Endurant® II ETLW1620C93E (UDI 00613994991638)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994991638), received between Jun 6, 2017 and Feb 17, 2021 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2021Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 87X78MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON THE DATE OF THE CT OVER SIX YEARS LATER, A IB ENDOLEAK FOR THE L DISTAL ENDURANT LIMB ETLW1620C93E WAS IDENTIFIED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 11336969 ↗
• InjuryJan 6, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY 6 YEARS AND 9 MONTHS LATER, TYPE IB ENDOLEAKS WERE IDENTIFIED BILATERALLY IN TWO ILIAC ENDURANT LIMBS. INTERVENTION WAS PERFORMED TWO DAYS LATER AND TWO ENDURANT LIMBS WERE IMPLANTED WHICH RESOLVED THE ENDOLEAKS. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND DISEASE PROGRESSION OF THE ILIAC ARTERIES. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11122809 ↗
• InjuryFeb 10, 2020Leak/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 UNKNOWN SIZE AORTIC ABDOMINAL ANEURYSM ON (B)(6) 2015. IT WAS REPORTED THAT THE LEFT LIMB (ETLW1616C93E) HAD MIGRATED ON AN UNKNOWN DATE EIGHT MONTHS POST THE 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 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. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A LIMB EXTENSION ON THE RIGHT SIDE. THE STENT GRAFT LIMB ETLW1628C124E WAS USED TO EXTEND THE HYPOGASTRIC AND FINAL ANGIO SHOWED NO TYPE IB ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9685694 ↗
• InjurySep 23, 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 AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT PATIENT HAD ANEURYSM GROWTH WITHOUT EVIDENCE OF ANY ENDOLEAK. AN INTERVENTION PROCEDURE WAS CARRIED OUT APPROXIMATELY FOURS YEARS AND NINE MONTHS LATER AND AN ENDURANT STENT GRAFT CUFF ETCF3232C49E, ENDURANT STENT GRAFT LIMB ETLW1620C93E AND ENDURANT STENT GRAFT LIMB ETLW1613C93E WERE IMPLANTED IN THE PATIENT AS TREATMENT. IT WAS REPORTED THAT NO ENDOLEAK WAS SEEN DURING THE PROCEDURE. THE PATIENT THEN PRESENTED WITH ABDOMINAL PAIN APPROXIMATELY ONE MONTH LATER AND CT SHOWED AN ENDOLEAK THAT APPEARED TO ORIGINATE ABOVE THE FLOW DIVIDER OF THE ORIGINAL BIFURCATED STENT GRAFT. THE GENERAL AREA OF THE ENDOLEAK WAS CONFIRMED BY ANGIO DURING AN INTERVENTION PROCEDURE CARRIED OUT THE FOLLOWING DAY. IT WAS REPORTED THAT AN ENDURANT AUI DEVICE WAS IMPLANTED AS TREATMENT. IT WAS ALSO REPORTED THAT BALLOONING WAS THEN CARRIED OUT WITH A RELIANT BALLOON, HOWEVER THE RELIANT BALLOON BURST WHEN IN THE AREA ABOVE THE FLOW DIVIDER. FURTHER ANGIO SHOWED THAT CONTRAST APPEARED TO BE LEAKING INTO THE ORIGINAL BIFURCATED STENT GRAFT AND INTO THE ANEURYSM SA

  Patient problems: Aneurysm

  MAUDE report 9104197 ↗
• InjuryAug 14, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON FOLLOW UP CT 5 YEARS LATER, DILATION OF THE DISTAL RIGHT COMMON ILIAC ARTERY WAS NOTED WITH A TYPE IB ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury; Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 8892638 ↗
• InjuryApr 2, 2019Leak/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 ON CT APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE, A TYPE IB ENDOLEAK WAS OBSERVED AT THE DISTAL LIMBS AT THE LEFT COMMON ILIAC ARTERY. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 8472994 ↗
• InjuryJun 6, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 66MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 46MM IN LENGTH, 20MM IN DIAMETER PROXIMALLY AND 17MM IN DIAMETER DISTALLY. IT WAS REPORTED THAT A CT WAS DONE AND SHOWED THAT THE ENDURANT STENT GRAFT THAT WAS IMPLANTED ON PATIENT'S RIGHT SIDE DOES NOT HAVE WALL APPOSITION. THERE WAS A TYPE IB ENDOLEAK AT THE BOTTOM OF THE PANT LEG ON THE ANTERIOR SIDE. THE RIGHT COMMON ILIAC LENGTH IS ABOUT 4CMS. THE PHYSICIAN PLACED AN ENDURANT LIMB ON THE PATIENT'S RIGHT WITH THE INTENTION TO EXTEND THE STENT GRAFT FROM THE FLOW DIVIDER TO THE INTERNAL ARTERY. THE PHYSICIAN LANDED THE LIMB EVEN WITH THE ALREADY IMPLANTED LEFT LIMB STENT GRAFT JUST BELOW THE FLOW DIVIDER AND THE END OF THE 124 STENT GRAFT LANDED APPROXIMATELY 1 CM FROM THE INTERNAL ILIAC ARTERY. THE PHYSICIAN ALSO COIL EMBOLIZED THE INTERNAL ILIAC ARTERY DUE TO CONCERN IT COULD LATER RESULT IN A TYPE II ENDOLEAK. NO OTHER VISIBLE ENDOLEAK WAS PRESENT AFTER THE LIMB WAS PLACED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO NOT ENOUGH PURCHASE OF THE EXISTING STENT GRAFT AND DILATION OF THE VESSEL. NO ADDITIONAL CLINIC

  Patient problems: Injury

  MAUDE report 6616450 ↗

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-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-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