GORE VIABAHN VBX Balloon Expandable Endo BXA117902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00733132637768), received between Jul 24, 2018 and Jul 22, 2026 — classified as 1 death, 7 injuries, 16 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2026Device Endoleak

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE TGR 2302AA STUDY AND THE IMEDIDATA DATABASE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND MULTIPLE VBX DEVICES IN THE EXTERNAL ILIAC ARTERIES. THE PROCEDURE WAS A SUCCESS AND NO ENDOLEAKS WERE OBSERVED AT THE CONCLUSION OF THE PROCEDURE. ON (B)(6) 2026 A CT SCAN WAS PERFORMED WHICH IDENTIFIED A TYPE III ENDOLEAK. SEPARATION OF THE TRUNK-IPSI AND THE VBX ON THE LEFT SIDE WAS IDENTIFIED. THE EVENT IS ONGOING. ON (B)(6) 2026 A REINTERVENTION WAS PERFORMED AND AN 11MM X 79MM VBX DEVICE WAS PLACED TO TREAT THE TYPE III ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 25906359 ↗
• InjuryMay 21, 2026Device Endoleak

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN EMERGENT ENDOVASCULAR PROCEDURE TO TREAT A RUPTURED AORTOILIAC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND MULTIPLE VBX DEVICES IN THE LEFT EXTERNAL ILIAC ARTERY. BOTH VBX DEVICES AND THEIR OVERLAP WITH AN INNOVA STENT WERE POST-DILATED. APPROXIMATELY 1.5 CM OF OVERLAP WAS ACHIEVED BETWEEN THE VBX DEVICES AT IMPLANTATION. THE PROCEDURE WAS SUCCESSFUL, AND NO ENDOLEAKS WERE OBSERVED AT COMPLETION. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025 WITHOUT REPORTED COMPLICATIONS. FOLLOW-UP IMAGING INCLUDED AN INITIAL ONE-MONTH SCAN THAT SHOWED NO EVIDENCE OF ENDOLEAK. ON (B)(6) 2026, DURING A SUBSEQUENT CTA (APPROXIMATELY SIX MONTHS LATER), A TYPE IIIA ENDOLEAK WAS IDENTIFIED FOR THE FIRST TIME. IMAGING DEMONSTRATED APPROXIMATELY 2 CM OF SEPARATION BETWEEN THE SECOND AND THIRD VBX DEVICES, MEASURED USING A RULER TOOL ON CTA. THE ENDOLEAK WAS ONGOING AT THAT TIME. THE PHYSICIAN ASSESSED THAT THE LIKELY CAUSE OF THE ENDOLEAK AND DEVICE SEPARATION WAS INSUFFICIENT OVERLAP BETWEEN THE DEVICES IN THE SETTING OF A KNOWN ILIAC ANEURYSM, WHICH LIKELY CONTINUED TO ENLARGE AND CONTRIBUTED TO DEVICE SEPARATION. A REINTERVENTION WAS PE

  Patient problems: Clinical Endoleak

  MAUDE report 25249979 ↗
• InjuryMay 21, 2026Device Endoleak

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN EMERGENT ENDOVASCULAR PROCEDURE TO TREAT A RUPTURED AORTOILIAC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND MULTIPLE VBX DEVICES IN THE LEFT EXTERNAL ILIAC ARTERY. BOTH VBX DEVICES AND THEIR OVERLAP WITH AN INNOVA STENT WERE POST-DILATED. APPROXIMATELY 1.5 CM OF OVERLAP WAS ACHIEVED BETWEEN THE VBX DEVICES AT IMPLANTATION. THE PROCEDURE WAS SUCCESSFUL, AND NO ENDOLEAKS WERE OBSERVED AT COMPLETION. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025 WITHOUT REPORTED COMPLICATIONS. FOLLOW-UP IMAGING INCLUDED AN INITIAL ONE-MONTH SCAN THAT SHOWED NO EVIDENCE OF ENDOLEAK. ON (B)(6) 2026, DURING A SUBSEQUENT CTA (APPROXIMATELY SIX MONTHS LATER), A TYPE IIIA ENDOLEAK WAS IDENTIFIED FOR THE FIRST TIME. IMAGING DEMONSTRATED APPROXIMATELY 2 CM OF SEPARATION BETWEEN THE SECOND AND THIRD VBX DEVICES, MEASURED USING A RULER TOOL ON CTA. THE ENDOLEAK WAS ONGOING AT THAT TIME. THE PHYSICIAN ASSESSED THAT THE LIKELY CAUSE OF THE ENDOLEAK AND DEVICE SEPARATION WAS INSUFFICIENT OVERLAP BETWEEN THE DEVICES IN THE SETTING OF A KNOWN ILIAC ANEURYSM, WHICH LIKELY CONTINUED TO ENLARGE AND CONTRIBUTED TO DEVICE SEPARATION. A REINTERVENTION WAS PE

