GORE VIABAHN VBX Balloon Expandable Endo BXA083902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00733132637317), received between Sep 18, 2018 and Jan 23, 2025 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, AN 8 MM X 39 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS VBX DEVICE WAS INTENDED FOR USE IN THE ILIAC ARTERY DURING TREATING OF STENOSIS. THE PHYSICIAN WAS UNABLE TO ADVANCE THE 8 MM X 39 MM VBX DEVICE ACROSS A COMMON ILIAC STENOSIS. WHEN RETRACTING THE STENT BACK INTO A 7FR CORDIS BRIGHT TIP SHEATH, THE STENT DISLODGED FROM THE DELIVERY CATHETER AND MIGRATED INTO THE EXTERNAL ILIAC. THE 0.035" X 300 CM SUPRACORE GUIDE WIRE WAS EXCHANGED FOR AN 0.014" GUIDE WIRE AND A 7 MM X 30 MM BALLOON WAS INSERTED INTO THE UNDEPLOYED STENT AND INFLATED TO DEPLOY THE STENT INTO THE EXTERNAL ILIAC. A SECOND VBX DEVICE WAS DEPLOYED INTO THE COMMON ILIAC TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218823 ↗
• MalfunctionMay 16, 2024Difficult to Remove; Malposition of Device; Difficult to Advance; Premature Separation; Difficult to Remove; Malposition of Device; Difficult to Advance; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT TREATMENT FOR ILIAC OCCLUSION WHERE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS USED. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO CROSS THE LESION FROM A CONTRALATERAL APPROACH USING A 7FR TERUMO DESTINATION SHEATH AND A .035" ROSEN GUIDEWIRE BUT WAS NOT SUCCESSFUL AS THERE WAS RESISTANCE WHILE ADVANCING. THE ACCESS POINT WAS THE RIGHT COMMON FEMORAL. IT WAS NOTED THAT THERE WAS A LARGE AMOUNT OF CALCIFICATION PRESENT. SOME FORCE WAS USED TRYING TO ADVANCE THE VBX DEVICE ACROSS THE LESION BUT IT WAS UNSUCCESSFUL. RESISTANCE WAS NOTED WHILE TRYING TO RE-SHEATH THE DEVICE AND THE VBX DEVICE DISLODGED FROM THE BALLOON CATHETER PRIOR TO DEPLOYMENT. REPORTEDLY, THE VBX DEVICE DISLODGED AT THE ILIAC BIFURCATION AND WAS PULLED BACK TO LEFT COMMON ILIAC. THE PROCEDURE WAS COMPLETED BY DEPLOYING AND ADDITIONAL VBX DEVICE AND TRAPPING THE UNDEPLOYED VBX DEVICE AGAINST THE VESSEL WALL. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19335757 ↗
• MalfunctionApr 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024, THE PATIENT UNDERWENT A KISSING STENT PROCEDURE TO TREAT HEAVILY STENOTIC (CALCIFIED AND OCCLUDED) COMMON ILIAC ARTERIES WHERE AN 8 MM X 39 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS GOING TO BE USED IN A TOTALLY OCCLUDED LEFT COMMON ILIAC ARTERY. IT WAS REPORTED THE PHYSICIAN HAD BILATERAL GROIN ACCESS. SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) WAS USED AT THE TARGET TREATMENT SITE. A SHORT TERUMO INTRODUCER SHEATH WAS USED OVER A SHORT TIP AMPLATZ SUPER STIFF¿ GUIDEWIRE (SIZE NOT PROVIDED). REPORTEDLY, THE INTRODUCER SHEATH WOULD NOT REACH THE TARGET TREATMENT AREA, SO IT WAS WITHDRAWN AND THE DECISION WAS MADE TO ATTEMPT TO ADVANCE THE DELIVERY CATHETER WITHOUT AN INTRODUCER SHEATH. RESISTANCE WAS MET DUE TO CALCIFICATION AND THE DELIVERY CATHETER WOULD NOT ADVANCE FURTHER. THE DECISION WAS MADE TO WITHDRAW THE DELIVERY CATHETER TO USE THE SHOCKWAVE IVL AGAIN. DURING WITHDRAWAL, THE ENDOPROSTHESIS DISLODGED FROM THE DELIVERY CATHETER AND LANDED IN THE LEFT EXTERNAL ILIAC ARTERY. IT WAS REPORTED THIS AREA WAS DISEASED AS WELL, THUS A SECONDARY BALLOON CATHETER WAS ADVANCED AND THE ENDOPROSTHESIS WAS DEPLOYED. THE DELIVERY CATHETER WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19112372 ↗
• MalfunctionMar 28, 2024Migration; Migration

