Endurant® II ETLW1624C156E (UDI 00643169467491)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169467491), received between Mar 17, 2017 and May 22, 2023 — classified as 1 death, 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2023Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA.  IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP OVER SIX YEARS LATER, A CT PERFORMED IDENTIFIED THE RIGHT ILIAC LIMB HAD RETRACTED FROM THE RIGHT COMMON ILIAC ARTERY INTO THE ANEURYSM SAC CAUSING A TYPE IB ENDOLEAK. THE RIGHT COMMON ILIAC DIAMETER IS NOW 28MM. THE PATIENT IS ASYMPTOMATIC.  PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 16972457 ↗
• MalfunctionFeb 15, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A >70MM AAA . IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP, A TYPE IA AND IB ENDOLEAK WERE OBSERVED ON CT. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16377614 ↗
• InjuryDec 2, 2021Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 100MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM 4 DAYS LATER WITH GROIN PAIN. A CT WAS CARRIED OUT WHICH SHOWED THAT BOTH LIMBS ETLW1624C156E AND ETLW1616C156E HAD MIGRATED. THE LIMB IN THE RIGHT COMMON ILIAC ARTERY HAD MIGRATED ABOVE THE BIFURCATION. THE LIMB ON THE RIGHT WAS APPROXIMATELY 1CM INTO THE COMMON ILIAC ARTERY. AN INTERVENTION WAS PERFORMED AND THE LIMBS WERE EXTENDED AND LANDED AT BOTH INTERNAL ILIAC ARTERIES. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 12916102 ↗
• InjuryJul 14, 2021Obstruction of Flow; Obstruction of Flow

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 69 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED A CT WAS PERFORMED APPROXIMATELY 19 MONTHS POST PROCEDURE , WHERE IT WAS NOTED THAT THE PATIENT THROMBOSED THE RIGHT COMMON ILIAC ARTERY LIMB FROM THE LEVEL OF THE FLOW DIVIDER TO THE RIGHT COMMON FEMORAL ARTERY. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PATIENT'S ANATOMY, DUE TO WHAT APPEARS TO BE AN ACUTE BEND AT THE DISTAL AORTA GOING INTO THE PROXIMAL RCIA WHICH CAUSED THE LIMB TO BE PINCHED NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12166348 ↗
• InjuryFeb 24, 2021Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PRE-RUPTURED 65MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 38 MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH A TYPE 3ENDOLEAK ON THE ETLW1624C156E LIMB AND A TYPE 1B ENDOLEAK ON THE ETLW1620C124E. ETLW1624C124E WAS IMPLANTED TO TREAT THE EVENT AND EMBOLIZED THE INTERNAL ILIAC ARTERY AND BUILT DOWN TO THE EXTERNAL WITH A ETLW1610C156E LIMB. ENDOLEAKS WERE RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS A TYPE 3 HOLE IN THE LIMB. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11372710 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR TREATMENT. IT WAS REPORTED THAT AN ANGIOGRAM PERFORMED OVER THREE YEARS LATER, SHOWED THAT THE LEFT LIMB ETLW1624C156E HAD A SLIGHT NARROWING IN THE PROXIMAL PORTION AND MODERATE TO SEVERE THROMBUS THROUGHOUT THE ENTIRE LEFT LIMB. INTERVENTION WAS PERFORMED ON THE SAME DATE, THE ENTIRE LIMB WAS RELINED DOWN TO THE HYPOGASTRIC ARTERY ON THE LEFT SIDE. THIS RESOLVED THE EVENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion; Occlusion