  Patient problems: Clinical Endoleak

  MAUDE report 25249891 ↗
• MalfunctionApr 6, 2026Premature Separation

  ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT AN GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) PROCEDURE WHERE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED TO BE IMPLANTED IN THE HYPOGASTRIC ARTERY. WHILE ADVANCING THE VBX DEVICE THROUGH AN 8.5 FR MEDTRONIC TOUR GUIDE SHEATH, CONTRALATERALLY, THE VBX DEVICE WAS UNABLE TO REACH THE TARGET TREATMENT AREA AS THERE WAS TORTUOUS ANATOMY ALL AROUND. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE VBX DEVICE BY GOING THROUGH THE SHEATH WHEN THE VBX ENDOPROSTHESIS DISLODGED OFF THE BALLOON CATHETER. THE DISLODGED VBX ENDOPROSTHESIS WAS LEFT IN THE PATIENT AS "ENDO TRASH" AND THE PROCEDURE WAS COMPLETED BY USING A NEW VBX DEVICE. THE PATIENT IS DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 24794293 ↗
• MalfunctionFeb 26, 2026Premature Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE INTERNAL ILIAC ARTERY DURING TREATMENT OF AN ANEURYSM. REPORTEDLY, AFTER THE DEVICE WAS ADVANCED UP AND OVER THE AORTIC BIFURCATION, THE VBX DEVICE GOT TANGLED IN THE ADDITIONAL WIRE USED FOR THROUGH AND THROUGH ACCESS (WIRE WRAP). AFTER MANIPULATING THE DELIVERY CATHETER AND ATTEMPTING TO ADVANCE THE VBX DEVICE, THE PHYSICIAN DECIDED TO REMOVE THE DELIVERY CATHETER. AFTER THE DELIVERY CATHETER WAS REMOVED, THE STENT WAS OBSERVED TO HAVE BECOME DISLODGED AND REMAINED IN THE COMMON ILIAC ARTERY. THE PHYSICIAN WAS ABLE TO SNARE THE STENT FROM THE PATIENT AND SUCCESSFULLY COMPLETE THE PROCEDURE WITH A NEW VBX DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457147 ↗
• MalfunctionJan 8, 2026Deformation Due to Compressive Stress

