GORE VIABAHN VBX Balloon Expandable Endo BXA075902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00733132637294), received between Nov 14, 2019 and Mar 24, 2026 — classified as 1 death, 16 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (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 25 most recent of 25 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 24676393 ↗
• 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. 25743768 RIGHT RENAL ARTERY FIRST DISTAL EXTENSION. 25869696 RIGHT RENAL ARTERY MOST PR

  Patient problems: Obstruction/Occlusion

  MAUDE report 23292575 ↗
• MalfunctionFeb 3, 2025Dent in Material; Dent in Material

  THE FOLLOWING WAS RECEIVED FROM A CLINICAL STUDY: ON (B)(6) 2020, A STUDY PATIENT UNDERWENT A AAA PROCEDURE AND A TAMBE DEVICE WAS IMPLANTED. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE USED AS BRANCHED DEVICES IN THE VISCERAL ARTERIES. DURING A 48-MONTH FOLLOW-UP ON (B)(6) 2024, CTA IMAGES WERE COMPLETED. A WIRE FRACTURE OF THE TAMBE AORTIC COMPONENT WAS OBSERVED. THE FRACTURE APPEARED TO BE THE FIRST STENT ROW DISTAL TO THE RIGHT RENAL ARTERY PORTAL AND IS POSTERIOR IN NATURE. OTHER OBSERVATIONS REPORTED WERE: VBX DEVICE OVALIZATION OF THE RIGHT RENAL ARTERY SIDE BRANCH COMPONENT WITHIN THE AORTA JUST DISTAL TO THE PORTAL GOLD RING. VBX DEVICE OVALIZATION OF THE CELIAC ARTERY SIDE BRANCH COMPONENT WITHIN THE AORTA JUST PROXIMAL OF THE CELIAC ARTERY ORIGIN. AS REPORTED, THE BRANCH DEVICES REMAIN PATENT. NO INTERVENTION WAS REPORTED OR PLANNED FOR THE DEVICE OVALIZATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293844 ↗
• MalfunctionFeb 3, 2025Dent in Material; Dent in Material

  THE FOLLOWING WAS RECEIVED FROM A CLINICAL STUDY: ON (B)(6) 2020, A STUDY PATIENT UNDERWENT A AAA PROCEDURE AND A TAMBE DEVICE WAS IMPLANTED. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE USED AS BRANCHED DEVICES IN THE VISCERAL ARTERIES. DURING A 48-MONTH FOLLOW-UP ON (B)(6) 2024, CTA IMAGES WERE COMPLETED. A WIRE FRACTURE OF THE TAMBE AORTIC COMPONENT WAS OBSERVED. THE FRACTURE APPEARED TO BE THE FIRST STENT ROW DISTAL TO THE RIGHT RENAL ARTERY PORTAL AND IS POSTERIOR IN NATURE. OTHER OBSERVATIONS REPORTED WERE: VBX DEVICE OVALIZATION OF THE RIGHT RENAL ARTERY SIDE BRANCH COMPONENT WITHIN THE AORTA JUST DISTAL TO THE PORTAL GOLD RING. VBX DEVICE OVALIZATION OF THE CELIAC ARTERY SIDE BRANCH COMPONENT WITHIN THE AORTA JUST PROXIMAL OF THE CELIAC ARTERY ORIGIN. AS REPORTED, THE BRANCH DEVICES REMAIN PATENT. NO INTERVENTION WAS REPORTED OR PLANNED FOR THE DEVICE OVALIZATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293781 ↗
• MalfunctionNov 18, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING WAS RECEIVED FROM A CLINICAL STUDY: ON (B)(6) 2020, A STUDY PATIENT UNDERWENT A AAA PROCEDURE AND A TAMBE DEVICE WAS IMPLANTED. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE USED AS BRANCHED DEVICES IN THE VISCERAL ARTERIES. IMAGING PERFORMED ON (B)(6) 2022 AT 24-MONTHS, FOLLOW-UP SHOWED THE DISTAL END OF THE THIRD RENAL ARTERY DEVICE (EVERFLEX BMS) REMAINS OCCLUDED, WITH BLOOD FLOW TO OTHER RIGHT RENAL ARTERY BRANCHES. THERE ALSO APPEARED TO BE A SMALL AMOUNT OF COLLATERAL FLOW DISTAL OF THE OCCLUSION. ALSO OBSERVED WAS OVALIZATION OF THE RIGHT RENAL ARTERY DEVICE, JUST DISTAL OF THE PORTAL GOLD RINGS. THERE APPEARED TO BE FLOW WITHIN THE RIGHT RENAL ARTERY NEAR THE OVERLAP BETWEEN THE 2ND AND 3RD RIGHT RENAL ARTERY SIDE BRANCH COMPONENTS. NO FRACTURES WERE OBSERVED AND ALL THE BRANCH DEVICES REMAIN PATENT. PATIENT APPEARS TO BE ASYMPTOMATIC AND NO INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20709014 ↗
• DeathSep 4, 2024Fluid/Blood Leak; Migration; Fluid/Blood Leak; Migration

