GORE VIABAHN VBX Balloon Expandable Endo BXA115902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00733132637744), received between Jul 10, 2018 and Jun 16, 2026 — classified as 6 deaths, 7 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, DURING A PHYSICIAN-MODIFIED ENDOGRAFT (PMEG) PROCEDURE, AN 8FR COOK SHEATH WAS USED TO ADVANCE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). THE VBX DEVICE WAS INTENDED TO BE ADVANCED INTO A 12MM PORTAL OF A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE). AS REPORTED, THE VBX DEVICE ADVANCED SMOOTHLY UNTIL IT REACHED THE TARGET TREATMENT LOCATION (UNSPECIFIED). THE VBX DEVICE WAS NOT ABLE TO PASS THROUGH THE TBE DEVICE PORTAL. THE VBX DEVICE WAS REMOVED THROUGH THE SHEATH WITH NO ISSUES, THEN THE PORTAL WAS BALLOONED. THE SAME VBX DEVICE WAS ADVANCED AGAIN. AT THIS TIME, IT WAS REALIZED THE VBX STENT WAS MISSING AND HAD DISLODGED. FLUOROSCOPY WAS USED IN ATTEMPTS TO LOCATE THE DISLODGED VBX STENT. THE BACK TABLE WAS ALSO CHECKED, BUT THE VBX STENT WAS NOT LOCATED. A NEW VBX DEVICE WAS IMPLANTED WITHOUT DIFFICULTIES. IT WAS REPORTED THE TECHNICIANS WERE UNSURE IF THE FIRST VBX STENT WAS ON THE BALLOON CATHETER DURING PREPPING OR REMOVAL OF THE VBX DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. IT WAS REPORTED FURTHER SEARCH IS PLANNED FOR THE MISSING VBX STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25526494 ↗
• InjuryMay 7, 2026Complete Blockage

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR TAMBE PROCEDURE UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC), GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WERE USED. REPORTEDLY, A CTAGAC WAS FIRST PLACED PROXIMAL TO THE CELIAC ARTERY TO ACHIEVE SEAL PRIOR TO DEPLOYMENT OF THE TAMBE DEVICE. FOLLOWING PLACEMENT OF THE TAMBE, AN INITIAL ANGIOGRAM DEMONSTRATED THAT THE CTAGAC APPEARED TO BE POSITIONED AT THE ORIGIN OF THE CELIAC ARTERY, WITH CONCERN FOR PARTIAL OCCLUSION. AS THE CELIAC PORTAL WAS ON THE SUPERIOR MESENTERIC ARTERY (SMA), A VBX WAS THEN PUT IN FROM THE CTAGAC AND COULD NO LONGER VISUALIZE THE CELIAC ARTERY. THE CELIAC ARTERY BECAME FULLY OCCLUDED WITH NO BLOOD FLOW. NO ADDITIONAL CLINICAL ISSUES RELATED TO THE OCCLUSION WERE REPORTED, AND THERE WERE NO PLANS TO REINTERVENE ON THE OCCLUDED CELIAC ARTERY. THE PHYSICIAN ATTRIBUTED THE CELIAC ARTERY OCCLUSION TO A COMBINATION OF THE CTAGAC AND VBX DEVICES.