  MAUDE report 10717761 ↗
• InjuryDec 19, 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 70MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN BALLOONED DISTALLY AND THE DISTAL RIGHT CIA RUPTURED. THE PHYSICIAN PERFORMED INTERVENTION WITH THE IMPLANTATION OF ANOTHER ENDURANT LIMB TO EXTEND INTO THE RIGHT EIA TO RESOLVE THE EVENT. THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 9493894 ↗
• InjuryAug 3, 2018Leak/Splash; Migration or Expulsion of Device; Obstruction of Flow; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 91MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A FOLLOW UP CT SCAN APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE A TYPE IB ENDOLEAK WAS NOTED WITH ANEURYSMAL SAC ENLARGEMENT. THE PATIENT RECEIVED INTERVENTION; THE RIIA AND FEEDER VESSELS WERE OCCLUDED USING COILS AND PLUGS. AN ENDURANT LIMB WAS PLACED AT THE LEVEL OF THE FLOW DIVIDER AND EXTENDED DOWN IN TO THE REIA AND ANOTHER ENDURANT LIMB WAS USED TO EXTEND FURTHER DOWN THE REIA. THIS RESOLVED THE EVENT. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE PATIENTS¿ ANATOMY, WITH A CONTINUED DILATION OF THE RCIA CAUSING THE LIMB TO HAVE LOSS OF SEAL AND TO HAVE PULLED UP INTO THE SAC CAUSING A TYPE IB ENDOLEAK NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Injury; No Code Available

  MAUDE report 7747014 ↗
• InjuryApr 16, 2018Leak/Splash; Leak/Splash

  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 A TYPE IB ENDOLEAK WAS IDENTIFIED ON A CT EXAM PERFORMED APPROXIMATELY 3 YEARS POST INDEX PROCEDURE. THE PATIENT'S ILIAC ARTERY DISTAL TO THE STENT GRAFT RANGED IN DIAMETER FROM 27.3MM-29.4MM. INTERVENTION WAS CARRIED OUT TO RESOLVE THE LEAK DURING WHICH, THE LEFT HYPOGASTRIC ARTERY WAS PLUGGED AND A 16X20X199 LIMB EXTENSION WAS IMPLANTED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO FURTHER ILIAC ARTERY DILATION NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7432010 ↗
• InjuryMar 6, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN ENDOVASCULAR TREATMENT. IT WAS REPORTED AFTER THE INDEX PROCEDURE, THE PATIENT PHONED TECHNICAL SERVICES TO REPORT THAT THEY HAVE EXPERIENCED A METALLIC TASTE IN THEIR MOUTH AND A LOSS OF APPETITE. THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED.

  Patient problems: Reaction

  MAUDE report 7317535 ↗
• InjuryAug 10, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT, APPROXIMATELY TWO YEARS AND THREE MONTHS POST INDEX PROCEDURE, A CT REVEALED THAT THE ENDURANT II STENT GRAFT LIMB HAD A DISTAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT STENT GRAFT LIMB [28X28X82] AND SIX HELI-FX ENDOANCHORS. THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6783856 ↗
• DeathMar 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 62 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT, DURING THE INDEX PROCEDURE, AN ANGIOGRAM REVEALED THAT THE ENDURANT IIS STENT GRAFT BIFURCATE HAD A PROXIMAL TYPE I ENDOLEAK. IT WAS DETERMINED THAT THE ENDURANT IIS STENT GRAFT BIFURCATE HAD BEEN ACCURATELY IMPLANTED DISTAL TO THE RENAL ARTERY. THE PHYSICIAN MODELED THE PROXIMAL END OF THE STENT GRAFT BIFURCATE WITH A BALLOON. HOWEVER, AFTER REPEATED BALLOONING, THE PROXIMAL TYPE I ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN THEN ELECTED TO IMPLANT SEVEN APTUS ENDOANCHORS SINCE THERE WAS INSUFFICIENT SPACE BETWEEN THE RENAL ARTERIES AND THE FLOW DIVIDER TO PLACE AN AORTIC CUFF. HOWEVER, THE PROXIMAL TYPE I ENDOLEAK DID NOT IMPROVE AFTER THE APTUS ENDOANCHORS HAD BEEN IMPLANTED. DUE TO THE AMOUNT CONTRAST USED, THE PHYSICIAN ELECTED TO COMPLETE THE PROCEDURE. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WAS RELEASED FROM THE HOSPITAL AND IT WAS LATER REPORTED THAT THE PATIENT EXPIRED IN A NURSING HOME. THE PHYSICIAN STATED THAT THE PATIENT CAUSE OF DEATH WAS UNKNOWN AND AN AUTOPSY WAS RE FUSED. NO AD

  Patient problems: Death

  MAUDE report 6415210 ↗

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-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-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-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