  THE FOLLOWING DETAILS WERE REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 5 ABDOMINAL AORTIC ANEURYSM. THE PATIENT¿S IS REPORTED TO HAVE A PRE-EXISTING AAA S/P Y-GRAFT WHICH WAS IMPLANTED IN 2004. PRESENTLY, THE PHYSICIAN REPORTS THE ANEURYSM HAS DILATED TO 4.65CM WITH DILATION OF THE SUPRARENAL ARTERY MEASURING 5CM AND AN AREA AT THE RENAL ARTERIES THAT BLOSSOMS OUT TO APPROXIMATELY 9CM. 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 WHICH ARE GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES), A DISTAL BIFURCATED COMPONENT (GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT) AND CONTRALATERAL LEGS (GORE® EXCLUDER® CONTRALATERAL LEGS). IT WAS REPORTED THAT ALL PROXIMAL AND BRANCH DEVICES HAD BEEN SUCCESSFULLY DEPLOYED AS INTENDED WITH TECHNICAL SUCCESS (WITH EXCEPTION OF THE FINAL BRANCH DEVICE WHICH WAS ADVANCED BUT NOT YET DEPLOYED). IT WAS REPORTED THAT UPON DEPLOYMENT OF THE DISTAL END OF THE TAMBE AORTIC COMPONENT, THE VBX DEVICES DEPLOYED IN THE RIGHT RENAL ARTERY BECAME DIS

  Patient problems: Clinical Endoleak; Multiple Organ Dysfunction Syndrome; Stenosis