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A CLINICAL STUDY PATIENT UNDERWENT AN ILIAC BRANCH ENDOPROSTHESIS (IBE) PROCEDURE. DURING THIS PROCEDURE, ENDARTERECTOMY WAS PERFORMED IN LEFT FEMORAL ARTERY, THEN A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WAS IMPLANTED IN THE LEFT EXTERNAL ILIAC ARTERY. NEXT, TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED IN THE BILATERAL COMMON ILIAC ARTERIES. ON DECEMBER 17, 2025, GORE IMAGING DEPARTMENT REPORTED AN OBSERVATION OF A SLIGHT VBX DEVICE COMPRESSION THAT WAS IMPLANTED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY. THE STUDY SITE DID NOT REPORT ANY INTERVENTIONS RELATED TO THIS OBSERVATION AND PATIENT APPEARS TO BE ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24008371 ↗
• MalfunctionDec 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ILIAC ANEURYSM WITH AN GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE DEVICE) AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). REPORTEDLY, AFTER THE IBE DEVICE WAS IMPLANTED, AND THE PHYSICIAN ATTEMPTED TO ADVANCE THE VBX DEVICE THOUGH AN 8FR TERUMO DESTINATION INTRODUCER SHEATH AS A DISTAL EXTENSION TO THE IBE DEVICE. HOWEVER, DURING THE ADVANCEMENT OF THE VBX DEVICE THROUGH THE INTRODUCER SHEATH IT HAD BECOME STUCK. THE PHYSICIAN THEN TRIED TO PULL THE VBX DEVICE BACK OUT OF THE INTRODUCER SHEATH AND IN DOING SO, THE DISTAL PORTION OF THE VBX DELIVERY CATHETER BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823996 ↗
• InjuryOct 29, 2025Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A BILATERAL ILIAC BRANCH ENDOPROSTHESIS (IBE) PROCEDURE WAS PERFORMED DUE TO INFRARENAL AORTIC ANEURYSM AND BILATERAL ILIAC ARTERY ANEURYSMS. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED IN THE RIGHT HYPOGASTRIC ARTERY. AN 8LMM X 79MM VBX DEVICE WAS IMPLANTED DISTALLY AND AN 11MM X 79MM VBX DEVICE IMPLANTED PROXIMALLY AND FLARED TO 14MM INSIDE THE IBE GATE WITH FULL 2.5CM OVERLAP. CONTRAST WAS OBSERVED OUTSIDE OF IBE AND INSIDE IIA ANEURYSM AT THIS TIME, WITH POSSIBLE TYPE III ENDOLEAK. THE PATIENT¿S HYPOGASTRIC ARTERY HAD A 360 DEGREE TURN AND IT WAS STRAIGHTENED WITH A STIFF GUIDEWIRE TO IMPLANT THE VBX DEVICES. ONCE THE STIFF GUIDEWIRE WAS REMOVED THE VESSEL TORTUOSITY RETURNED, POTENTIALLY DISCONNECTING THE VBX DEVICES. ON (B)(6) 2025, REVISION WAS FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE IMPLANTED VBX DEVICES IN THE HYPOGASTRIC ARTERY. ACCESS WAS GAINED FROM THE BRACHIAL ARTERY. A TYPE III ENDOLEAK BETWEEN THE TWO VBX DEVICES WAS CONFIRMED. THE PHYSICIAN CHOSE TO RELINE AND RECONNECT THE VBX DEVICES. AN 8FX90CM TERUMO DESTINATION SHEATH WAS USED TO ADVANCE THE FIRST VBX DEVICE (

