Endurant® II ETLW1624C124E (UDI 00643169467507)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00643169467507), received between Feb 21, 2017 and Jun 12, 2026 — classified as 2 deaths, 26 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (19 reports).

6 other recalls cover devices cleared under the same FDA submission (P100021); 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 33 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY TO THE EMERGENCY ROOM WITH PAIN. CT SHOWED AND AN ABDOMINAL AORTIC ANEURYSM MEASURING 65 MM WITH A CONTAINED AORTIC RUPTURE. THE LEFT ILIAC LIMB (ETLW1624C124E) HAD PULLED UP INTO THE ABDOMINAL AORTIC ANEURYSM SAC WITH AN ASSOCIATED TYPE IB ENDOLEAK. A 24MM LIMB WAS IMPLANTED O THE LEFT LIMB, AND THE EVENT WAS REPORTED AS RESOLVED. THERE WAS NO ENDOLEK ON THE RIGHT LIMB BUT THE PHYSICIAN DECIDED TO EXTEND THE DISTAL SEAL USING A 20MM LIMB. PER THE PHYSICIAN THE CAUSE WAS ANATOMY AND DISEASE PROGRESSION, WHICH WAS DESCRIBED AS A SHORT, DILATED, TORTUOUS ILIAC. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY POST INTERVENTION.

  Patient problems: Pain; Rupture

  MAUDE report 25485196 ↗
• InjuryFeb 9, 2026Leak/Splash

  IT WAS REPORTED THAT FOLLOWING A PRIOR ENDOVASCULAR AORTIC REPAIR WITH THE STENT GRAFT ETLW1624C124E ENDUR II LIMB, SAC GROWTH (ANEURYSM SAC ENLARGEMENT) WAS DETECTED ON ULTRASOUND DURING A FOLLOW-UP VISIT APPROXIMATELY 7 YEARS AND 7 MONTHS LATER. ANGIOGRAPHY REVEALED A TYPE 1B ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY, WITH THE ANEURYSM MEASURING 62 MM. AN ADDITIONAL ILIAC LIMB EXTENSION OF THE SAME MODEL WAS PLACED IN THE RIGHT COMMON ILIAC ARTERY TO REPAIR THE ENDOLEAK, AND THE EVENT WAS RESOLVED. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK WAS ATTRIBUTED TO DISEASE PROGRESSION. NO ADDITIONAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Aneurysm expansion