  MAUDE report 20141333 ↗
• InjuryJun 4, 2024Complete Blockage; Complete Blockage

  THE FOLLOWING WAS REPORTED TO GORE 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 WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES) AS BRANCH DEVICE COMPONENTS. ON (B)(6) 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 (B)(6) 2022, THE PATIENT BEGAN IN-PATIENT HEMODIALYSIS AND IT WAS STOPPED ON (B)(6) 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 19464110 ↗
• MalfunctionApr 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024 THE PATIENT UNDERWENT TREATMENT FOR A HEAVILY CALCIFIED LEFT ILIAC ARTERY USING A 7 MM X 59 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (GORE® VBX DEVICE). IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT UP AND OVER THE BIFURCATION FROM THE RIGHT GROIN USING A 7F COOK® FLEXOR® ANSEL GUIDING SHEATH OVER AN AMPLATZ SUPER STIFF¿ GUIDEWIRE (SIZE NOT PROVIDED). REPORTEDLY, THE DELIVERY CATHETER WOULD NOT ADVANCE PAST THE TARGET LESION. IT IS UNKNOWN IF THE TARGET LESION WAS PRE-DILATED. THE DECISION WAS MADE TO WITHDRAW THE DELIVERY CATHETER. DURING WITHDRAWAL, THE DELIVERY CATHETER WAS PULLED BACK THROUGH THE INTRODUCER SHEATH, AND THE ENDOPROSTHESIS DISLODGED FROM THE CATHETER. IT WAS REPORTED THE PROCEDURE INCLUDED A PLANNED ENDARTERECTOMY ON THE LEFT SIDE, THEREFORE A GOOSE NECK SNARE WAS ADVANCED IN THE OPEN ARTERY AND USED TO REMOVE THE DISLODGED ENDOPROSTHESIS FROM THE PATIENT. THE PHYSICIAN SUSPECTS THE ENDOPROSTHESIS GOT CAUGHT ON THE EDGE OF THE INTRODUCER SHEATH CAUSING THE DISLODGMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER SAME SIZE GORE® VBX DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177212 ↗
• InjurySep 25, 2023Separation Problem; Separation Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE AS A BRANCH DEVICE IN THE CELIAC ARTERY DURING TREATMENT OF AN AORTIC ANEURYSM. THE PHYSICIAN GAINED ACCESS FROM THE ARM WITH A COOK MEDICAL ROSEN GUIDE WIRE. A ZENITH® T-BRANCH¿ THORACOABDOMINAL ENDOVASCULAR GRAFT WAS PLACED ON AN UNKNOWN DATE TO TREAT THE AORTIC ANEURYSM. DURING THE DEPLOYMENT OF THE VBX DEVICE, THE PHYSICIAN WAS UNABLE TO GET A GOOD SEAL DUE TO THE ALIGNMENT OF THE ZENITH® T-BRANCH¿ THORACOABDOMINAL ENDOVASCULAR GRAFT AND VBX DEVICE INTO THE ARTERY. WITH THE INABILITY TO ALIGN THE ZENITH® T-BRANCH¿ THORACOABDOMINAL ENDOVASCULAR GRAFT AND VBX DEVICE PROPERLY, IT CREATED A SEPARATION OF THE BRIDGING STENT GRAFT AND THE MAIN BODY T-BRANCH (TYPE III ENDOLEAK). A REINTERVENTION WAS PERFORMED ON (B)(6) 2023, TO RELINE THE VBX DEVICE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17808957 ↗
• InjuryAug 15, 2023Complete Blockage; Complete Blockage

  ON (B)(6) 2022, A STUDY PATIENT UNDERWENT A AAA PROCEDURE. DURING THE PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE(S)) WERE UTILIZED AS BRANCH DEVICES. TWO VBX DEVICES WERE IMPLANTED IN AN OVERLAPPED FASHION, AS ONE UNIT IN THE LEFT RENAL ARTERY. ON (B)(6) 2023, LEFT RENAL ARTERY THROMBOSIS WAS OBSERVED. ACUTE ACUTE KIDNEY FAILURE WAS LISTED AS SECONDARY TO OCCLUSION. THE ADVERSE EVENT RESULTED IN IN-PATIENT HOSPITALIZATION. ON (B)(6) 2023, LEFT RENAL ARTERY SUCTION THROMBECTOMY AND STENT PLACEMENT WERE PERFORMED DURING REINTERVENTION. PATENCY WAS RESTORED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17551046 ↗
• MalfunctionDec 5, 2022Separation Problem; Separation Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT WAS BEING TREATED FOR STENOTIC OCCLUSIVE DISEASE IN THE ILIAC ARTERY USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. A CONTRALATERAL APPROACH FROM THE ACCESS SITE IN THE RIGHT COMMON FEMORAL ARTERY WAS TAKEN USING A PINNACLE® DESTINATION® GUIDING SHEATH. THE VBX DEVICE MET RESISTANCE DURING MULTIPLE ATTEMPTS TO ADVANCE TO THE TARGET TREATMENT SITE CAUSE UNKNOWN. IT WAS NOTED THE ILIAC ARTERY WAS NOT PRE DILATATED. THE DEVICE WAS ATTEMPTED TO BE WITHDRAWN THROUGH THE SHEATH. DURING WITHDRAWAL THE STENT GRAFT CAUGHT ON THE EDGE OF THE SHEATH PARTIALLY DEPLOYED AND COMPLETELY SEPARATED FROM THE CATHETER. THE PHYSICIAN STATED HIS SUSPECTED CAUSE OF THE DEVICE SEPARATING WAS WITHDRAWING IT INTO THE SHEATH. THE STENT GRAFT REPORTEDLY WAS ABLE TO BE DEPLOYED BY ADVANCING AND INFLATING A BALLOON INTO THE PARTIALLY DEPLOYED DEVICE. THE DEVICE WAS IMPLANTED IN THE COMMON ILIAC ARTERY. ANOTHER GORE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921070 ↗
• InjuryOct 7, 2022Complete Blockage; Complete Blockage

