Endurant® II ETLW1628C93E (UDI 00613994991331)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994991331), received between May 28, 2019 and May 20, 2022 — classified as 1 death, 3 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM ON THE.  IT WAS REPORTED THE PATIENT PRESENT EMERGENTLY WITH PAIN WHERE A CT SCAN SHOWED THE RIGHT COMMON ILIAC ARTERY, WHICH HAD A ETLW1628C93E LIMB IN IT, DILATED UP TO 40MM. THE PHYSICIAN COILED THE RIGHT INTERNAL AND EXTENDED WITH AN ENDURANT LIMB INTO THE RIGHT EXTERNAL ILIAC ARTERY.  AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO ANATOMY AND CONTINUED VESSEL DILATION.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; Pain

  MAUDE report 14451747 ↗
• InjuryNov 10, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING A FOLLOW-UP CT APPROXIMATELY 8 YEARS POST THE INDEX PROCEDURE ENLARGEMENT OF THE PATIENTS LEFT CIA WAS NOTED AND THE ANEURYSM WAS NOW 120MM. THE LIMB (16X28X93) HAD RETRACTED INTO THE AAA SAC. AN INTERVENTION WAS CARRIED OUT WHERE AN AUI WAS IMPLANTED AND ISSUE WAS RESOLVED.  PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO CIA ENLARGEMENT. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm

  MAUDE report 12786025 ↗
• DeathOct 16, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY FOUR YEARS LATER WITH A CONTAINED ANEURYSM RUPTURE. A CT SCAN SHOWED A TYPE IA ENDOLEAK. A NON-MDT (GORE) CUFF WAS IMPLANTED TO ADDRESS THE ENDOLEAK, ALONG WITH ENDOANCHORS. IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO DECOMPRESS THE ABDOMINAL COMPARTMENT, AND IN DOING SO THE RETROPERITONEAL CAVITY GAVE WAY. AFTER MUCH EFFORT TO SAVE THE PATIENT IT WAS REPORTED THAT THE PATIENT DIED. IT WAS REPORTED THAT A POSSIBLE TYPE IIIA ENDOLEAK WAS NOTED AFTER OPENING THE ANEURYSM SAC PERI-MORTEM. AS PER THE PHYSICIAN, THE CAUSE OF THE TYPE IA ENDOLEAK WAS EITHER STENT GRAFT MIGRATION OR AORTIC DILATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT HAS EXPIRED.

  Patient problems: Death; Rupture

  MAUDE report 9197072 ↗
• InjuryMay 28, 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 ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT APPROXIMATELY 5 YEARS POST IMPLANT, CT WAS PERFORMED WHICH SHOWED A TYPE IB ENDOLEAK IN THE RIGHT COMMON ILIAC DUE TO RETRACTION OF THE ENDURANT LIMB. THE PATIENT WAS SUCCESSFULLY TREATED 10 DAYS LATER WITH A LIMB EXTENSION. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO DISEASE PROGRESSION IN THE RIGHT COMMON ILIAC. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 8645191 ↗

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-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