  Patient problems: Clinical Endoleak

  MAUDE report 23415038 ↗
• MalfunctionJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT A COVERED ENDOVASCULAR RECONSTRUCTION OF AORTIC BIFURCATION (CERAB) PROCEDURE TO TREAT AORTOILIAC OCCLUSIVE DISEASE (AIOD). A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS SUCCESSFULLY IMPLANTED IN THE DISTAL AORTA. THE PHYSICIAN IMPLANTED THE VBX DEVICE IN THE DISTAL AORTA USING AN 8FR ANSEL GUIDING SHEATH WITH AN UNKNOWN GUIDEWIRE WITH AXILLARY ACCESS. DURING THE REMOVAL OF THE DELIVERY SYSTEM THROUGH THE SHEATH, RESISTANCE WAS ENCOUNTERED, WHERE THE SHEATH WAS TOO TIGHT. WHILE WITHDRAWING THE DELIVERY CATHETER, MODERATE FORCE WAS APPLIED, THOUGH NOT EXCESSIVE. THE DELIVERY CATHETER SUBSEQUENTLY BROKE AT THE SHAFT, WHERE THE BREAKAGE WAS CONTAINED WITHIN THE SHEATH, INSIDE THE PATIENT. THE PHYSICIAN WITHDREW THE SHEATH ALONG WITH THE BROKEN COMPONENTS INSIDE THE SHEATH, ENSURING NO FRAGMENTS REMAINED WITHIN THE PATIENT. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT. THE PHYSICIAN STATED THE 8FR SHEATH WAS INSUFFICIENTLY SIZED FOR THE PROCEDURE AND INDICATED THAT A 9FR SHEATH WOULD HAVE BEEN MORE APPROPRIATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311652 ↗
• InjuryMar 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, PATIENT UNDERWENT TREATMENT FOR A LEFT COMMON ILIAC ANEURYSM UTILIZING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). THE PROCEDURE WAS AN ORIGINAL PHYSICIAN-MODIFIED ENDOVASCULAR GRAFT (PMEG) UTILIZING A COMPETITOR PRODUCT WHICH WAS DONE IN 2024. THE PROCEDURE WAS A PLANNED ILIAC BRANCH PROCEDURE ON THE LEFT UTILIZING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) DUE TO DEGENERATION OF THE LEFT ILIAC SEAL ZONE. THE PHYSICIAN ELECTED TO IMPLANT THE IBE IN A RETROGRADE FASHION ON THE LEFT SIDE. IN ADDITION, THE PHYSICIAN UTILIZED A 10FR GORE® DRYSEAL FLEX INTRODUCER SHEATH TO GO UP AND OVER THE IBE FLOW DIVIDER. THE PROCEDURE WAS GOING AS PLANNED UNTIL THE VBX DEVICE WHICH WAS BEING NAVIGATED INTO POSITION OVER A 260 ROSEN WIRE 0.035" WAS CAUGHT UP IN THE APEX OF THE ANGLE OF THE SHEATH LEADING TO KINKING CAUSING EXTREME FRICTION. IT IS BELIEVED THAT THE FRICTION INHIBITED THE VBX DEVICE FROM NAVIGATING TO ITS TARGET ZONE, AND WHILE TRYING TO PULL THE VBX DEVICE OUT OF THE SYSTEM, THE STENT SLIPPED OFF THE BALLOON. THE VBX BALLOON CATHETER WAS ATTEMPTED TO BE EXCHANGED OUT UNDEPLOYED BECAUSE IT WAS NOT ABLE TO BE ADVANCED. AS THE BALLOON C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684743 ↗
• MalfunctionFeb 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT PRESENTED FOR AN AORTO-ILIAC (UNILATERAL) PROCEDURE. AS REPORTED, THE PATIENT¿S ANATOMY WAS TORTUOUS, AND THE ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS UNABLE TO TRACK TO THE EXTERNAL ILIAC ARTERY. THE IBE WAS WITHDRAWN, AND PHYSICIAN CHOSE TO IMPLANT A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT). AN 8FR CORDIS BRITE TIP SHEATH WAS USED TO ADVANCE THE 11X79 VBX DEVICE. AS REPORTED, THE VBX STENT DISLODGED FROM THE DELIVERY CATHETER WHILE IT WAS INSIDE THE SHEATH. THE CONSTRAINED VBX STENT WAS PUSHED OUT OF THE SHEATH INTO THE ANEURYSM AND REMAINS IN THE PATIENT. THE EXTERNAL ILIAC ARTERY WAS COILED, THEN COVERED WITH AN AORTIC ILIAC COMPONENT (UNSPECIFIED BRAND). THE PROCEDURE WAS COMPLETED WITH GOOD OUTCOME WITH A PATENT ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 21424093 ↗
• MalfunctionJul 11, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT TREATMENT FOR AN ANEURYSM ORIGINATING FROM A PRIOR MEDTRONIC ENDOVASCULAR GRAFT. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE USED. IT WAS REPORTED THAT THE PHYSICIAN EXTENDED THE GRAFT BY USING TWO VBX DEVICES VIA KISSING STENT TECHNIQUE WHERE ONE VBX DEVICE WAS PLACED IN THE RIGHT INTERNAL ILIAC ARTERY AND THE OTHER VBX DEVICE WAS PLACED IN THE RIGHT EXTERNAL ILIAC ARTERY (UNKNOWN WHICH WAS PLACE WHERE). ONE VBX DEVICE HAD AXILLARY ACCESS USING A 90CM 8FR DESTINATION¿ GUIDING SHEATH AND THE OTHER VBX DEVICE HAD A RIGHT COMMON FEMORAL ACCESS SITE USING A 45CM TERUMO DESTINATION¿ GUIDING SHEATH. BOTH SHEATHS WERE USED WITH A BOSTON SCIENTIFIC AMPLATZ GUIDEWIRE. WHEN THE PHYSICIAN WAS ADVANCING THE VBX DEVICE THAT HAD THE AXILLARY ACCESS, THEY MET WITH SOME RESISTANCE. THEY DID A NEGATIVE PULL BACK TO EASE WITH THE ADVANCEMENT, HOWEVER, RESISTANCE REMAINED THE SAME. REPORTEDLY, THERE WAS NO POST DILATION DONE ON EITHER VBX DEVICE. WHEN, THE PHYSICIAN WAS READY TO REMOVE THE BALLOONS, THEY FIRST DEFLATED THE BALLOONS BUT EXPERIENCED A LOT OF RESISTANCE WHEN TRYING TO PIN AND PULL O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19724501 ↗
