Endurant® II ETLW1620C156E (UDI 00613994991652)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994991652), received between Jun 27, 2017 and Sep 9, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Leak/Splash” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2020Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY JUST UNDER SEVEN YEARS LATER, WITH COMPLAINTS OF ABDOMINAL PAIN. A CTA WAS PERFORMED AND IT SHOWED THE LIMB ETLW1620C156E THAT HAD BEEN IMPLANTED IN THE LEFT COMMON ILIAC ARTERY HAD PULLED UP INTO THE ANEURYSM SAC CAUSING A IB ENDOLEAK. INTERVENTION WAS PERFORMED ON THE SAME DATE, THE LEFT HYPOGASTRIC ARTERY WAS EMBOLIZED WITH COILS AND A 16/16/124 ENDURANT LIMB WAS IMPLANTED FROM THE FLOW DIVIDER FOLLOWED BY ANOTHER ENDURANT LIMB 16/13/156 WHICH WAS IMPLANTED TO EXTEND TO THE LEFT EXTERNAL ILIAC ARTERY. IT WAS NOTED THE LEFT COMMON ILIAC ARTERY WAS MEASURING OVER 30MM. THE GRAFTS WERE BALLOONED AND A FINAL ANGIOGRAM SHOWED THE ENDOLEAK HAD RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY AND DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 10506841 ↗
• InjuryMay 1, 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 DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY THREE YEARS LATER THE PATIENT PRESENTED EMERGENTLY. A TYPE IB ENDOLEAK WAS NOTED, WITH MIGRATION OF THE LEFT ILIAC LIMB FROM ITS INITIAL DEPLOYMENT SITE AT THE LCIA. THE PHYSICIAN SUCCESSFULLY TREATED THE PATIENT BY IMPLANTING AN ENDURANT LIMB EXTENSION (SIZE 1624156) ON THE SAME DAY. THE PHYSICIAN STATED THE CAUSE OF THE EVENT WAS ANATOMY RELATED. THE ILIAC APPEARED TO DILATE AND THE LIMB PULLED OUT OF THE ILIAC INTO THE AAA. THE CAUSE OF THE DILATION COULDN'T BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8568217 ↗
• InjuryNov 10, 2017Leak/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 THE PATIENT FOR FOLLOW UP CT, ON WHICH A TYPE IB ENDOLEAK ORIGINATING FROM THE LEFT COMMON ILIAC ARTERY WAS OBSERVED BY THE PHYSICIAN. THIS ENDOLEAK WAS CONFIRMED ON ANGIOGRAM. INTERVENTION WAS PERFORMED TO RESOLVE THE EVENT BY USING COILS TO EMBOLIZE THE LEFT HYPOGASTRIC ARTERY AND AN ENDURANT LIMB WAS USED TO BUILD ONTO THE LEFT EXTERNAL ILIAC. FINAL ANGIOGRAM SHOWED THAT THIS PROCEDURE RESOLVED THE TYPE IB ENDOLEAK ON THE LEFT SIDE BUT THERE WAS NOW OBSERVED A LEAK ON THE RIGHT SIDE. THE PHYSICIAN DECIDED TO STOP THE PROCEDURE AT THIS STAGE AND DISCUSS NEXT STEPS WITH THE PATIENT BECAUSE AS THEY DIDN'T WANT TO EMBOLIZE BOTH HYPO GASTRIC ARTERIES IN THE SAME SURGERY. THE TYPE IB ENDOLEAK REMAINS ON THE RIGHT SIDE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS ANATOMY RELATED DUE TO DISEASE PROGRESSION IN BOTH COMMON ILIAC ARTERIES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7016868 ↗
• InjuryJun 27, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS SELECTED FOR USE IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH BACK AND ABDOMINAL PAIN. THE CT REVEALED THAT THERE WAS A TYPE III SEPARATION ENDOLEAK BETWEEN THE ENDURANT BIFURCATED STENT GRAFT AND THE ENDURANT 16X13X124. CURRENTLY THE ABDOMINAL AORTIC ANEURYSM IS 7.3 CM IN DIAMETER AND 9.3 CM IN LENGTH. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT 16X16X156 ILIAC LIMB. THE FINAL ANGIOGRAM DEMONSTRATED THAT THE TYPE III SEPARATION ENDOLEAK WAS RESOLVED. TWO DAYS LATER THE FOLLOW UP CT REVEALED THAT THERE WAS AN UNKNOWN ENDOLEAK IN THE AREA OF THE JUNCTION OF THE BIFURCATED STENT GRAFT AND THE ENDURANT 16X20X156 ILIAC LIMB ON THE OTHER SIDE. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT 16X20X124 ILIAC LIMB. THE UNKNOWN ENDOLEAK WAS RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF BOTH, THE TYPE III SEPARATION ENDOLEAK AND THE UNKNOWN ENDOLEAK WERE RELATED TO THE PATIENT¿S ANATOMY; DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 6671756 ↗

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-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-0290-2022 · Oct 15, 2021 · Open, Classified
  Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
• 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-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-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