  ON (B)(6), 2023, A STUDY PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) IN THE AAA1701 TAMBE PIVOTAL STUDY. DURING THIS TREATMENT, MULTIPLE 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; 2), LEFT RENAL ARTERY (3), CELIAC ARTERY (1) AND RIGHT RENAL ARTERY (4). ON (B)(6), 2023, CTA IMAGING WAS PERFORMED. RESULTS SHOWED A VBX DEVICE THAT HAD BEEN IMPLANTED IN THE RIGHT RENAL ARTERY AS A DISTAL EXTENSION WITHIN THE PORTAL WAS FOUND IN THE ANEURYSM SAC. THE REPORT STATED THE FOURTH RIGHT RENAL ARTERY SIDE BRANCH COMPONENT IS PRESENT, FULLY DEPLOYED, WITHIN THE ANEURYSM SAC AND IS NOT CONNECTED TO ANY ADDITIONAL COMPONENTS OF THE TAMBE SYSTEM OF DEVICES. IT FOLLOWS THE LEFT RENAL ARTERY SIDE BRANCH COMPONENT AND CONTINUES APPROXIMATELY 2CM DISTAL OF THE LEFT RENAL ARTERY. INTERVENTION, WAS NOT REPORTED AND PATIENT APPEARS TO BE ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000668 ↗
• MalfunctionFeb 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE BY THE FIELD SALES ASSOCIATE: ON (B)(6) 2024, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS IMPLANTED IN THE LEFT ILIAC ARTERY TO TREAT VESSEL STENOSIS. IT WAS REPORTED THAT A 8 MM X 39 MM VBX DEVICE WAS ADVANCED ONTO AN UNKNOWN SIZE/BRAND GUIDEWIRE, AND THROUGH AN UNKNOWN SIZE/BRAND INTRODUCER SHEATH WITHOUT DIFFICULTY. HOWEVER, THE VBX DEVICE DELIVERY CATHETER WAS UNABLE TO ADVANCE ACROSS THE TARGET LESION. CONSEQUENTLY, THE PHYSICIAN DECIDED TO WITHDRAW THE VBX DEVICE. REPORTEDLY, THE VBX DEVICE WAS WITHDRAWN INTO THE INTRODUCER SHEATH (NOT IN TANDEM) AND THE VBX DEVICE STENT GRAFT BECAME DISLODGED. THE PHYSICIAN WAS ABLE TO DEPLOY THE DISLODGED VBX DEVICE STENT GRAFT WITH AN UNKNOWN BRAND PTA BALLOON INTO THE LEFT ILIAC ARTERY. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18806894 ↗
• MalfunctionJun 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE LEFT COMMON ILIAC ARTERY (LCIA) FOR STENOSIS. THE PHYSICIAN REPORTEDLY PREDILATED THE PATIENT'S LESION WITH A PTA BALLOON ADVANCED OVER A 0.035" GLIDEWIRE THROUGH A CORDIS 7 FR INTRODUCER SHEATH. IT WAS NOTED, THERE WAS FAILURE OF THE VBX DEVICE TO ADVANCE PAST THE LESION. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE VBX DEVICE BACK THROUGH THE INTRODUCER SHEATH, AT THAT TIME THE VBX STENT DISLODGED AT THE TIP OF THE INTRODUCER SHEATH. THE PHYSICIAN WAS ABLE TO PARTIALLY DEPLOY THE VBX DEVICE STENT WITH A SMALL PTA BALLOON. ULTIMATELY, THE PHYSICIAN ADVANCED ANOTHER PTA BALLOON AND SUCCESSFULLY IMPLANTED THE VBX DEVICE IN THE LEFT EXTERNAL ILIAC ARTERY (LEIA). THE PROCEDURE WAS COMPLETED WITH ANOTHER GORE DEVICE (UNKNOWN PRODUCT) IN THE INTENDED LOCATION OF THE LCIA. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153324 ↗