  MAUDE report 24290873 ↗
• InjuryJan 21, 2026Leak/Splash

  IT WAS REPORTED THAT AN ETLW1624C124E WAS USED DURING AN INITIAL REPAIR OF A 66 MM ABDOMINAL AORTIC ANEURYSM. A TYPE IB ENDOLEAK WAS IDENTIFIED ON IMAGING ALMOST TEN YEARS POST IMPLANT. THE CAUSE WAS ATTRIBUTED TO ANATOMY AND RIGHT COMMON ILIAC DILATATION. FUTURE TREATMENT IS PLANNED TO EXTEND THE GRAFT LIMB. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 24128887 ↗
• MalfunctionSep 8, 2025Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT SCAN TAKEN APPROXIMATELY 4 YEARS POST-INDEX PROCEDURE REVEALED DISEASE PROGRESSION ON THE RIGHT LIMB. THIS WAS REPORTED AS VESSEL DISEASE PROGRESSION AND GROWTH AROUND THE DISTAL END OF THE LIMB, WITHOUT AFFECTING THE ANEURYSM SAC. APPROXIMATELY 5 YEARS AND 3 MONTHS AFTER THE INDEX PROCEDURE, A FOLLOW-UP CT SCAN IDENTIFIED A COMBINATION OF A TYPE II ENDOLEAK FROM LUMBAR ARTERIES AND OTHER VESSELS, AS WELL AS A POSSIBLE TYPE IB ENDOLEAK FROM THE RIGHT LIMB STENT GRAFT (B)(6). IT REMAINS UNCLEAR WHETHER THERE IS A TYPE IB ENDOLEAK OR IF THE FINDINGS ARE SOLELY DUE TO DISEASE PROGRESSION. PER THE PHYSICIAN, THE CAUSE OF THE POSSIBLE TYPE IB ENDOLEAK IS UNDETERMINED, HOWEVER, IT IS BELIEVED THAT DISEASE PROGRESSION IN THE LIMB MAY HAVE CONTRIBUTED TO ITS DEVELOPMENT. NO VESSEL TORTUOSITY, CALCIFICATION OR THROMBUS WAS OBSERVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22990664 ↗
• InjuryJun 20, 2025Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ENDURANT II STENT GRAFT WAS USED TO TREAT A 52 MM ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, AFTER COMPLETE DEPLOYMENT OF THE BIFURCATED DEVICE VIA THE RIGHT LEG, CANNULATION OF THE CONTRALATERAL GATE WAS ATTEMPTED FROM THE LEFT GROIN ACCESS. THE IPSILATERAL LIMB OF THE DEVICE WAS ACCIDENTALLY CANNULATED INSTEAD OF THE CONTRALATERAL LIMB, AND THIS ERROR WENT UNNOTICED INITIALLY. THE CONTRALATERAL LIMB TO THE LEFT LEG WAS THEN DEPLOYED INSIDE THE IPSILATERAL LIMB OF THE MAIN DEVICE, LEAVING THE CONTRALATERAL GATE OF THE MAIN DEVICE UN-CANNULATED. BOTH LIMBS WERE ULTIMATELY DEPLOYED INSIDE THE IPSILATERAL LIMB OF THE MAIN DEVICE, WITH NOTHING ON THE CONTRALATERAL SIDE. DURING THE FINAL DIAGNOSTIC RUN, SLOW FILLING ON THE LEFT SIDE AND A LARGE ENDOLEAK FILLING THE SAC WERE OBSERVED. IT WAS SUSPECTED THAT A CLOT INSIDE THE GRAFT WAS IMPEDING FLOW DOWN THE LEFT LEG, SO A VENOUS STENT WAS INSERTED BILATERALLY INSIDE THE LIMBS, WHICH IMPROVED FLOW. THE CAUSE OF THE INACCURATE DELIVERY WAS ATTRIBUTED TO USER ERROR. THE EVENT WAS RESOLVED ENDOVASCULARLY AT A DIFFERENCE HEALTHCARE FACILITY. A 16X24X124 MM LIMB WAS PLACED INTO THE LEFT LIMB AND UP TO THE FLOW DI

  Patient problems: Obstruction/Occlusion

  MAUDE report 22296207 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY DUE TO A TYPE IA ENDOLEAK APPROXIMATELY 4.5 YEARS SINCE IMPLANTATION OF AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM. THE TREATMENT INVOLVED AN OPEN SURGICAL CONVERSION, DURING WHICH THE PRODUCT WAS EXPLANTED. IT WAS NOTED THERE WERE NO ISSUES WITH THE LIMB STENT GRAFTS. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS UNDERSIZING. THE EVENT WAS RESOLVED THROUGH THIS OPEN SURGICAL CONVERSION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21685948 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 3 WEEKS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY EXPERIENCING RIGHT LEG PAIN ALONG WITH A COLD LEG. CT IMAGING REVEALED THAT THE RIGHT ILIAC LIMB WAS COMPLETELY THROMBOSED. THE PHYSICIAN REVIEWED THE CT AND COULD NOT DETERMINE A GRAFT COMPLICATION AND SUSPECTED THE PATIENT HAD A CLOT EMBOLIZE INTO THE GRAFT FROM A HEART CONDITION. INTERVENTION WAS PERFORMED. A NON MDT CATHETER WAS USED TO DE-CLOT THE RIGHT ILIAC LIMB WHICH WAS THEN RE-LINED WITH 16-16/156 GRAFT RESTORING BLOOD FLOW. PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION IS UNKNOWN BUT THE PHYSICIAN SUSPECTED THE PATIENT HAD A CLOT EMBOLIZE INTO THE GRAFT FROM HEART CONDITION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Limb Pain; Obstruction/Occlusion