  ON (B)(6) 2021, A PATIENT PARTICIPATING IN A STUDY RECEIVED TREATMENT FOR A THORACOABDOMINAL AORTIC ANEURYSM. DURING TREATMENT, A TWO 7 X 59 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE OVERLAPPED AND IMPLANTED IN LEFT RENAL ARTERY. ONE VBX DEVICE WAS IMPLANTED MOST PROXIMAL WITHIN THE PORTAL AND VBX DEVICE WAS IMPLANTED AS FIRST DISTAL EXTENSION. ON (B)(6) 2022, PATIENT FOLLOW-UP SURVEILLANCE REVEALED HIGH RENAL VELOCITIES BILATERALLY AND THE SURVEILLANCE CT SCAN SUGGESTED A LEFT RENAL STENOSIS DISTAL TO THE BRANCH. ANGIOGRAM REVEALED NO RIGHT RENAL STENOSIS. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED DUE TO THE DISTAL LEFT RENAL ARTERY STENOTIC LESION. NO RENAL FUNCTION DETERIORATION WAS OBSERVED. PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Stenosis

  MAUDE report 15567494 ↗
• InjurySep 7, 2022Positioning Problem; Positioning Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS INTENDED FOR USE IN THE COMMON ILIAC ARTERY FOR TREATMENT BILATERAL OCCLUSIVE DISEASE. HOWEVER, AFTER THE VBX DEVICE WAS SUCCESSFULLY DELIVERED, IT WAS NOTICED ON AN ANGIOGRAM, THAT THE INTERNAL ILIAC HAD BEEN INADVERTENTLY COVERED. THE DECISION WAS MADE BY THE PHYSICIAN TO LEAVE THE DEVICE AND MONITOR THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15375185 ↗
• InjuryJul 19, 2022Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE FROM MEDRIO CLINICAL STUDY (B)(6): ON (B)(6) 2020, THE PATIENT WAS TREATED FOR A THORACOABDOMINAL AORTIC ANEURYSM USING THREE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES, IMPLANTED IN THE RIGHT RENAL ARTERY ((B)(4)/BXA067902A), LEFT RENAL ARTERY ((B)(4)/BXA067902A) AND SUPERIOR MESENTERIC ARTERY ((B)(4)/BXA075902A). ON (B)(6) 2020, THROMBOSIS WAS OBSERVED WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ((B)(4)/BXA067902A) LOCATED IN THE RIGHT RENAL ARTERY. ON (B)(6) 2020, A BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT THE STENOSIS WITHIN THE RIGHT RENAL ARTERY STENT. ADDITIONALLY, A MEDTRONIC EVERFLEX STENT 7MM X 60MM WAS IMPLANTED TO TREAT THE OCCLUSION WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ((B)(4)/BXA067902A). ON (B)(6) 2021, STENOSIS WAS OBSERVED WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ((B)(4)/BXA075902A) LOCATED IN THE DISTAL SUPERIOR MESENTERIC ARTERY STENT. IT WAS ALSO NOTED THERE WAS STENOSIS WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ((B)(4)/BXA067902A) LOCATED IN THE DISTAL LEFT RENAL ARTERY STENT. ON THE SAME DAY, AN ANGIOPLASTY PROC