  Patient problems: Stenosis

  MAUDE report 25117785 ↗
• MalfunctionSep 3, 2025Premature Separation; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, AN 11MM X 59MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE LEFT COMMON ILIAC ARTERY DURING A REVISION OF ENDOLOGIX AAA LIMB (NON-GORE DEVICE) WITH DISTAL STENOSIS. PHYSICIAN WAS TREATING A THROMBOSED ENDO AAA GRAFT WITH AN OCCLUSION AT THE DISTAL END OF THE LEFT COMMON ILIAC LIMB OF THE ENDO AAA DEVICE. PHYSICIAN PRE-DILATED THE DISTAL END OF THE ENDO GRAFT. PHYSICIAN ATTEMPTED TO DELIVER THE VBX DEVICE, BUT IT WOULD NOT PASS INTO THE LIMB OF THE ENDO GRAFT. PHYSICIAN WITHDREW THE VBX DEVICE THROUGH THE 11FR INTRODUCER SHEATH WITH INTENT TO BALLOON THE VESSEL MORE TO ALLOW FOR PASSAGE. AFTER REMOVAL, PHYSICIAN NOTICED THAT THE VBX DEVICE WAS NO LONGER ON THE DELIVERY CATHETER BALLOON. IT WAS CONFIRMED BY XRAY SHOWING THE VBX DEVICE WAS IN THE LEFT COMMON ILIAC ABOUT 2CM BELOW WERE HE COULDN'T PASS PREVIOUSLY. PHYSICIAN USED AN 8MM MUSTANG BALLOON TO CAPTURE THE VBX DEVICE AND DEPLOY TO 8MM IN THE LEFT COMMON ILIAC. THE PHYSICIAN THEN PRE-DILATED THE LESION AREA THAT WOULD NOT CROSS PREVIOUSLY. THEN THE PHYSICIAN BRIDGED THE ENDO AAA GRAFT LIMB AND THE VBC DEVICE WITH A 10MM X 39MM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956611 ↗
• MalfunctionAug 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT PRESENTED WITH A BILATERAL ILIAC ARTERY OCCLUSION. IT WAS REPORTED THE PATIENT HAD A TORTUOUS ANATOMY AND THE VESSEL HAD CALCIUM WITH CHRONIC TOTAL OCCLUSION. BOTH ILIAC ARTERIES WERE TREATED WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). AS REPORTED, AN 8 X 39 VBX DEVICE WAS IMPLANTED IN THE LEFT ILIAC ARTERY WITH NO ISSUES. THE OCCLUSION ON THE RIGHT SIDE REQUIRED BALLOONING TO ALLOW FOR DEVICE ADVANCEMENT. AN 8FR TERUMO 10CM SHEATH WAS USED TO ADVANCE AN 11 X 59 VBX DEVICE OVER AN .035 AMPLATZ GUIDEWIRE. AS THE PHYSICIAN ATTEMPTED TO CROSS THE RIGHT-SIDE LESION, THE VBX STENT APPEARED TO CATCH ON A CALCIUM AND THE VBX STENT WAS DISLODGED FROM THE VBX DELIVERY CATHETER. THE AFFECTED VBX DEVICE WAS GENTLY REMOVED THROUGH THE SHEATH ALONG WITH THE CATHETER. A NEW 8 X 59 VBX DEVICE WAS ADVANCED, DEPLOYED AND BALLOONED TO THE REQUIRED SIZE. THE PATIENT TOLERATED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716700 ↗
• InjuryJun 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM AND A LEFT COMMON ILIAC ANEURYSM USING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) SYSTEM WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IN THE LEFT INTERNAL ILIAC ARTERY. AT THE CONCLUSION OF THE CASE, THE PHYSICIAN NOTED A POSSIBLE ENDOLEAK BUT DECIDED TO WAIT AND SEE IF IT WOULD RESOLVE. ON AN UNKNOWN DATE, THE FOLLOW-UP CT CONFIRMED MULTIPLE ENDOLEAKS, AT THE DISTAL SEAL ZONES OF BOTH THE IBE DEVICE AND THE GORE® VIABAHN® VBX DEVICE. ON (B)(6) 2025, A REINTERVENTION TOOK PLACE. ADDITIONAL STENT GRAFTS WERE PLACED EXTENDING BOTH THE IBE DEVICE AND THE GORE® VIABAHN® VBX DEVICE. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE GORE® VIABAHN® VBX DEVICE WAS LANDED SHORT OF THE TARGET LOCATION, AND THE VESSEL AT THE DISTAL SEAL ZONE WAS TOO WIDE FOR THE IBE DEVICE.

