Endurant® II ETLW1616C93E (UDI 00613994991584)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994991584), received between May 8, 2017 and Feb 8, 2024 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2024Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA . IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN SHOWED A TYPE IB ENDOLEAK FROM THE RIGHT LIMB ETLW1616C93E AND ALSO A TYPE II ENDOLEAK FROM THE LUMBAR ARTERY. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668435 ↗
• MalfunctionNov 1, 2021Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM  ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED THAT DURING A FOLLOW UP CT SCAN, A SMALL TYPE 1A ENDOLEAK WAS NOTED IN THE BIFURCATE GRAFT . NO COMMUNICATION INTO THE AAA IS EVIDENT . A SLIGHT TYPE 1B ENDOLEAK WAS OBSERVED IN THE RIGHT COMMON ILIAC ARTERY. IT WAS STATED THAT THE RIGHT ILIAC HAS ONLY 6 MM OF SEAL APPROXIMATELY.  AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.  NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12727120 ↗
• InjuryFeb 24, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 110MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS LOST TO FOLLOW UP POST THE INDEX PROCEDURE. THE PATIENT PRESENTED EMERGENTLY WITH BOWEL ISSUES RELATED TO THE PATIENT¿S COLOSTOMY AND CT SIX YEARS AND FIVE MONTHS LATER SHOWED A TYPE IB ENDOLEAK OF THE RIGHT ILIAC LIMB. AN ADDITIONAL ENDURANT II STENT GRAFT LIMB ETLW1620C82E WAS IMPLANTED TO RESOLVE THE ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK WAS DUE TO THE PATIENT¿S ANATOMY. THE RIGHT COMMON ILIAC ARTERY WAS VERY TORTUOUS AND THE ORIGINAL LIMB WAS A COUPLE OF CENTIMETERS SHORT OF THE HYPOGASTRIC. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9744002 ↗
• InjuryFeb 3, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZE AORTIC ABDOMINAL ANEURYSM. IT WAS REPORTED THAT THE LEFT LIMB (ETLW1616C93E) HAD MIGRATED ON AN UNKNOWN DATE, EIGHT MONTHS POST INDEX PROCEDURE AND WAS TREATED AT THE TIME AND EXTENDED WITH AN ENDURANT II LIMB ETLW1610C199E, WHICH RESOLVED THE EVENT. AS PER THE PHYSICIAN THE CAUSE OF THIS EVENT IS ANATOMY. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR ROUTINE FOLLOW UP FOUR YEARS AND NINE MONTHS POST INDEX PROCEDURE, A CT SHOWED THE RIGHT LIMB (ETLW1620C93E) HAS MIGRATED INTO THE ANEURYSM SAC AS A RESULT OF A APPARENT TYPE IB ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE RIGHT LIMB MIGRATION IS ANATOMY, THE LIMB MIGRATED DUE TO THE TYPE IB ENDOLEAK FROM A PATENT LUMBAR ARTERY. THE PATIENT WAS NOTED TO HAVE A SHORT (25MM) COMMON ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 9658649 ↗
• InjuryMar 1, 2019Leak/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 ON 5 YEAR FOLLOW UP CT THAT A TYPE IB ENDOLEAK WAS PRESENT ON THE LEFT LIMB SIDE. THE NEXT DAY THE PHYSICIAN PERFORMED INTERVENTION WITH THE ADDITION OF BILATERAL LIMBS EXTENDING INTO THE EXTERNAL ILIACS. THE ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS DUE TO A SHORT ILIAC ARTERY THAT HAS DILATED DUE TO DISEASE PROGRESSION. THE PHYSICIAN ALSO STATED THAT THE ILIACS' WERE SHORT AND THAT IT WAS NOTED AT THE INDEX PROCEDURE THAT THE LEFT SIDE SEAL ZONE IN THE ILIAC WAS PARTICULARLY SHORT (APPROX 2CM). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8381382 ↗
• InjuryJan 25, 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 ON (B)(6) 2013. IT WAS REPORTED THAT DURING A FOLLOW-UP CT ON (B)(6) 2017, A POSSIBLE TYPE IB ENDOLEAK WAS NOTED. THE RIGHT EXTERNAL ILIAC WAS ALSO OCCLUDED. THE PHYSICIAN STATED THE CAUSE OF THE EVENT WAS ANATOMY RELATED; CONTINUED VESSEL DILATION AND UNDERSIZED STENT GRAFT. ON (B)(6) 2018 THE PHYSICIAN EXTENDED THE STENT GRAFT LIMBS TO PROVIDE SEAL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Injury

  MAUDE report 7217965 ↗
• InjuryAug 4, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 65 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY TWO YEARS AND SEVEN MONTHS POST INDEX PROCEDURE, A CT REVEALED THAT THE LEFT COMMON ILIAC ARTERY HAD DILATED AND THERE WAS A POSSIBLE DISTAL TYPE I ENDOLEAK. THE PATIENT HAD AN ANGIOGRAM. THE PHYSICIAN ELECTED TO COIL THE LEFT HYPOGASTRIC ARTERY AND TO EXTEND THE EXISTING ENDURANT STENT GRAFT INTO THE LEFT EXTERNAL ILIAC ARTERY. THE PROCEDURE WENT AS PLANNED AND THE LEFT COMMON ILIAC ARTERY ANEURYSM WAS SEALED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6766332 ↗
• InjuryMay 8, 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 A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A RECENT FOLLOW UP THE CT REVEALED THAT THE LEFT ILIAC VESSEL DISTAL TO THE LEFT ENDURANT ILIAC LIMB HAD DILATED AND HAS BECOME ANEURYSMAL. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT ILIAC LIMB. THE ILIAC ANEURYSM WAS SUCCESSFULLY EXCLUDED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO PATIENT ANATOMY OF DISEASE PROGRESSION RESULTING IN THE UNCOVERED LEFT COMMON ILIAC ARTERY BECOMING ANEURYSMAL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm

  MAUDE report 6552279 ↗

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-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