  Patient problems: Obstruction/Occlusion

  MAUDE report 15058683 ↗
• InjuryJun 23, 2022Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: SUBJECT: (B)(4), ONSET DATE: (B)(6) 2021, DESCRIPTION: RIGHT RENAL INFARCTION AFTER THROMBUS IN THE RIGHT RENAL ARTERY, OUTCOME: ONGOING - NO TREATMENT REQUIRED. 2203-A:-OTHER USED FOR RENAL INFARCTION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14791506 ↗
• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM MEDRIO DATABASE FOR AAA 17-01 STUDY. SUBJECT: (B)(4). AE #1 ONSET DATE: (B)(6) 2020. DESCRIPTION: R RENAL ARTERY DISSECTION & PERFORATION.

  Patient problems: Vascular Dissection

  MAUDE report 14750897 ↗
• MalfunctionMar 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO GORE THAT THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS CAME DETACHED FROM THE BALLOON WITHIN THE PATIENT. REPORTEDLY THE DEVICE WAS ABLE TO BE SNARED BY THE PHYSICIAN AND REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER VBX DEVICE.

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

  MAUDE report 13635212 ↗
• InjuryJan 10, 2022Migration; Migration

  ON (B)(6) 2021 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESES (TAMBE) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX) IN THE (B)(6)STUDY. ON (B)(6) 2021 THE PATIENT WAS DISCHARGED. ON (B)(6) 2021 ONE MONTH POST-OP CTA IMAGING REVEALED A TYPE III ENDOLEAK BETWEEN THE TAMBE DEVICE AND THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IN THE PATIENT'S LEFT RENAL ARTERY. IT WAS REPORTEDLY SUSPECTED THAT THE TYPE III ENDOLEAK WAS RELATED TO INADEQUATE OVERLAP OF THE DEVICES INTO THE PATIENT'S LEFT RENAL ARTERY. IT WAS REPORTED THAT THE DEVICE OVERLAP WAS TOO SHORT. ON (B)(6) 2021 A LEFT BRACHIAL CUTDOWN, SECOND ORDER CANNULATION OF THE PATIENT'S LEFT RENAL ARTERY, AND A SELECTIVE LEFT RENAL ANGIOGRAM WERE PERFORMED. THE PHYSICIAN PERFORMED LEFT RENAL ARTERY ANGIOPLASTY, AND AN ADDITIONAL VBX DEVICE WAS PLACED. IT WAS THE OPINION OF THE PHYSICIAN THAT THE PATIENT WOULD BENEFIT FROM AN EXTENSION OF THE LEFT RENAL STENT FOR BRANCH STABILITY AT A LATER DATE. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13211327 ↗
• MalfunctionDec 2, 2021Difficult or Delayed Positioning; Premature Separation; Difficult or Delayed Positioning; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021 A PATIENT PRESENTED WITH SUBTOTAL HIGHLY CALCIFIED STENOSIS IN THE RIGHT COMMON ILIAC ARTERY AND UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE. IT WAS REPORTED THAT THE PHYSICIAN ADVANCED THE VBX DEVICE ACROSS THE STENOTIC LESION, THEN PULLED THE VBX DEVICE BACK IN PLACE AT THE ILIAC BIFURCATION. THE PHYSICIAN REPORTED THAT THE FIT IN THE COMMON ILIAC ARTERY FELT VERY TIGHT, AND AFTER PULLING THE DEVICE BACK IN PLACE TO TAKE AN IMAGE BEFORE INITIATING DEPLOYMENT, IT WAS NOTICED THAT THE VBX DEVICE HAD DISLODGED FROM THE BALLOON DELIVERY CATHETER. THE DISLODGED STENT WAS PARTIALLY COVERING THE INTERNAL ILIAC ARTERY, SO THE PHYSICIAN USED THE SHEATH AND DELIVERY SYSTEM TO PUSH THE VBX STENT BACK UP INTO THE COMMON ILIAC ARTERY. THE PHYSICIAN WAS THEN ABLE TO ADVANCE THE BALLOON DELIVERY CATHETER BACK UP INSIDE THE VBX DEVICE AND COMPLETED DEPLOYMENT. THIS METHOD SHORTENED THE LENGTH OF THE VBX DEVICE, SO ANOTHER 7MM X 59MM VBX WAS PLACED PROXIMAL TO THE INITIAL VBX DEVICE IN ORDER TO COMPLETELY COVER THE LESION. THE PATIENT TOLERATED THE PROCEDURE AND THE STENOSIS WAS SUCCESSFULLY C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916004 ↗
• InjuryNov 12, 2021Material Puncture/Hole; Material Puncture/Hole

