Endurant® II ETEW2424C82ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994991409), received between Oct 19, 2017 and Sep 18, 2023 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE SHOWED A TYPE III ENDOLEAK IN ETEW2424C82E. INTERVENTION WAS PERFORMED ON THE (B)(6) 2023 AND ETEW2828C82E AND ETLW1628C146E WERE IMPLANTED TO TREAT THE ENDOLEAK. NO CAUSE WAS PROVIDED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17763465 ↗
• MalfunctionOct 27, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.2 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE FINAL ANGIOGRAM REVEALED A TYPE 1B ENDOLEAK FROM THE ENDURANT II-LIMB CONTRA 16X20X124 STENT GRAFT THAT WAS IMPLANTED INTO THE LEFT COMMON ILIAC ARTERY. IMPLANTED A 24X24X82 LIMB EXTENSION AND THE TYPE IB ENDOLEAK IMPROVED, HOWEVER THE ENDOLEAK PERSISTED. THE PHYSICIAN DETERMINED THAT THERE WAS ALSO A TYPE IA ENDOLEAK. THE PHYSICIAN MODELED THE PROXIMAL AORTIC NECK WITH A BALLOON AGAIN BUT THE PROXIMAL TYPE IA ENDOLEAK WAS STILL PRESENT. IT WAS REPORTED THAT THE BIFURCATED STENT GRAFT WAS IMPLANTED 1 CM (BELOW THE RENAL ARTERY OR LOWER THAN INTENDED) THEREFORE THERE WAS ROOM TO IMPLANT A ENDURANT 28X28X49 AORTIC CUFF. THE TYPE IA ENDOLEAK WAS SIGNIFICANTLY IMPROVED BUT THERE WAS STILL A PERSISTENT LATE SMALL TYPE IA ENDOLEAK. THE PHYSICIAN MODELED THE ENDURANT 16X24X124 IPSI-LATERAL EXTENSION LIMB ON THE RIGHT SIDE WITH A BALLOON. THERE WERE STILL ENDOLEAKS PRESENT HOWEVER, THE PHYSICIAN DECIDED THAT IT WAS BEST FOR THE PATIENT DO NOTHING FURTHER AND FOLLOW UP WITH A CT SCAN IN APPROXIMATELY ONE MONTH. PER THE PHYSIC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6982847 ↗
• DeathOct 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IN THE SAME PROCEDURE, A FEM-FEM BYPASS WAS PERFORMED FOR THE TREATMENT OF OCCLUSIVE DISEASE OF THE ILIAC ARTERY, USING A 24MM ENDURANT II LIMB AND A BALLOON MOUNTED STENT GRAFT FROM ANOTHER MANUFACTURER. IT WAS REPORTED THAT POST PROCEDURE, AFTER FURTHER INTERVENTION, THE PATIENT EXPIRED. THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death

  MAUDE report 6960689 ↗

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