• MalfunctionFeb 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE COMMON ILIAC FOR PERIPHERAL ARTERY DISEASE. THE PHYSICIAN INITIATED THIS PROCEDURE WITH OPEN FEMORAL ACCESS. THE PHYSICIAN ATTEMPTED TO ADVANCE THE VBX DEVICE ACROSS THE LESION THROUGH A 7FR X 10CM TERUMO SHEATH OVER A 180CM GUIDEWIRE (MANUFACTURER UNKNOWN). CONSEQUENTLY, IT WAS NOTED THAT THE GUIDEWIRE WAS NOT LONG ENOUGH TO ADVANCE THE VBX DEVICE ACROSS THE LESION. THE PHYSICIAN ATTEMPTED TO RETRACT THE VBX DEVICE THROUGH THE INTRODUCER SHEATH AND THE STENT WAS CAUGHT ON THE EDGE OF THE SHEATH AND DISLODGED. DUE TO THE CUT DOWN ACCESS ALREADY AVAILABLE IN THE FEMORAL ARTERY THE PHYSICIAN WAS ABLE TO REMOVE THE VBX DEVICE FROM THE PATIENT WITH FORCEPS WITHOUT ANY ADDITIONAL HARM TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER VBX DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 16330196 ↗
• MalfunctionDec 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  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 COMMON ILIAC FOR TREATMENT OF BILATERAL ILIAC ANEURYSMS. DURING ADVANCEMENT OF THE VBX DEVICE UP AND OVER THE AORTIC BIFURCATION, THROUGH A 7FR INTRODUCER SHEATH (MANUFACTURER UNKNOWN) OVER A 0.035" GUIDE WIRE (MANUFACTURER UNKNOWN) THE DEVICE HAD BECOME STUCK IN THE INTRODUCER SHEATH. THE PHYSICIAN DECIDED TO USE FORCEPS TO GRIP THE DELIVERY CATHETER AND FORCE THE DEVICE THROUGH THE INTRODUCER SHEATH. AFTER THE DEVICE WAS ADVANCED ACROSS THE LESION, DEPLOYMENT WAS INITIATED. HOWEVER, THE VBX DEVICE WAS UNABLE TO DEPLOY, AND THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE THROUGH THE INTRODUCER SHEATH BUT MET RESISTANCE. THE DECISION WAS MADE TO CUT THE DELIVERY CATHETER AND INTRODUCER SHEATH TO ENABLE A LARGER FR INTRODUCER SHEATH TO ADVANCE OVER THE DELIVERY SYSTEM AND CAPTURE THE VBX DEVICE. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO PULL THE VBX DEVICE THROUGH THE LARGER SHEATH, THE DEVICE HAD BECOME DISLODGED. BOTH SHEATHS, DELIVERY CATHETER AND GUIDE WIRE WERE REMOVED FROM THE PATIENT. AN 0.014" GUIDE WIRE (MANUFACTURER UNK