  THE FOLLOWING WAS REPORTED TO GORE: A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE WAS INTENDED FOR USE IN THE HEPATIC ARTERY. ON AN UNKNOWN EXACT DATE IN (B)(6) 2019, A VBX DEVICE WAS PLACED IN THE HEPATIC ARTERY TO TREAT AN ANEURYSM. ON (B)(6) 2020. THE PATIENT PRESENTED TO CLINIC FOR ROUTINE FOLLOW UP WHICH REVEALED ANEURYSM SAC IS THROMBOSED INDICATION: COMMON HEPATIC ARTERY STENT GRAFT FRACTURE/ENDOLEAK. ON (B)(6) 2021, THE PATIENT PRESENTED TO CLINIC FOR ROUTINE FOLLOW UP WHICH REVEALED A SMALL ENDOLEAK AND POSSIBLE STENT FRACTURE AS COMPARED TO HIS PRIOR COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA). DENIES ABDOMINAL/BACK PAIN. ANEURYSM SAC NOT DISCRETELY VISIBLE, ENDOLEAK GREATER THAN PRIOR STUDY IN 2019 AND MINIMALLY LARGER THAN 2020. THERE IS NO REPORT FROM THE PATIENT OF ANY TRAUMA TO THE ABDOMEN. THE PATIENT HAS A SCHEDULED REVISION TO RELINE THE VBX DEVICE WITH AN ADDITIONAL VBX DEVICE ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW UP AND HAD AN ARTERIOGRAM PERFORMED. AFTER THE ARTERIOGRAM WAS PERFORMED, IT CONFIRMED THAT THERE WAS NOT A STENT FRACTURE. HOWEVER, IT DID CONFIRM A SMALL ENDO LEAK. THE PHYSICIAN SUCCESSFULLY

  Patient problems: Aneurysm; Thrombosis/Thrombus

  MAUDE report 12805188 ↗
• InjuryFeb 19, 2021Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2020 A PATIENT UNDERWENT AORTIC ANEURYSM TREATMENT WITHIN THE TAMBE 1701 CLINICAL STUDY. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE UTILIZED IN THE SUPERIOR MESENTERIC ARTERY (SMA). ON (B)(6) 2020, THE MESENTERIC ARTERY CIRCULATION WAS EVALUATED WITH PULSE WAVE DOPPLER AND COLOR FLOW DUPLEX IMAGING. THE SMA WAS FOUND TO BE PATENT WITH NORMAL FLOW VELOCITIES AND DOPPLER PROFILE. ON (B)(6) 2021 SMA STENOSIS WAS REPORTED. THIS WAS DESCRIBED AS HEMODYNAMICALLY SIGNIFICANT (>70%). THIS WAS TREATED BY MEANS OF ANGIOPLASTY. ON (B)(6) 2021 THE MESENTERIC ARTERY CIRCULATION WAS EVALUATED WITH PULSE WAVE DOPPLER AND COLOR FLOW DUPLEX IMAGING. THIS SHOWED A PATENT SMA WITH NORMAL FLOW VELOCITIES AND DOPPLER PROFILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11355581 ↗
• MalfunctionSep 15, 2020Collapse; Stretched; Collapse; Stretched