• MalfunctionJul 11, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024 THE PATIENT UNDERWENT TREATMENT FOR AN ANEURYSM ORIGINATING FROM A PRIOR MEDTRONIC ENDOVASCULAR GRAFT. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE USED. IT WAS REPORTED THAT THE PHYSICIAN EXTENDED THE GRAFT BY USING TWO VBX DEVICES VIA KISSING STENT TECHNIQUE WHERE ONE VBX DEVICE WAS PLACED IN THE RIGHT INTERNAL ILIAC ARTERY AND THE OTHER VBX DEVICE WAS PLACED IN THE RIGHT EXTERNAL ILIAC ARTERY (UNKNOWN WHICH WAS PLACE WHERE). ONE VBX DEVICE HAD AXILLARY ACCESS USING A 90CM 8FR DESTINATION¿ GUIDING SHEATH AND THE OTHER VBX DEVICE HAD A RIGHT COMMON FEMORAL ACCESS SITE USING A 45CM TERUMO DESTINATION¿ GUIDING SHEATH. BOTH SHEATHS WERE USED WITH A BOSTON SCIENTIFIC AMPLATZ GUIDEWIRE. WHEN THE PHYSICIAN WAS ADVANCING THE VBX DEVICE THAT HAD THE AXILLARY ACCESS, THEY MET WITH SOME RESISTANCE. THEY DID A NEGATIVE PULL BACK TO EASE WITH THE ADVANCEMENT, HOWEVER, RESISTANCE REMAINED THE SAME. REPORTEDLY, THERE WAS NO POST DILATION DONE ON EITHER VBX DEVICE. WHEN, THE PHYSICIAN WAS READY TO REMOVE THE BALLOONS, THEY FIRST DEFLATED THE BALLOONS BUT EXPERIENCED A LOT OF RESISTANCE WHEN TRYING TO PIN AND PULL OU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19724356 ↗
• MalfunctionJun 25, 2024Break; Device Dislodged or Dislocated; Premature Separation; Break; Device Dislodged or Dislocated; Premature Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT HAD AN ENDOVASCULAR PROCEDURE TO TREAT AN AORTOILIAC ANEURYSM WITH A POSSIBLE TYPE 1 B ENDOLEAK ON A PREVIOUSLY IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS (EXCLUDER). THE EXCLUDER WAS IMPLANTED IN 2022 AND THERE ARE NO CT IMAGES TO CONFIRM THE ENDOLEAK. A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS IMPLANTED WITHOUT ISSUE. IN ADDITION, A 11 MM X 79 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT GRAFT) WAS INTENDED FOR USE IN THE RIGHT HYPOGASTRIC ARTERY AS AN EXTENSION OF THE IBE. IT WAS REPORTED THAT ACCESS WAS GAINED THROUGH THE LEFT BRACHIAL ARTERY AND A 0.035¿ CORDIS STORQ STEERABLE GUIDEWIRE WAS USED. REPORTEDLY, THERE WAS DIFFICULTY WITH ADVANCEMENT OF VBX STENT GRAFT DELIVERY CATHETER THROUGH A UPSIZED 9 F COOK INTRODUCER SHEATH, THE EXCLUDER, THE IBE, AND THE PATIENT¿S TORTUOUS ANATOMY. CONSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE VBX STENT GRAFT DELIVERY CATHETER PRIOR TO DEPLOYMENT TO POSSIBLY USE A 11 MM X 59 MM INSTEAD TO HAVE BETTER TRACKABILITY. IT WAS NOTED, THAT WHEN THE PHYSICIAN PULLED BACK ON THE VBX STENT GRAFT DELIVERY CATHETER HUB WITH NORMAL FORCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610890 ↗
• DeathMay 22, 2024Adverse 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) 2024, A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE DEVICE), THREE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) AND A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WERE IMPLANTED DURING TREATMENT OF A COMMON ILIAC ARTERY ANEURYSM. DURING THE INITIAL CONTRAST RUN BLUSHING WAS IDENTIFIED OUTSIDE THE ARTERY. THE IBE DEVICE WAS SUCCESSFULLY IMPLANTED, A VBX DEVICE WAS SUCCESSFULLY IMPLANTED INTO THE FLOW DIVIDER OF THE IBE, TWO VBX DEVICES WERE PLACED AS EXTENSIONS ON ITHER SIDE. A VSX DEVICE WAS PLACED AS AN EXTENSION OF THE VBX DEVICE. A POST IMPLANT CONTRAST RUN WAS PERFORMED, AND EVERYTHING APPEARED TO BE GOOD. HOWEVER, SHORTLY AFTER THE PATIENT'S BLOOD PRESSURE DROPPED, AND THE PHYSICIAN SUSPECTED THAT THE AORTA HAD RUPTURED AND ATTEMPTED AN AORTIC BYPASS WITH A NONE GORE DEVICE. DURING THE ATTEMPTED AORTIC BYPASS, THE PATIENT EXPIRED. PRIOR TO THE PROCEDURE, ON AN UNKNOWN DATE THE PATIENT WAS IMPLANTED WITH A BARE METAL STENT IN THE ABDOMINAL AORTA. THE REASON FOR THE TREATMENT WAS UNKNOWN.