  MAUDE report 19070559 ↗
• MalfunctionApr 21, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED AAA. IT WAS REPORTED APPROXIMATELY 6 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY TO THE ER. A CT SHOWED LOSS OF APPOSITION OF THE PROXIMAL AND DISTAL STENT GRAFTS AND THE PATIENT NOW HAS A THORACOABDOMINAL ANEURYSM. IT WAS NOTED THAT THE PATIENT HAS NOT FOLLOWED UP WITH PHYSICIAN SINCE THE INDEX PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE LOSS OF APPOSITION IS DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16784316 ↗
• InjuryJan 11, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A RUPTURED AAA ON (B)(6) 2021.  IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW-UP, ON (B)(6) 2022, THE PATIENT WAS COMPLAINING OF CLAUDICATION. A CTA AND ANGIOGRAPHY WAS PERFORMED WHICH SHOWED THE CONTRALATERAL LIMB WAS COMPLETELY THROMBOSED. A THROMBECTOMY WAS THEN PERFORMED. THE PHYSICIAN HAS NOT DETERMINED A ROOT CAUSE FOR THE OCCLUSION. IT WAS CONFIRMED THE LIMBS WITH SN: (B)(4) WERE ON THE CONTRALATERAL SIDE. DURING THE INITIAL PROCEDURE, PROPER DISTAL SEAL WAS NOT ACHIEVED AND EXTENSIONS NEEDED TO BE PLACED INSIDE THE FLARED LIMB, WITH A FLARED LIMB. THESE LIMBS NOTED ARE THOSE THAT WERE PLACED ON THE CONTRA SIDE-WHICH IS THE SIDE WHERE OCCLUSION WAS REPORTED. IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE ON (B)(6) 2021, AN ETLW1624C124E WAS PLACED ON THE CONTRA AND IPSILATERAL LIMB. UNFOR TUNATELY NEITHER OF THESE LIMBS ACHIEVED DISTAL SEAL. THEREFORE AN ETLW1614C93E LIMB WAS PLACED AS AN EXTENSION ADDITIONALLY ON EACH SIDE. AT THE END OF THE PROCEDURE DISTAL SEAL WAS ACCOMPLISHED ON BOTH THE CONTRALATERAL AND IPSILATERAL LIMBS. IT WAS CONFIRMED ONLY THE 2 LIMBS ON THE CONTRALATER

  Patient problems: Insufficient Information; Obstruction/Occlusion; Pain

  MAUDE report 16136495 ↗
• InjuryDec 12, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A RUPTURED AAA .  IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW-UP, THE PATIENT WAS COMPLAINING OF CLAUDICATION. A CTA AND ANGIOGRAPHY WAS PERFORMED WHICH SHOWED THE CONTRALATERAL LIMB WAS COMPLETELY THROMBOSED. A THROMBECTOMY WAS THEN PERFORMED. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED. THE PATIENT STILL REPORTS SOME RESIDUAL CLAUDICATION.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 15958316 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II LIMB WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED 5 DAYS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH PAIN IN THE RIGHT LEG. IT WAS FOUND THAT THE RIGHT LIMB THROMBOSED THE ENTIRE WAY FROM THE FLOW DIVIDER TO THE DISTAL LIMB. THE RIGHT HYPO WAS ALSO THROMBOSED. IT WAS DIFFICULT TO CROSS WITH A GUIDEWIRE SO THE PHYSICIAN PERFORMED A FEM FEM BYPASS. PER THE PHYSICIAN, THE CAUSE OF THE THROMBOSIS WAS DUE TO OVERSIZING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information; Pain; Thrombosis/Thrombus

  MAUDE report 14216700 ↗
• InjuryApr 4, 2022Leak/Splash; Migration or Expulsion of Device; Activation, Positioning or Separation Problem; Leak/Splash; Migration or Expulsion of Device; Activation, Positioning or Separation Problem