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, A PATIENT UNDERWENT TREATMENT OF A TYPE IV THORACO-ABDOMINAL AORTIC ANEURYSM WITH AN INVESTIGATIONAL GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS. ADDITIONALLY, GORE® EXCLUDER® AAA AND IBE ENDOPROSTHESES WERE UTILIZED. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE UTILIZED IN THE BRANCH VESSELS. ON (B)(6) 2020, FOLLOW-UP IMAGING REVEALED AN EXTRINSIC COMPRESSION OF THE CONTRALATERAL LEG COMPONENT FROM THE IPSILATERAL LEG AND IPSILATERAL ILIAC EXTENDER COMPONENTS WITHIN THE AORTA JUST PROXIMAL OF THE AORTIC BIFURCATION. ALSO NOTED WAS A DEVICE OVALIZATION OF THE LEFT RENAL ARTERY SIDE BRANCH COMPONENT AT THE ORIGIN OF THE LEFT RENAL ARTERY. THIS IS BELIEVED TO BE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. NO INTERVENTIONS HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10538792 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A THORACOABDOMINAL AORTIC ANEURYSM (TAAA) CLASS IV THAT WAS SUCCESSFULLY TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND SEVEN GORE VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES THAT WERE USED AS SIDE BRANCH COMPONENTS ON (B)(6) 2019. IT WAS STATED THAT TWO VBX DEVICES WERE IMPLANTED IN THE LEFT RENAL ARTERY. ON (B)(6) 2020, AN OCCLUSION OF THE LEFT RENAL ARTERY WAS IDENTIFIED AND SUCCESSFULLY TREATED WITH LYTIC THERAPY ON (B)(6) 2020. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombosis

  MAUDE report 10410668 ↗
• InjuryMar 23, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2020, THE PATIENT WAS BEING TREATED AN UNKNOWN ETIOLOGY USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX). ON (B)(6) 2020, THE PATIENT PRESENTED TO THE HOSPITAL FOR FOLLOW-UP. IT WAS REPORTED A POSSIBLE INFECTION OF THE VBX WAS IDENTIFIED. IT IS UNKNOWN IF THE INFECTION IS ATTRIBUTABLE TO A PRE-EXISTING INFECTION IN FIELD OF TREATMENT. AN ADDITIONAL ZILVER STENT WAS IMPLANTED EXTENDING FROM THE VBX. THE PHYSICIAN IS GOING TO MONITOR THE PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 9866348 ↗
• InjuryNov 14, 2019Collapse; Collapse

  IT WAS REPORTED THAT ON (B)(6) 2019, 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. A PRE-CT, DATED (B)(6) 2019, SHOWED THAT THE CELIAC ARTERY WAS SOMEWHAT STENOTIC (DIAMETER OSTIUM 5.5 MM, DIAMETER 15 MM DISTAL 7.5 MM). INTRAOPERATIVELY, THE SUPERIOR MESENTERIC ARTERY (SMA) BRANCH WAS DEPLOYED PRIOR TO THE CELIAC BRANCH. WHEN INTRODUCING THE SHEATH AND CELIAC BRANCH COMPONENT, INITIAL RESISTANCE WAS FELT WHICH WAS BELIEVED TO BE DUE TO STENOSIS AT THE CELIAC OSTIUM. HOWEVER, CELIAC BRANCH COMPONENTS WERE SUCCESSFULLY DELIVERED AND DEPLOYED. ON (B)(6) 2019, IT WAS IDENTIFIED THAT THE SMA BRANCH WAS PARTIALLY COMPRESSED / STENOTIC BETWEEN THE OUTLET OF ITS PORTAL ON THE TAMBE AORTIC COMPONENT AND THE OSTIUM OF THE SMA. THE CAUSALITY CANNOT BE CONFIRMED, BUT IT IS SUSPECTED THAT THIS STENOSIS MAY HAVE OCCURRED WHEN INTRODUCING AND DEPLOYING THE CELIAC BRANCH COMPONENTS. INTRAVASCULAR ULTRASOUND (IVUS) WAS UTILIZED TO DETERMINE THE MORPHOLOGY OF THE SMA STENT

  Patient problems: Occlusion

  MAUDE report 9321286 ↗

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