  Patient problems: Aneurysm

  MAUDE report 15983280 ↗
• MalfunctionAug 29, 2022Difficult to Insert; Premature Separation; Difficult to Insert; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON AN UNKNOWN DATE, A PATIENT PRESENTED FOR TREATMENT OF A SPLENIC ARTERY ANEURYSM UTILIZING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE. IT WAS REPORTED BY THE PHYSICIAN THAT THE PATIENTS VESSEL WAS A VERY TIGHT FIT FOR THE VBX DEVICE AND IT TOOK MORE FORCE THAN USUAL TO ADVANCE. DURING ADVANCEMENT, THE VBX DEVICE BECAME DISLODGED FROM THE BALLOON. THE VBX DEVICE REMAINS IN THE PATIENT AND A FOLLOW-UP PROCEDURE TO COIL OFF THE ANEURYSM AND COMPLETE TREATMENT IS SCHEDULED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15314163 ↗
• MalfunctionSep 21, 2021Premature Separation; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A PATIENT PRESENTED WITH COMMON ILIAC STENOSIS AND UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE VBX DEVICE PAST THE END OF AN 8 FR SHEATH IN AN ATTEMPT TO REPOSITION THE SHEATH. THE PHYSICIAN THEN ATTEMPTED TO WITHDRAW THE VBX DEVICE BACK THROUGH THE SHEATH, AT WHICH POINT THE UNDEPLOYED STENT DISLODGED FROM THE DELIVERY CATHETER. A SECOND VBX DEVICE WAS THEN SUCCESSFULLY DEPLOYED OVER THE DISLODGED STENT, REPORTEDLY ALSO COVERING THE INTENDED LESION. THE PATIENT TOLERATED THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12505625 ↗
• MalfunctionJun 29, 2021Premature Separation; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT PRESENTED WITH CALCIFICATION IN THE COMMON ILIAC AND UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX). THE PHYSICIAN WAS ATTEMPTING TO ADVANCE THE VBX OVER A BIFURCATION BUT MET RESISTANCE. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE DEVICE AND AS IT WAS BEING PULLED BACK THROUGH THE SHEATH, THE UNDEPLOYED STENT FELL OFF THE SHAFT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY RECAPTURE AND REMOVE THE STENT WITH A SNARE. THE DEVICE WAS DISCARDED. THE PROCEDURE WAS COMPLETED USING ANOTHER VBX DEVICE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN SUSPECTED THAT PULLING THE DEVICE BACK INTO THE SHEATH IS WHAT CAUSED THE ISSUE. PATIENT INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12083962 ↗
• InjuryApr 15, 2021Disconnection; Disconnection

  'CHIMNEY STENT GRAFT FOR LEFT SUBCLAVIAN ARTERY PRESERVATION DURING THORACIC ENDOGRAFT PLACEMENT' ANDRE RAMDON, MBBS, RAMKRISHNA PATEL, MD, JEFFREY HNATH, MD, CHIN-CHIN YEH, MD, AND R. CLEMENT DARLING III, MD, ALBANY, NY. A RETROSPECTIVE REVIEW OF A SINGLE VASCULAR SURGERY REGISTRY BETWEEN FEBRUARY 2011 AND SEPTEMBER 2017 WAS PERFORMED OF ALL LEFT SUBCLAVIAN REVASCULARIZATION DURING ELECTIVE TEVAR. ARCH RECONSTRUCTIONS INVOLVING MORE THAN JUST THE LEFT SUBCLAVIAN ARTERY WERE EXCLUDED. INDICATIONS, DEMOGRAPHICS, PROCEDURAL DETAILS, AND OUTCOMES WERE ANALYZED USING STANDARD STATISTICAL ANALYSIS. THERE WAS ONE TYPE IA OR GUTTER LEAK DETECTED FEW MONTHS AFTER THE STUDY COMPLETION DATE (10 MONTHS AFTER IMPLANTATION) RESULTING FROM FORESHORTENING OF THE VBX STENT. THE BALLOON-EXPANDABLE 7-MM STENT WAS BALLOONED TO 8 MM DURING THE INITIAL CASE WITHOUT ANY EVIDENCE OF ENDOLEAK. IN RETROSPECT, THE LARGEST PORTION OF THE IMPLANTED VESSEL MEASURED 11 MM. BECAUSE THE STENT CO-OPTED TO THE NATIVE VESSEL, IT LOST SOME OF THE OVERLAP WITH THE TEVAR AND HENCE THE ENDOLEAK. THIS WAS TREATED WITH EXTENSION AND REDILATION TO APPROPRIATE SIZE, WITH CONTINUED PATENCY OF THE LEFT VERTEBRAL ARTERY.