  AN ENDURANT II LIMB STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON AN UNKNOWN DATE FOLLOW UP SCAN, IT WAS IDENTIFIED THAT THE LEFT COMMON ILIAC STENT HAD MIGRATED PROXIMALLY LOSING APPOSITION WITH THE ILIAC WALL RESULTING IN A TYPE IB ENDOLEAK. APPROXIMATELY 9 MONTHS POST THE INDEX PROCEDURE AN ETLW1624C124E WAS IMPLANTED INTO THE LEFT COMMON ILIAC ARTERY. AFTER ANGIOGRAM IT WAS NOTED THAT THE ENDOLEAK WAS RESOLVED AND THE CASE WAS CONCLUDED. PER PHYSICIAN, THE MIGRATION WAS CAUSED BY INITIAL AORTIC REMODELING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13994630 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ENDURANT II STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED FROM A CT FROM AN UNKNOWN DATE THAT THE LEFT COMMON ILIAC ARTERY HAS DILATED TO APPROXIMATELY 25MM AND THE RIGHT COMMON ILIAC ARTERY HAS  DILATED TO APPROXIMATELY 36 MM DISTAL TO THE EXISTING STENT GRAFT LIMB. IT APPEARS THAT THE EXISTING GRAFTS ARE IN PLACE WITH NO ISSUES INVOLVING THE GRAPHS. A SECONDARY PROCEDURE WAS PERFORMED . INITIALLY IMAGING WAS INTERROGATED AND BOTH PROXIMAL AND BILATERAL DISTAL SEALS ZONES WERE AN ALYZED. PROXIMALLY THE STENT GRAFT LOOKED GOOD WITH NO TYPE IA ENDOLEAK. .AS EXPECTED THE LEFT COMMON ILIAC STENT EXISTS APPROXIMATELY 1 CM ABOVE THE HYPOGASTRIC ON THAT SIDE. THE SEAL ON THE LEFT SIDE WAS FOUND TO HAVE NO PROBLEM AND NO REASON TO EXTEND OR TREAT THE LEFT LIMB AS WHAT WAS PREVIOUSLY ANTICIPATED. DUE TO THE DILATED SEGMENT OF THE DISTAL COMMON ILIAC ARTERY ON THE RIGHT SIDE THE PHYSICIAN DECIDED TO COIL THE RIGHT HYPOGASTRIC ARTERY AND IMPLANT A PLUG. AN EXTENSION LIMB WAS PLACED IN THE EXISTING GRAFT ON THE RIGHT SIDE AND CREATED A SEAL ACROSS THE RIGHT TYPE OF GASTRIC AND INTO THE RIGHT EXTERNAL ILIAC

  Patient problems: Aneurysm

  MAUDE report 13692393 ↗
• InjuryDec 7, 2021Malposition of Device; Malposition of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN 80MM ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED DURING A CT PERFORMED ON 5 DAYS LATER , THAT THE PHYSICIAN NOTED THE LIMB ETLW1624C124E WAS ONLY 1-2CM INTO THE COMMON ILIAC ARTERY AND IT WAS MENTIONED THAT THE PHYSICIAN HAD 2CM TO THE INTERNAL ILIAC ARTERY .THE PHYSICIAN DECIDED TO EXTEND THE GRAFT 2CM INTO THE COMMON ILIAC ARTERY AND THE EVENT WAS RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF EVENT WAS DUE TO USER ERROR.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12950988 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 72MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY OVER A YEAR LATER, WITH ABDOMINAL PAIN. A CT PERFORMED SHOWED A TYPE IA ENDOLEAK AND ANEURYSM EXPANSION. INTERVENTION WAS PERFORMED ON THE SAME DATE, ALL STENT GRAFTS WERE EXPLANTED VIA OPEN REPAIR. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; Pain

  MAUDE report 10441512 ↗
• DeathJul 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 55+ MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AT THE END OF THE INDEX PROCEDURE, DURING BALLOONING OF THE STENT GRAFT THE DISTAL OR THE PROXIMAL RIGHT ILIAC ARTERY WAS RUPTURED. IT WAS REPORTED THAT THE PHYSICIAN QUICKLY IMPLANTED A ETLW1616C124E LIMB FROM INSIDE THE PREVIOUSLY IMPLANTED ETLW1624C124E, ACROSS THE INTERNAL ILIAC AND INTO THE RIGHT EXTERNAL ARTERY, WHERE THE PHYSICIAN BELIEVED TO BE THE DISRUPTION. ANOTHER ANGIOGRAM WAS PERFORMED AND SOME RUPTURE WAS STILL NOTED. THE PHYSICIAN THEN DECIDED TO IMPLANT A ETLW1620C156E IT THE HIGHER AND LOWER END ON THE PREVIOUSLY IMPLANTED STENT GRAFT. FINAL ANGIOGRAM WAS PERFORMED WITH NO ADDITIONAL EVIDENCE OF RUPTURED ARTERY. AS PER THE PHYSICIAN, CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Death; Perforation of Vessels