  Patient problems: Clinical Endoleak

  MAUDE report 22340609 ↗
• InjuryMay 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE ILIAC ARTERY DURING TREATMENT OF AN ANEURYSM. AFTER THE DEVICE WAS ADVANCE INTO POSITION THE PATIENT MOVED. THE PHYSICIAN WANTED TO REMOVE THE VBX DEVICE BEFORE HE RAN ANOTHER ANGIOGRAM WITH CONTRAST. DURING THE REMOVAL OF THE VBX DEVICE THROUGH AN 8FR X 10CM TERUMO INTRODUCER SHEATH, THE VBX DEVICE DISLODGED FROM THE DELIVERY CATHETER. THE PATIENT WAS MOVED TO THE OR AND A CUT DOWN WAS PERFORMED IN ORDER TO REMOVE THE UNDEPLOYED VBX DEVICE. THE PHYSICIAN THEN COMPLETED THE PROCEDURE WITH A NEW VBX DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097798 ↗
• MalfunctionMay 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, A PATIENT UNDERWENT A THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE TO TREAT AN ANEURYSM. DURING THIS PROCEDURE, A 11MM X 59MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) AND A 9MM X 79MM VBX DEVICE WERE USED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. IT WAS REPORTED DURING THE PROCEDURE, WHILE ADVANCING THE 11MM X 59MM VBX DEVICE OVER AN UNKNOWN BRAND GUIDEWIRE THROUGH A TOURGUIDE INTRODUCER SHEATH (SIZE UNKNOWN), RESISTANCE WAS ENCOUNTERED AS THE PHYSICIAN ATTEMPTED TO REACH THE TARGET TREATMENT SITE (CELIAC ARTERY). THIS RESISTANCE WAS CAUSED BY STENOSIS IN THE CELIAC ARTERY. AS THE PHYSICIAN TRIED TO REMOVE THE VBX DEVICE, IT BECAME CAUGHT AROUND A BEND DUE TO PATIENT'S VERY TORTUOUS ANATOMY. IN ADDITION, THE VBX DEVICE ALSO GOT STUCK ON ONE OF THE WIRES ON THE TAMBE PORT. A SNARE WAS USED TO REMOVE THE VBX DEVICE AFTER THE STENT BECAME DISLODGED FROM THE CATHETER. A REPLACEMENT VBX DEVICE WAS USED SUCCESSFULLY. IT IS UNKNOWN IF THE VESSEL WAS PREDILATED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057873 ↗
• DeathMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PROCEDURE WAS INITIALLY PLANNED FOR A COVERED ENDOVASCULAR RECONSTRUCTION OF AORTIC BIFURCATION (CERAB) TO ADDRESS HEAVILY CALCIFIED AORTA AND COMMON ILIAC ARTERIES. THE PROCEDURE BEGAN WITH A RIGHT FEMORAL ENDARTERECTOMY, FOLLOWED BY WIRE ACCESS BEING ACHIEVED BILATERALLY. AN 11MM X 59MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE S/N (B)(6) WAS ADVANCED TO THE DISTAL AORTA, AND THE BALLOON WAS INFLATED TO RATED BURST PRESSURE. THE VBX DEVICE DELIVERY SYSTEM CATHETER WAS WITHDRAWN SUCCESSFULLY. SUBSEQUENTLY, A 16MM ARMADA BALLOON WAS ADVANCED INTO THE 11MM X 59MM VBX DEVICE AND INFLATED FOR POST DILATION TO 16MM. AT APPROXIMATELY NOMINAL PRESSURE THE ARMADA BALLOON RUPTURED. AT THIS TIME, A FLUSH CATHETER WAS INTRODUCED TO TAKE IMAGES AND REVEALED AN AORTIC RUPTURE AT THE MID-LEVEL OF THE VBX DEVICE. TO MANAGE THE LEAKAGE AND RUPTURE, PHYSICIAN DECIDED TO USE A 20MM GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC CUFF) TO COVER THE AREA OF LEAKAGE AND RUPTURE. THE PHYSICIAN THEN ATTEMPTED TO INTRODUCE THE CUFF THROUGH A GORE® 15FR DRYSEAL FLEX INTRODUCER SHEATH ON THE RIGHT, BUT ADVANCEMENT WAS HINDERED DUE TO CALCIFIED ILIAC. IN THE PROCESS OF CRE