  Patient problems: Aneurysm

  MAUDE report 11672702 ↗
• MalfunctionSep 25, 2020Deflation Problem; Deflation Problem

  DURING A PROCEDURE TO TREAT A FISTULA IN THE PATIENT'S LEFT CEPHALIC VEIN OUTFLOW STENOSIS, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS IMPLANTED AT THE INTENDED TREATMENT SITE. AFTER DEPLOYMENT, THE BALLOON COULD NOT BE DEFLATED. AS A RESULT, BALLOON WAS OVERINFLATED IN ORDER TO BURST THE BALLOON. THE BALLOON AND CATHETER WERE THEN REMOVED WITH NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10590522 ↗
• MalfunctionFeb 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO THE GORE FSA FROM THE DOCTOR: THE PATIENT PRESENTED FOR LEFT COMMON ILIAC ARTERY DISEASE TREATMENT. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS ADVANCED TO THE LESION AND DEPLOYED WITHOUT ISSUE. HOWEVER, THE BALLOON WOULD NOT DEFLATE. SEVERAL ATTEMPTS TO DEFLATE THE BALLOON WERE MADE VIA ARM ACCESS FIRST USING A LASER AND THEN A BILIARY PUNCTURE NEEDLE WITHOUT SUCCESS. THE DOCTOR DECIDED TO INFLATE THE BALLOON TO 20 ATMOSPHERE WHICH POPPED THE BALLOON. THE BALLOON WAS ABLE TO BE REMOVED AT THAT TIME. THE VESSEL WAS SUCCESSFULLY RELINED WITH AN 8X59 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE PATIENT IS FINE. THE BALLOON AND CATHETER IS AVAILABLE FOR EXAMINATION.

  Patient problems: No Information

  MAUDE report 9740834 ↗
• MalfunctionNov 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019 A PATIENT WAS UNDERGOING VASCULAR TREATMENT OF BOTH COMMON ILIAC ARTERIES WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES. THE INTENT WAS TO POSITION THE DEVICES IN KISSING TECHNIQUE. THE ANATOMYWAS DESCRIBED AS "MINIMALLY TORTUOUS". ONE OF THE VBX DEVICES (8MM X 39MM) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LOCATION. AS IT WAS BEING PUSHED THROUGH THE OCCLUDED AREA, WHICH HAD NOT BEEN PRE-DILATED, IT WAS REALIZED THE STENT WAS THE WRONG SIZE. THIS DEVICE WAS ATTEMPTED TO BE REMOVED, BUT WHEN IT WAS BEING PULLED BACK, THE STENT CAME OFF THE BALLOON CATHETER. THIS STENT WAS THEN EXPANDED WITH ANOTHER BALLOON CATHETER TO DILATE IT. A LONGER (8MM X 59MM) GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS THEN ADVANCED THROUGH THE FIRST STENT AND DEPLOYED TO COMPLETE THE LENGTH OF THE TREATMENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9370687 ↗
• 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 ST

  Patient problems: Occlusion

  MAUDE report 9321253 ↗
• MalfunctionSep 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT WAS UNDERGOING TREATMENT OF A RIGHT COMMON ILIAC ARTERY LESION WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. ACCESS WAS OBTAINED FROM THE LEFT GROIN WITH A 7FR ANSEL SHEATH OVER A STIFF .035" AMPLATZ WIRE. THE DEVICE WAS ATTEMPTED TO BE ADVANCED IN AN UP AND OVER THE AORTIC BIFURCATION FASHION, BUT IT COULD NOT BE ADVANCED PAST THE LEFT COMMON ILIAC ARTERY. THE DEVICE WAS REMOVED THROUGH THE SHEATH. WIRE ACCESS WAS PRESERVED. THE SHEATH WAS EXCHANGED FOR A SHORTER (10CM) 8FR SHEATH, AND THE DEVICE WAS ADVANCED, BUT BECAME STUCK IN THE LEFT COMMON ILIAC ARTERY. THE DEVICE WAS ATTEMPTED TO BE WITHDRAWN THROUGH THE SHEATH, HOWEVER THE UNDEPLOYED STENT BECAME SEPARATED FROM THE BALLOON CATHETER, LANDING IN THE LEFT COMMON ILIAC ARTERY. THE BALLOON CATHETER WAS REMOVED AND A SNARE WAS ADVANCED TO CAPTURE THE STENT, WHICH WAS SUCCESSFUL. A DECISION WAS MADE TO POSTPONE THIS TREATMENT. ON (B)(6) 2018 THE PATIENT WAS TREATED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7887499 ↗

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