  MAUDE report 10319401 ↗
• InjuryJun 10, 2020Malposition of Device; Malposition of Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN A 53MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY NINE DAYS LATER WITH A COLD LEFT FOOT AND LEG PAIN. CT SHOWED THAT THE LEFT STENT GRAFT LIMB WAS THROMBOSED. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE STENT GRAFT LIMB WAS UNINTENTIONALLY DEPLOYED INTO THE EXTERNAL ILIAC ARTERY COVERING THE LEFT HYPOGASTRIC. A THROMBECTOMY WAS CARRIED OUT OF THE LEFT ILIAC LIMB EIGHT DAYS LATER. SOME CLOT WAS REMOVED BUT SOME REMAINED IN THE GATE AREA OF THE GRAFT. A FEM-FEM BYPASS WAS CARRIED OUT SO BLOOD FLOW WAS RESTORED TO THE LEFT LEG. IT WAS REPORTED THERE WAS SOME BLOOD FLOW THROUGH THE GRAFT, BUT THE PHYSICIAN WAS NOT CONFIDENT IT WOULDN¿T CLOT AGAIN DUE TO NARROWING AT THE EXTERNAL ILIAC ARTERY. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY. IT WAS REPORTED BY THE PHYSICIAN, THE THROMBOSIS WAS CAUSED BECAUSE THERE WAS NO FLOW INTO THE LEFT HYPOGASTRIC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion; Pain; Thrombus

  MAUDE report 10137312 ↗
• InjuryMay 28, 2020Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCAULAR TREATMENT OF AN 110MM RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT LATER THAT EVENING THE PATIENT PRESENTED EMERGENTLY WITH A RE-RUPTURED ANEURYSM AND HAD A DROP IN BLOOD PRESSURE AS A RESULT. INTERVENTION WAS PERFORMED AND A AUI DEVICE WAS IMPLANTED AND A FEM/FEM BYPASS WAS PERFORMED AND THE EVENT WAS REPORTED TO BE RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS LIMB OVERLAP. IT WAS CONFIRMED THE SEPARATION OCCURRED BETWEEN THE STENT GRAFT LIMBS ETLW1624C124 AND ETLW1615C93 AND THE BIFURCATED STENT GRAFT WAS NOT INVOLVED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 10095121 ↗
• InjuryJan 16, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT LIMB WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 98MM ABDOMINAL AORTIC ANEURYSM. IT IS REPORTED THAT DURING THE INDEX PROCEDURE A TYPE III ENDOLEAK WAS OBSERVED. THIS ENDOLEAK WAS THEN RESOLVED BY RELINING THE STENT GRAFT LIMB ETLW1624C124E WITH ANOTHER ENDURANT LIMB ETLW1616C93E. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS DUE TO PATIENT ANATOMY, WHICH WAS REPORTED TO BE TORTUOUS. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9595123 ↗
• InjuryOct 1, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT THE PATIENT HAD BEEN IN THE HOSPITAL SINCE THE IMPLANT OF THE STENT GRAFT SYSTEM, THREE DAYS PREVIOUSLY. AN OPEN REPAIR WAS CARRIED OUT TO CLEAN OUT THE PATIENT'S ABDOMEN AND IT WAS NOTED THAT THE AAA SAC WAS PULSATILE. AN ANGIOGRAM WAS THEN CARRIED OUT, WHICH SHOWED A TYPE IB ENDOLEAK FROM THE RIGHT COMMON ILIAC. ON THE SAME DAY, THE PHYSICIAN IMPLANTED AN ADDITIONAL ENDURANT LIMB IN THE RIGHT COMMON ILIAC, AS TREATMENT AND THE ENDOLEAK WAS RESOLVED. AS PER THE PHYSICIAN, THE TYPE 1B WAS POSSIBLY CREATED FROM THE MANIPULATION BY THE GENERAL SURGEONS IN THE ABDOMEN WHEN THEY WERE DOING A BOWEL REPAIR AND CLEANING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9138828 ↗
• InjuryAug 27, 2019Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY TWO YEARS AND NINE MONTHS LATER WITH A TYPE IB ENDOLEAK AND ANEURYSM EXPANSION. A SECONDARY PROCEDURE WAS CARRIED OUT AND THE STENT GRAFT LIMBS EXTENDED BILATERALLY INTO THE EXTERNAL ILIAC ARTERIES TO RESOLVE THE TYPE IB ENDOLEAKS. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT¿S ANATOMY. THERE WAS INADEQUATE SEAL IN THE COMMON ILIAC ARTERIES CAUSING THE TYPE IB ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8934316 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH AN ISCHEMIC RIGHT LEG APPROXIMATELY THREE WEEKS LATER. THE PATIENT REPORTED THAT THEY HAD BEEN LIKE THAT FOR THREE DAYS. A CT SCAN SHOWED THE RIGHT STENT GRAFT LIMB WAS OCCLUDED UP TO THE FLOW DIVIDER WITH A NARROWING JUST DISTAL TO THE AORTIC BIFURCATION. A SECONDARY PROCEDURE WAS CARRIED OUT THE DAY AFTER THE PATIENT PRESENTED EMERGENTLY. IT WAS ATTEMPTED TO REMOVE THE CLOT FROM THE LIMB AND AN ADDITIONAL STENT GRAFT LIMB ETLW1610C124E WAS IMPLANTED TO EXTEND INTO THE EXTERNAL ILIAC ARTERY. IT WAS REPORTED THAT ADEQUATE FLOW COULD NOT BE ACHIEVED THROUGH THE LIMB AND SO A FEM-FEM BYPASS WAS THEN CARRIED OUT TO RESOLVE THE EVENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS DUE TO PATIENT ANATOMY. IT WAS REPORTED THAT AT THE INDEX PROCEDURE STENOSIS AND TORTUOSITY WAS NOTED AT THE PROXIMAL RIGHT COMMON ILIAC ARTERY WHICH HINDERED PRECLOSURE. PRECLOSURE WAS COMPLETED AFTER MUCH DIFFICULTY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 8699514 ↗
• InjuryMar 12, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED THE LCIA HAS DILATED BEYOND 24MM RESULTING IN LOSS OF SEAL AND A TYPE IB ENDOLEAK. INTERVENTION WAS COMPLETED. THE PHYSICIAN PERFORMED COIL EMBOLIZATION OF LIIA AND PLACED AN EXTENSION (16/10/156) INTO THE PROXIMAL LEIA AND THE ENDOLEAK WAS CONFIRMED AS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO A CHANGE IN THE PATIENT'S ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8412665 ↗
• InjuryFeb 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 54MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW UP APPROXIMATELY 5 WEEKS POST IMPLANT, THE PATIENT'S LEFT LIMB WAS OCCLUDE D. NO ISSUE WITH THE STENT GRAFT WAS NOTED ON CTA. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Occlusion