  Patient problems: Calcium Deposits/Calcification; Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 21691701 ↗
• DeathOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR AORTOILIAC OCCLUSION WHERE SIX GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE USED. IT WAS REPORTED THE VBX DEVICES WERE IMPLANTED IN THE AORTIC BIFURCATION AND RIGHT ILIAC ARTERY. DURING THE PROCEDURE THE RIGHT ILIAC ARTERY RUPTURED. THE PATIENT REQUIRED 4 UNITS OF PACKED RED BLOOD CELLS (PRBCS) INTRAVENOUSLY DUE TO BLOOD LOSS. IT IS SUSPECTED THE PLAQUE BEING PUSHED UP AGAINST THE AORTOILIAC BIFURCATION COULD HAVE CAUSED THE RUPTURE. IT IS UNKNOWN WHICH VBX DEVICE WAS IMPLANTED IN THE RIGHT ILIAC ARTERY. REPORTEDLY, ADDITIONAL VBX DEVICES WERE IMPLANTED TO CONTROL THE RUPTURE AND BLEEDING. REPORTEDLY, THE PATIENT WAS VERY ILL AND WAS NOT A SURGICAL CANDIDATE DUE TO THEIR CONDITION AT THE TIME OF THE EVENT. IT WAS REPORTED THERE WAS CONCERN ABOUT RUPTURE RISK PRIOR TO STENT PLACEMENT DUE TO THE HEAVILY CALCIFIED VESSELS. THE PATIENT EXPIRED A FEW DAYS AFTER THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 20539077 ↗
• InjuryOct 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024, A PATIENT UNDERWENT A PROCEDURE IN THE RIGHT EXTERNAL ILIAC ARTERY TO TREAT AN UNKNOWN ETIOLOGY USING AN 11 MM X 59 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT CONTRALATERALLY VIA THE LEFT COMMON FEMORAL ARTERY USING AN 8F UNKNOWN BRAND INTRODUCER SHEATH OVER AN UNKNOWN SIZE LUNDERQUIST GUIDEWIRE. REPORTEDLY, THE ANATOMY WAS VERY TORTUOUS AND IT WAS DIFFICULT TO ADVANCE THE SHEATH OVER THE BIFURCATION AND INTO POSITION. AN ATTEMPT WAS MADE TO ADVANCE THE DELIVERY CATHETER. DUE TO THE TORTUOSITY, THE DELIVERY CATHETER DID NOT MAKE IT TO THE TARGET TREATMENT ZONE. THE DELIVERY CATHETER WAS WITHDRAWN BACK THROUGH THE SHEATH, AND THE ENDOPROSTHESIS BECAME DISLODGED. A CUT DOWN WAS PERFORMED TO REMOVE THE DISLODGED ENDOPROSTHESIS. ANOTHER 11 MM X 59 MM VBX DEVICE WAS ADVANCED FROM THE RIGHT SIDE AND IMPLANTED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384784 ↗
• InjuryMay 16, 2024No Apparent Adverse Event; Migration; No Apparent Adverse Event; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT WAS IMPLANTED WITH TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES TO TREAT A LEFT COMMON ILIAC ANEURYSM. ONE VBX DEVICE ( (B)(6) ) WAS PLACED PROXIMAL LEFT COMMON ILIAC AND THE OTHER ( (B)(6) ) WAS PLACED DISTAL LEFT COMMON ILIAC TO LEFT EXTERNAL ILIAC. REPORTEDLY, THE PHYSICIAN INTENTIONALLY COVERED THE LEFT INTERNAL ILIAC ARTERY AS IT WAS ALREADY OCCLUDED. ON AN UNKNOWN DATE, THE PHYSICIAN NOTICED AN TYPE IIIC ENDOLEAK BETWEEN THE TWO VBX DEVICES AS THERE WAS APPROXIMATELY 5MM OF SEPARATION BETWEEN THE 2 VBX DEVICES. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO ADDRESS THE ENDOLEAK. THE ENDOLEAK WAS RESOLVED AT THE CONCLUSION OF THE PROCEDURE AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 19336860 ↗
• MalfunctionMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024, A PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE WHERE AN ENDOLOGIX AFX®2 ENDOVASCULAR AAA SYSTEM WAS USED AS THE MAIN AORTIC STENT GRAFT AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT GRAFT) WAS USED IN THE LEFT INTERNAL ILIAC ARTERY (IIA) TO EXTEND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). IT WAS REPORTED THE PHYSICIAN WAS ATTEMPTING TO ADVANCE THE DELIVERY SYSTEM CATHETER CONTRALATERALLY UP AND OVER USING A 8F SHEATH INSIDE A 16F GORE® DRYSEAL FLEX INTRODUCER SHEATH. REPORTEDLY, THE DELIVERY CATHETER HAD TO GO WAY UP INTO THE MID AORTA JUST PROXIMAL TO THE AORTIC DEVICE FLOW DIVIDER CREATING A 180 DEGREE BEND. THE VBX DEVICE DELIVERY CATHETER WAS BEING USED AS A CANNULATION CATHETER TO ADVANCE .035" ADVANTAGE THE GUIDE WIRE INTO THE IBE GATE AND INTO THE HYPOGASTRIC. JUST PROXIMAL TO THE IBE GATE AND THE IBE DEVICE, THE SHEATH FLIPPED UP INTO THE AORTA AND THE STENT GRAFT DISLODGED FROM THE BALLOON. FLUOROSCOPY SHOWED THE STENT GRAFT IN THE PROXIMAL DESCENDING AORTA. THE DEVICE WAS SUCCESSFULLY RETRIEVED USING A MERIT EN SNARE SYSTEM. TO COMPLETE THE PROCEDURE AN 8L X 59 MM AND AND 8L X 79 MM VBX STENT GRAFT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299788 ↗
• MalfunctionApr 8, 2024Premature Activation; Malposition of Device; Device Dislodged or Dislocated; Premature Activation; Malposition of Device; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT TREATMENT FOR VENOUS THROMBOSIS IN THE COMMON ILIAC USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). IT WAS REPORTED THAT THE PHYSICIAN WAS NOT ABLE TO REACH THE COMMON ILIAC DUE A FIBROTIC CLOT. THE PHYSICIAN WAS ABLE TO GO UP A TERUMO 11FR PINNACLE SHEATH AND OVER A TERUMO GUIDEWIRE ADVANTAGE .035". WHILE TRYING TO ADVANCE THE VBX DEVICE ACROSS THE LESION, THE PROXIMAL EDGE OF THE STENT PARTIALLY DEPLOYED. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE VBX DEVICE THROUGH THE SHEATH AND NOTICED THE VBX DEVICE PULLED OFF THE BALLOON. IT WAS DECIDED TO FULLY DEPLOYED AND EXPANDED WHERE THE VBX DEVICE CAME OFF THE BALLOON IN THE EXTERNAL ILIAC VEIN. THE PROCEDURE WAS COMPLETED BY PLACING AN ADDITIONAL DEVICE IN ORDER TO TREAT THE DESIRED AREA, THE COMMON ILIAC VEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067076 ↗
• DeathDec 11, 2023Partial Blockage; Partial Blockage

  ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC DISSECTION AND PENETRATING AORTIC ARCH ULCER AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE). AN OPEN SURGICAL PROCEDURE WAS NOT AN OPTION DUE TO PATIENT CONDITION AND ACCESS WAS OBTAINED IN THE ABDOMINAL AORTA. THE PATIENT HAD PREVIOUSLY RECEIVED A PROCEDURE TO BYPASS THE LSA TO THE LCCA AND BCA. THE PATIENT HAD AN EXISTING CABG COMING OFF THE MID-BCA AND A LIMA BYPASS OFF THE LSA. PRIOR TO PLACEMENT OF TBE, THE PATIENT WAS HYPOTENSIVE WITH INCREASED PRESSURE IN THE LEFT ARM COMPARED TO THE RIGHT. THE TBE WAS PLACED WITH THE SIDE BRANCH IN THE LSA AND WITH INTENTIONAL PARTIAL COVERAGE OF THE BCA PROXIMALLY WITH THE AORTIC COMPONENT (AC). IT WAS REPORTED THAT THE PORTAL OPENING ON THE GORE® TAG® AORTIC COMPONENT (TAC123715A/25765796) HAD LANDED SLIGHTLY DISTAL TO THE LSA, LEAVING PLACEMENT OF THE SIDE BRANCH (TSB121506A/26679693) A LITTLE COMPRESSED. POST OPERATIVE CTA DEMONSTRATED A MODERATE STENOSIS IN THE COMPRESSED PORTION OF THE SIDE BRANCH. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGMR373710/23079450) WAS PLACED PROXIMALLY TO THE TAC TO E

  Patient problems: Restenosis

  MAUDE report 18304092 ↗
• MalfunctionOct 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6), 2023, THE PATIENT UNDERWENT TREATMENT FOR A TYPE 1B ENDOLEAK IN AN EXISTING MEDTRONIC ENDURANT STENT GRAFT USING A 11 MM X 59 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) IN THE INTERNAL COMPONENT. IT WAS REPORTED THE PHYSICIAN WAS PERFORMING A UNILATERAL DEPLOYMENT TECHNIQUE WHERE A 10F GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS PLACED IN THE ILIAC BRANCH ENDOPROSTHESIS (IBE) GATE. REPORTEDLY, DURING ADVANCEMENT, THE VBX DEVICE DELIVERY SYSTEM TRACKED THROUGH THE SHEATH WITHOUT ISSUE UNTIL IT MET RESISTANCE IN THE DISTAL PORTION OF THE SHEATH NEAR THE FLOW DIVIDER. DESPITE APPLYING FORCE, IT WOULD NOT ADVANCE FURTHER. AN ATTEMPT WAS MADE TO RETRACT THE DELIVERY SYSTEM CATHETER BACK THROUGH THE SHEATH BUT THERE WAS TOO MUCH RESISTANCE. THE DECISION WAS THEN MADE TO UNSHEATHE THE STENT-GRAFT. WHEN THEY TRIED TO RETRACT EVERYTHING, THE VBX DEVICE STENT-GRAFT DISLODGED FROM THE BALLOON, AND WAS FREE FLOATING IN THE IBE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED BY REMOVING THE 10F SHEATH, AND ALSO LOSING WIRE. A NEW WIRE AND A 16F SHEATH WERE ADVANCED DEEPER IN THE IBE GATE. ANOTHER VBX DEVICE WAS ADVANCED OVER THE FLOW DIVIDER AND DEPLOYED IN THE