  Patient problems: Clinical Endoleak

  MAUDE report 19373298 ↗
• MalfunctionMar 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: PATIENT PRESENTED WITH BILATERAL STENOTIC OCCLUSIONS IN THE ILIAC ARTERIES. DURING TREATMENT, ACCESS WAS MADE AT THE COMMON FEMORAL ARTERIES. REPORTEDLY, THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY PRE DILATE THE TARGET TREATMENT AREA. A SHORT 8FR TERUMO DESTINATION SHEATH WAS USED TO ADVANCE THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) FOR TREATMENT IN THE LEFT COMMON ILIAC ARTERY. HOWEVER, THE VBX DEVICE WAS UNABLE TO CROSS THE LESION. CONSEQUENTLY, THE VBX DEVICE WAS BEING PULLED BACK INTO THE SHEATH WHEN THE STENT DISLODGED FROM THE DELIVERY CATHETER. THE VBX DEVICE LANDED IN THE EXTERNAL ILIAC ARTERY WITH NO BRANCH CONVERGE. THE DELIVERY CATHETER WAS REMOVED AND A SMALL BALLOON WAS INSERTED INTO THE CONSTRAINED STENT TO MOVE THE STENT TO THE INTENDED TREATMENT SITE. ONCE THE STENT WAS PLACED, A LARGER BALLOON WAS USED TO COMPLETELY EXPAND THE VBX DEVICE. THE PROCEDURE CONTINUED WITH IMPLANTATION OF ADDITIONAL VBX DEVICES IN THE RIGHT AND LEFT LEG WITH NO FURTHER ISSUES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18871461 ↗
• InjuryJun 9, 2023Leak/Splash; Leak/Splash

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT PRESENTED WITH A TYPE 1B ENDOLEAK IN THE LEFT COMMON ILIAC ARTERY FROM A PREVIOUSLY IMPLANTED MEDTRONIC ENDOVASCULAR DEVICE TO TREAT AN AORTIC ANEURYSM. TO PRESERVE THE LEFT HYPOGASTRIC ARTERY AND TO TREAT THE TYPE 1B ENDOLEAK A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS IMPLANTED. ON (B)(6) 2023, THE PATIENT HAD NOTED LEFT HYPOGASTRIC ARTERY ENLARGEMENT AND AN ENDOLEAK FROM THE PREVIOUSLY IMPLANTED GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). THE PHYSICIAN CHOSE TO COIL EMBOLIZE THE LEFT HYPOGASTRIC ARTERY TO TREAT THE ENDOLEAK. THE ENDOLEAK WAS REPORTEDLY RESOLVED AT THE END OF THE CASE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17098722 ↗
• MalfunctionAug 9, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT TREATMENT FOR A STENOTIC LESION IN THE ILIAC ARTERY USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. WHILE THE DEVICE WAS BEING ADVANCED THE STENT GRAFT SEPARATED FROM THE DELIVERY CATHETER IN THE PATIENT'S ILIAC ARTERY. IT WAS REPORTED THE PHYSICIAN WAS ABLE TO ADVANCE A BALLOON INTO THE DEVICE TO SUCCESSFULLY COMPLETE THE DEPLOYMENT IN THE INTENDED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15196034 ↗
• MalfunctionOct 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE WAS INTENDED FOR USE IN THE LEFT COMMON ILIAC ARTERY. AFTER THE VBX DEVICE WAS SUCCESSFULLY DELIVERED IN THE LEFT COMMON ILIAC THROUGH A 8FR X 90 TERUMO INTRODUCER SHEATH IN RIGHT BRACHIAL ARTERY. THE VBX DELIVERY CATHETER BROKE NEAR THE HANDLE AS IT WAS BEING REMOVED BY THE PHYSICIAN. THE REMAINING DELIVERY CATHETER WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Stenosis