  MAUDE report 8370759 ↗
• DeathSep 5, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT APPROX. 2 YEARS, 9 MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN. A CT SCAN IDENTIFIED A TYPE IB ENDOLEAK IN THE LEFT DISTAL COMMON ILIAC WITH RUPTURE OF THE ARTERY. THE PATIENT RECEIVED TREATMENT WITH THE PLACEMENT OF COILS IN THE LEFT HYPOGASTRIC AND IMPLANTATION OF AN ENDURANT LIMB IN THE LEFT COMMON ILIAC EXTENDING INTO THE LEFT EXTERNAL ILIAC AND THE ISSUE WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS DUE TO DISEASE PROGRESSION WITHIN THE PATIENT. IT WAS REPORTED THAT 2 DAYS POST INTERVENTION, THE PATIENT HAD HEMATOCHEZIA. PART OF THE DESCENDING AND SIGMOID COLON WAS REMOVED, IT WAS REPORTED THAT THE PROCEDURE WAS TOLERATED WELL BY THE PATIENT WHO WAS THEN MOVED TO ICU WHERE THEY WERE AMBULATORY POST SURGERY. ONE WEEK POST OP THE PATIENT COMPLAINED OF SHOULDER PAIN AND SHORTNESS OF BREATH. THE FAMILY DECIDED ON NO FURTHER TREATMENT AND THE PATIENT EXPIRED THE FOLLOWING DAY DUE TO RESPIRATORY ARREST. AS PER THE PHYSICIAN, THE CAUSE OF THE SUBSEQUENT EVENTS AFTER THE INTERVENT

  Patient problems: Blood Loss; Death; Ischemia; Respiratory Failure; Rupture

  MAUDE report 7846650 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100021. One submission often covers many models, so check the product and lot details in each record.

• Z-0292-2022 · Oct 15, 2021 · Open, Classified
  Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STEN
• Z-0291-2022 · Oct 15, 2021 · Open, Classified
  Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT G
• Z-0290-2022 · Oct 15, 2021 · Open, Classified
  Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
• Z-2136-2021 · Jun 7, 2021 · Open, Classified
  Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoili
• Z-2135-2021 · Jun 7, 2021 · Open, Classified
  Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infra
• Z-1543-2017 · Feb 27, 2017 · Terminated
  Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166