  Patient problems: Foreign Body In Patient

  MAUDE report 17852692 ↗
• DeathJun 12, 2023Adverse 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) 2023 BILATERAL GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES) WERE IMPLANTED IN THE LEFT AND RIGHT COMMON ILIAC ARTERIES TO TREAT AN AORTOILIAC ANEURYSM. THE PHYSICIAN INITIATED THE PROCEDURE WITH ENDOVASCULAR LITHOTRIPSY BILATERALLY IN THE RIGHT AND LEFT COMMON ILIAC ARTERIES WITH A SHOCKWAVE DEVICE. THE VBX DEVICES WERE IMPLANTED WITHOUT DIFFICULTY OR COMPLICATIONS. AFTER POST DILATION A FINAL CTA WAS RUN THAT INDICATED A BLEED IN THE AORTA. AT THAT TIME A GORE® EXCLUDER®AAA ENDOPROSTHESIS WAS IMPLANTED FOR A ZONE 9 INFRARENAL DISSECTION. IT IS UNKNOWN WHAT EVENTS LED TO AN OPEN PROCEDURE AFTER THE GORE® EXCLUDER®AAA ENDOPROSTHESIS WAS IMPLANTED. THE PATIENT EXPIRED ON (B)(6) 2023 AT 8:50PM. MORE INFORMATION IS BEING OBTAINED INCLUDING IF THE PATIENT'S CAUSE DEATH WAS GORE DEVICE RELATED.

