCEDURE, SEVERAL GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE USED AS BRANCH COMPONENTS IN THE VISCERAL ARTERIES. VBX DEVICES WERE IMPLANTED IN OVERLAPPED FASHION, TWO DEVICES IN THE CELIAC ARTERY AND TWO DEVICES IN THE RIGHT RENAL ARTERY. ONE VBX DEVICE WAS IMPLANTED IN THE LEFT RENAL ARTERY AND ONE IN THE SUPERIOR MESENTERIC ARTERY (SMA). ON (B)(6) 2023, A LEFT RENAL ARTERY BRANCH OCCLUSION WAS NOTED. NO INTERVENTION WAS REPORTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16569690 ↗
• 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 15712226 ↗
• InjuryOct 13, 2022Complete Blockage; Complete Blockage

  ON (B)(6) 2022, A STUDY PATIENT WAS IMPLANTED WITH TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) THAT WERE OVERLAPPED IN THE RIGHT RENAL ARTERY AS A SIDE BRANCH. THE TWO VBX DEVICES WERE OVERLAPPED AND IMPLANTED AS BRANCH DEVICES IN A AAA PROCEDURE. DURING A FOLLOW-UP ON (B)(6) 2022, THE RIGHT RENAL ARTERY STENT GRAFT OCCLUSION WAS OBSERVED. AS REPORTED, THIS WAS A TOTAL DEVICE OCCLUSION. BALLOON ANGIOPLASTY, MECHANICAL THROMBECTOMY AND THROMBOLYTIC THERAPY WERE ADMINISTERED TO RESTORE BLOOD FLOW. THE PATIENT TOLERATED THE INTERVENTION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15601188 ↗
• InjuryAug 22, 2022Partial Blockage; Obstruction of Flow; Partial Blockage; Obstruction of Flow

  THE FOLLOWING INFORMATION WAS RECEIVED BY GORE FROM THE MEDRIO DATABASE IN REGARDS TO TAMBE CLINICAL STUDY AAA 17-01: ON (B)(6) 2021, A PATIENT RECEIVED TREATMENT FOR A THORACOABDOMINAL AORTIC ANEURYSM WITH THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS BEING IMPLANTED WITHIN THE RIGHT RENAL ARTERY. ON (B)(6) 2022, OCCLUSION WAS OBSERVED WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS LOCATED IN THE RIGHT RENAL ARTERY. NO TREATMENT HAS BEEN RENDERED.

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 15266535 ↗
• InjuryJun 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2020 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE), GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX), GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENTS, AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS IN THE AAA1701 TAMBE PIVOTAL STUDY. ON (B)(6) 2021 A TYPE III ENDOLEAK WAS OBSERVED. IT IS UNKNOWN AT THIS TIME WHICH DEVICE(S) THE ENDOLEAK ORIGINATED FROM. IT WAS REPORTED THAT THE PATIENT PASSED AWAY FROM COVID PRIOR TO THE ENDOLEAK BEING TREATED.

  Patient problems: Insufficient Information

  MAUDE report 14795351 ↗
• InjuryJun 23, 2022Obstruction of Flow; Obstruction of Flow

  (B)(6).

  Patient problems: Obstruction/Occlusion

  MAUDE report 14794562 ↗
• InjuryJun 23, 2022Obstruction of Flow; Obstruction of Flow

  SUBJECT: (B)(4), ONSET DATE: (B)(6) 2022, DESCRIPTION: RIGHT RENAL ARTERY STENOSIS, OUTCOME: NOT RECOVERED/RESOLVED - TREATMENT REQUIRED. ONSET DATE: (B)(6) 2022, DESCRIPTION: RIGHT RENAL ARTERY THROMBOSIS, OUTCOME: NOT RECOVERED/RESOLVED - TREATMENT REQUIRED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14789468 ↗
• InjuryJun 22, 2022Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING AE WAS RECEIVED FROM MEDRIO. SUBJECT: (B)(6). SITE: (B)(6). FORM: FORM 22 - ADVERSE EVENT, VISIT: ADVERSE EVENT - 01, AE: OCCLUDED RIGHT RENAL ARTERY. AE ONSET: (B)(6) 2022. TWO VBX DEVICES ARE IN THE PATIENT'S RIGHT RENAL ARTERY. IT WAS NOTED THAT TREATMENT IS/WAS REQUIRED. DATE OF PROCEDURE/IMPLANT WAS (B)(6) 2022.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14776864 ↗
• DeathMay 25, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO GORE THAT THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS INVOLVED IN AN ADVERSE EVENT OF A STENOSIS/THROMBOSIS WITHIN THE RIGHT RENAL ARTERY WITHIN THE (B)(6) CLINICAL STUDY. PATIENT/ADVERSE EVENT INFORMATION IS AS FOLLOWS: 1701-385-002, A/E 13 , BXA077902A/ (B)(4) -IMPLANTED IN THE RIGHT RENAL ARTERY, MOST PROXIMAL WITHIN THE PORTAL PROCEDURE DONE (B)(6) 2020 ADVERSE EVENT ON (B)(6) 2022-ACUTE ON CHRONIC KIDNEY INJURY, STUDY DEVICE RELATED. APPEARS TO BE RELATED TO AE11 AS AE11 HAS A RESOLUTION DATE OF (B)(6) 2022 AND AE13 HAS A RESOLUTION DATE OF (B)(6) 2022 WITH OUTCOME OF AE LISTED AS DEATH.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14500134 ↗
• InjuryJan 21, 2021Complete Blockage; Complete Blockage

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021 A PATIENT UNDERWENT ENDOVASCULAR TREATMENT IN THE TAMBE CLINICAL TRIAL. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS UTILIZED AS A BRANCH VESSEL STENT IN THE LEFT RENAL ARTERY. AFTER THE STENT WAS DEPLOYED, IT BECAME OCCLUDED WITH THROMBUS. THIS OCCLUSION WAS TREATED BY MEANS OF THROMBOLYSIS AND BALLOON ANGIOPLASTY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 11207709 ↗
• MalfunctionNov 6, 2020Fracture; Fracture

  DURING A COMPLEX THORACOABDOMINAL ANEURYSM PROCEDURE, A 7FR COOK SHEATH WAS USED TO ADVANCE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) TO THE SUPERIOR MESENTERIC ARTERY. AS REPORTED, THE PATIENT HAS A VERY TORTUOUS ANATOMY. THE VBX DEVICE WAS PLACED AND DEPLOYED AT THE INTENDED TREATMENT SITE WITH NO ISSUES. HOWEVER, UPON WITHDRAWAL OF THE DELIVERY CATHETER OVER THE .035 ROSEN WIRE THE PROXIMAL PART OF THE VBX CATHETER JUST BELOW THE HUB TORE APART FROM THE REST OF THE CATHETER. THE ENTIRE SHEATH WITH THE BROKEN VBX DELIVERY CATHETER INSIDE, WAS WITHDRAWN FROM THE PATIENT AS ONE UNIT. THE SHEATH WAS THEN REPLACED WITH AN 8FR TERUMO SHEATH AND A NEW DEVICE WAS PLACED. THE PROCEDURE ENDED WITH GOOD RESULTS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10804578 ↗

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