  MAUDE report 12707790 ↗
• MalfunctionMay 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT PRESENTED WITH THROMBUS AND CALCIUM IN A PREVIOUSLY PLACED STENT (MEASURED AT 9MM) IN THE LEFT ILIAC ARTERY AND UNDERWENT TREATMENT UTILIZING A 11MM X 79MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX). THE PHYSICIAN USED A ANGIOJET¿ THOMBECTOMY SYSTEM AND THEN ADVANCED THE VBX DEVICE OVER AN ADVANTAGE GLIDEWIRE THROUGH A 8FR TRUMEAU CATHETER FROM THE ARM DOWN TO THE PREVIOUSLY PLACED STENT IN THE LEFT ILIAC ARTERY. THE PHYSICIAN INFLATED THE VBX DEVICE TO 5ATM AND INTENDED TO USE A DIFFERENT BALLOON BELOW THE RENAL ARTERIES NEXT BUT BEFORE THAT COULD BE PERFORMED THE VBX DEVICE AND BALLOON INFLATED TO 5ATM WERE UNINTENTIONALLY PULLED UP TOWARD THE RENAL ARTERIES. THE PHYSICIAN THEN WENT IN FROM THE GROIN WITH A 12MM X 4MM BALLOON AND PULLED THE VBX DEVICE BACK INTO IT'S INTENDED POSITION. THE PATIENT TOLERATED THE PROCEDURE. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11902217 ↗
• MalfunctionMay 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2021 AN 11MM X 79MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS TO BE PLACED AS A EXTENSION OF A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS INTO THE INTERNAL ILIAC. DURING THE ADVANCEMENT OF THE VBX DEVICE UP AND OVER THE AORTIC BIFURCATION THE VBX DEVICE HAD BECOME STUCK IN THE INTRODUCER SHEATH (MANUFACTURER UNKNOWN). THE PHYSICIAN REMOVED THE DELIVERY CATHETER FROM THE INTRODUCER SHEATH AND NOTICED THAT THE DEVICE HAD BECOME DISLODGED IN THE INTRODUCER SHEATH. THE SHEATH WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ADDITIONAL VBX DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Aneurysm