  Patient problems: Vascular Dissection

  MAUDE report 17112961 ↗
• MalfunctionMar 28, 2023Premature Separation; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, A PATIENT PRESENTED WITH IN-STENT RE-STENOSIS OF MEDTRONIC VISI-PRO STENTS IN AN EXTERNAL ILIAC ARTERY AND UNDERWENT TREATMENT UTILIZING FOUR GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX) DEVICES. THE PHYSICIAN GAINED FEMORAL ACCESS AND ADVANCED A VBX DEVICE THROUGH AN 8FR X 23 CORDIS BRITE TIP¿ SHEATH. THE DEVICE WAS UNABLE TO BE ADVANCED TO THE INTENDED LOCATION, SO THE PHYSICIAN DECIDED TO WITHDRAW THE DEVICE. DURING WITHDRAWAL, THE VBX DEVICE BECAME CAUGHT ON A PREVIOUSLY IMPLANTED STENT AND DISLODGED FROM THE DELIVERY CATHETER. THE VBX BALLOON DELIVERY CATHETER WAS REMOVED FROM THE PATIENT, AND A 4 X 60 MEDTRONIC EVERCROSS PTA BALLOON WAS ADVANCED INTO THE UNDEPLOYED VBX DEVICE. AFTER THE VBX DEVICE WAS INITIALLY EXPANDED, THE PHYSICIAN UPSIZED TO A 7X60 MEDTRONIC EVERCROSS PTA BALLOON AND OPTIMALLY DEPLOYED THE VBX DEVICE WITHIN THE EXTERNAL ILIAC ARTERY. THE DISLODGED VBX DEVICE WAS DEPLOYED WITHIN AN INTENDED AREA OF TREATMENT, PRESERVING THE HYPOGASTRIC ARTERY. THREE ADDITIONAL VBX DEVICES WERE USED TO COMPLETE THE PROCEDURE WITH NO INCIDENCE. THE PATIENT TOLERATED THE PROCEDURE WITH NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632036 ↗
• MalfunctionJan 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, A PATIENT WAS TREATED FOR STENOSIS OF THE BRACHIOCEPHALIC VEIN / SUPERIOR VENA CAVA (SVC) THAT MEASURED APPROXIMATELY 5-6MM BY UTILIZING AN IVUS AS REPORTED, SEVERAL OPTIONS WERE CONSIDERED, BUT DUE TO THE RISK OF RUPTURE, THE PHYSICIAN ELECTED TO IMPLANT A COVERED STENT. AFTER CTA ANALYSIS AND SUBSEQUENT VENOGRAMS, AN 11 X 59 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS SELECTED. FROM THE RIGHT FEMORAL VEIN ACCESS, THE VBX DEVICE WAS PLACED VIA 8FR PINNACLE SHEATH INTO THE RIGHT BRACHIOCEPHALIC VEIN /PROXIMAL SVC JUNCTION. PLACEMENT WAS CONFIRMED AND VBX BALLOON WAS INFLATED TO NOMINAL PRESSURE AND THEN TO RBP OF 12ATM UNDER FLUOROSCOPY. BALLOON DEFLATION WAS FLUOROSCOPICALLY VERIFIED. VBX BALLOON WAS REMOVED OVER THE WIRE IN ORDER TO POST DILATE THE VBX STENT TO 16MM USING ANOTHER BALLOON. STENT POSITION WAS CHECKED AGAIN AND IT WAS NOTICED THE VBX STENT HAD MIGRATED ON THE WIRE INTO THE RIGHT ATRIUM OF THE HEART. THE 8FR SHEATH WAS SWITCHED FOR AN INARI 20FR SHEATH TO ALLOW FOR OTHER MODALITIES TO STABILIZE AND RETRIEVE THE MIGRATED VBX STENT. WHILE MAINTAINING THROUGH AND THROUGH WIRE ACCESS, A 15-30MM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269022 ↗
• MalfunctionDec 5, 2022Premature Separation; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT TREATMENT IN THE INTERNAL ILIAC ARTERY FOR AN UNKNOWN ETIOLOGY USING TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES. IT WAS REPORTED THE PHYSICIAN ACCESSES THE TREATMENT AREA USING AN UNKNOWN SHEATH. IN ROUTE TO THE TARGET TREATMENT AREA, THE VBX DEVICE DETACHED FROM THE CATHETER, NECESSITATING DEPLOYED IN THE COMMON FEMORAL ARTERY. A SURGICAL BALLOON WAS USED TO EXPAND AND IMPLANT THE DEVICE IN THE UNINTENDED LOCATION. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER VBX DEVICE. THIS DEVICE REACHED THE TARGET TREATMENT AREA BUT ALSO BECAME DETACHED FROM THE CATHETER. A SURGICAL BALLOON WAS USED TO IMPLANT THIS DEVICE AS WELL. THE PHYSICIANS STATED HIS SUSPECTED CAUSE OF BOTH THE DEVICES SEPARATING FROM THE DELIVERY SYSTEM CATHETERS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15920616 ↗
• MalfunctionDec 5, 2022Premature Separation; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT TREATMENT IN THE INTERNAL ILIAC ARTERY FOR AN UNKNOWN ETIOLOGY USING TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES. IT WAS REPORTED THE PHYSICIAN ACCESSES THE TREATMENT AREA USING AN UNKNOWN SHEATH. IN ROUTE TO THE TARGET TREATMENT AREA, THE VBX DEVICE DETACHED FROM THE CATHETER, NECESSITATING DEPLOYED IN THE COMMON FEMORAL ARTERY. A SURGICAL BALLOON WAS USED TO EXPAND AND IMPLANT THE DEVICE IN THE UNINTENDED LOCATION. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER VBX DEVICE. THIS DEVICE REACHED THE TARGET TREATMENT AREA BUT ALSO BECAME DETACHED FROM THE CATHETER. A SURGICAL BALLOON WAS USED TO IMPLANT THIS DEVICE AS WELL. THE PHYSICIANS STATED HIS SUSPECTED CAUSE OF BOTH THE DEVICES SEPARATING FROM THE DELIVERY SYSTEM CATHETERS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15920419 ↗
• MalfunctionNov 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2022, THE PATIENT UNDERWENT TREATMENT OF AN INTERNAL ILIAC ARTERY ANEURYSM USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS AND A GORE® DRYSEAL FLEX INTRODUCER SHEATH. IT WAS REPORTED THE ACCESS SITE WAS THE RIGHT COMMON FEMORAL ARTERY USING A 12 F DRYSEAL FLEX INTRODUCER SHEATH AND A ABBOTT TAD II GUIDE WIRE. THE 12 F DRYSEAL INTRODUCER SHEATH WAS NOTED TO BE INTRODUCED INTO A 16 F DRYSEAL INTRODUCER SHEATH FOR ADDITIONAL SUPPORT DUE TO A TIGHT TURN. THE DISTAL TIP OF VBX DEVICE MET RESISTANCE AT THE DISTAL END OF THE SHEATH BUT COULD NOT BE ADVANCED OUT OF THE SHEATH. THE PHYSICIAN ALSO MET RESISTANCE WHILE WITHDRAWING THE DEVICE BACK THROUGH THE SHEATH. EVENTUALLY, THE CATHETER WAS REMOVED AND IT WAS IDENTIFIED THE STENT GRAFT SEPARATED INSIDE THE SHEATH. ONCE THE DELIVERY SYSTEM WAS OUT OF THE PATIENT, IT WAS NOTED THERE WAS A KINK IN THE GORE® DRYSEAL SHEATH. IT WAS NOTED THERE WAS NO DAMAGE TO THE PACKAGE OR DEVICE DURING BACK TABLE PREPARATION OF THE DEVICE. IT WAS REPORTED THE PHYSICIAN SUSPECTS THE KINK IN THE SHEATH IS THE REASON FOR THE RESISTANCE DURING WITHDRAWAL REQUIRING INCREASED FORCE, AND THE SEPARATION OF THE DEVICE FROM THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15782542 ↗
• InjuryFeb 4, 2022Separation Problem; Separation Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT A PROCEDURE TO EXPANDED A COLLAPSED PREVIOUSLY IMPLANTED STENT GRAFT IN THE PATIENTS ILIAC ARTERY USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. A GLIDEWIRE .035 WIRE WAS USED DURING THE PROCEDURE. THE DEVICE WAS ADVANCED AND MET RESISTANCE DUE TO TORTUOSITY IN THE ILIAC ARTERY. THE DEVICE WAS ATTEMPTED TO BE WITHDRAWN THROUGH THE SHEATH, HOWEVER, THE DEVICE WOULD NOT WITHDRAW THROUGH THE 8FR SHEATH (BRAND UNKNOWN). THE STENT GRAFT WAS DETACHED FROM THE CATHETER IN THE COMMON ILIAC ARTERY. A CUT DOWN WAS PERFORMED TO RETRIEVE THE DEVICE. ANOTHER GORE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13455785 ↗
• DeathMar 31, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A COVERED ENDOVASCULAR RECONSTRUCTION OF THE AORTIC BIFURCATION TO TREAT AORTOILIAC OCCLUSIVE DISEASE. THREE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX) WERE IMPLANTED IN THE PATIENTS AORTOILIAC BIFURCATION. A DISSECTION WAS THEN NOTED AND WAS SUSPECTED TO BE ORIGINATING FROM THE AORTOILIAC BIFURCATION (EXACT LOCATION UNKNOWN). THE DISSECTION WAS SUSPECTED BY THE PHYSICIAN TO HAVE BEEN CAUSED BY THE BALLOONING OF THE STENTS AS THE PATIENTS ANATOMY WAS EXTREMELY FRIABLE. TWO ADDITIONAL VBX DEVICES WERE IMPLANTED, ONE PROXIMAL AND ONE DISTAL OF THE PREVIOUSLY IMPLANT VBX DEVICES FOR EXTENSION TO TREAT THE DISSECTION. THE DISSECTION WAS STILL PRESENT AND THE PATIENT CONTINUED TO EXPERIENCE BLOOD LOSS. A MEDTRONIC COVERED STENT WAS IMPLANTED TO RELINE THE PREVIOUSLY IMPLANTED DEVICES. THE DISSECTION WAS STILL PRESENT WITH NOTED BLOOD LOSS CONTINUING TO OCCUR. A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED IN THE DISTAL AORTA TO TREAT THE DISSECTION. THE PATIENT UNDERWENT A BLOOD TRANSFUSION. THE PATIENT EXPIRED DUE TO EXSANGUINATION.

  Patient problems: Exsanguination

  MAUDE report 11596061 ↗
• MalfunctionDec 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING AN ENDOVASCULAR TREATMENT FOR ANEURYSM AND OCCLUSION, AN 8FR ANSEL SHEATH WAS PLACED INSIDE A 12FR GORE® DRYSEAL FLEX INTRODUCER SHEATH THAT WAS GOING THROUGH A 16FR GORE® DRYSEAL FLEX INTRODUCER SHEATH. AS REPORTED, THE ILIAC BRANCH COMPONENT OF IBE AND EXCLUDER C3 DEVICES WERE PLACED. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS TO BE IMPLANTED IN THE INTERNAL ILIAC ARTERY. WITH A BUDDY WIRE IN PLACE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE VBX DEVICE UP AND OVER THE C3 FLOW DIVIDER. HOWEVER, THE VBX DEVICE WOULD NOT PASS. CONSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE VBX DEVICE IN ORDER TO DILATE THE TIGHT SPACE WITH A PTA BALLOON. DURING WITHDRAWAL OF THE VBX DEVICE, IT GOT CAUGHT ON 8FR SHEATH EDGE, DISLODGING THE DEVICE FROM THE CATHETER. THE VBX DEVICE WAS ABLE TO BE REMOVED WITHOUT A SNARE. A NEW VBX DEVICE WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10972456 ↗
• MalfunctionNov 17, 2020Device Dislodged or Dislocated

  PATIENT PRESENTED FOR WHAT WAS DESCRIBED AS A COMPLEX ABDOMINAL AORTA ANEURYSM PROCEDURE. IN ADDITION TO USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). IN ADDITION, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES) WAS UTILIZED. AS REPORTED, THE VBX DEVICE WAS ADVANCED TO THE INTENDED LOCATION AND DEPLOYED WITH NO ISSUES. DURING WITHDRAWAL OF THE BALLOON CATHETER, THE SHAFT OF THE BALLOON CATHETER WAS PULLED ABOUT 20-30 CM WHEN THE BALLOON DISLODGED AT THE PROXIMAL END OF THE IBE. USING A SNARE, THE DISLODGED BALLOON WAS REMOVED THROUGH A 12FR SHEATH FROM THE GROIN ACCESS SITE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10857163 ↗

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