  MAUDE report 11780678 ↗
• MalfunctionJul 20, 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 TREATMENT OF AN ILIAC ARTERY ANEURYSM WITH AN UNKNOWN ILIAC BRANCH DEVICE. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS INTENDED TO BE PLACED IN THE INTERNAL ILIAC ARTERY FROM AN IPSILATERAL APPROACH. THE DEVICE WAS ATTEMPTED TO BE ADVANCED OVER A .035" ROSEN WIRE. UPON LOADING THE DEVICE, OUTSIDE THE PATIENT, THE DELIVERY CATHETER BECAME ACCORDIONED. THIS DEVICE WAS DISCARDED. THE GUIDEWIRE WAS EXCHANGED FOR A .035" ADVANTAGE WIRE. ANOTHER GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS ADVANCED OVER THE WIRE THROUGH A 14.5FR APTUS TOUR GUIDE SHEATH, THROUGH THE ILIAC BRANCH DEVICE, TOWARD THE INTERNAL ILIAC ARTERY, HOWEVER THE DEVICE COULD NOT TRACK OVER THE TIGHT TURN OF THE ANATOMY. THIS DEVICE WAS ATTEMPTED TO BE WITHDRAWN BUT IN DOING SO, THE DEVICE CAME OFF THE BALLOON CATHETER. A 4 MM BALLOON CATHETER WAS ADVANCED THROUGH THE DEVICE AND INFLATED IN ORDER TO ANCHOR THE STENT AND REMOVE IT FROM THE PATIENT. A THIRD GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS ADVANCED OVER THE WIRE THROUGH THE 14.5FR APTUS TOUR GUIDE SHEATH, THROUGH THE ILIAC BRANCH DEVIC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809919 ↗
• InjuryJul 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: DURING AN ILIAC BRANCH PROCEDURE, ACCESS MADE FROM THE BRACHIAL ARTERY FOR TREATMENT IN THE HYPOGASTRIC ARTERY. AS REPORTED, THE PATIENT HAD A TORTUOUS ANATOMY, PLUS EXISTING ABDOMINAL GRAFTS AND A STENTS IN THE INTERNAL ILIAC ARTERY. A 9FR X 55CM COOK SHEATH WAS USED TO ADVANCE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) OVER A STIFF ANGLED TERUMO GLIDEWIRE. DIFFICULTIES WERE ENCOUNTERED WHILE ADVANCING THE VBX DEVICE THROUGH THE SHEATH, AND THE VBX DEVICE WAS UNABLE TO ACCESS THE HYPOGASTRIC ARTERY. THE VBX DEVICE WAS WITHDRAWN AND THE WIRE WAS EXCHANGED TO AN AMPLATZ SUPER STIFF GUIDEWIRE. THE SAME VBX DEVICE WAS ADVANCED AGAIN AND IT REACHED THE INTENDED TREATMENT SITE. WHEN THE BALLOON WAS INFLATED, IT WAS NOTICED THE VBX STENT HAD DISLODGED FROM THE BALLOON CATHETER. THE STENT WAS AT THE DISTAL END OF THE SHEATH. THE CONSTRAINED VBX DEVICE WAS SNARED AND REMOVED THROUGH THE GROIN ACCESS. FROM THE BRACHIAL ARTERY ACCESS, A NEW VBX DEVICE WAS ADVANCED AND DEPLOYED WITH GOOD RESULTS. THE PATIENT IS REPORTED TO RECOVERING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 8762746 ↗
• MalfunctionJul 24, 2018Material Separation; Material Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT WITH A PREVIOUSLY IMPLANTED MEDTRONICS DEVICE WAS UNDERGOING TREATMENT OF A THORACO-ABDOMINAL AORTIC DISSECTION WITH ADDITIONAL NON-GORE AORTIC COMPONENTS. (TAPERED VALIANT AND ENDOLOGICS DEVICES). THE SMA AND CELIAC ARTERIES WERE TREATED IN SNORKEL TECHNIQUE WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES. FOLLOWING PLACEMENT OF THE TAPERD VALIANT DEVICE, THE VBX DEVICES WERE ADVANCED OVER .035" BOSTON SCIENTIFIC/AMPLATZ SUPERSTIFF WIRES THROUGH AN 8FR. TERUMO DESTINATION SHEATH, FROM RIGHT BRACHIAL ACCESS, TO THE SMA AND CELIAC ARTERIES. THEN THE ENDOLOGICS DEVICE WAS ADVANCED AND DEPLOYED. NEXT THE VBX DEVICES WERE BALLOON EXPANDED. AFTER THIS, IT WAS NOTICED BOTH BALLOON CATHETERS BROKE, IN THE SAME REGION, APPROXIMATELY 5CM FROM THE HUB OF THE CATHETER. THE CATHETER SEGMENT FROM THE SMA TREATMENT SITE WAS ABLE TO BE REMOVED WITH THE SHEATH OVER THE WIRE, HOWEVER THE CATHETER SEGMENT FROM THE CELIAC TREATMENT SITE BECAME STUCK ON THE WIRE SO THE SHEATH, WIRE AND CATHETER SEGMENT WERE ALL REMOVED. SHEATH ACCESS WAS RE-GAINED AND THE PROCEDURE ENSUED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7716301 ↗

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