Endurant® II ETLW1628C156E (UDI 00643169467446)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169467446), received between Jan 3, 2017 and Dec 8, 2023 — classified as 1 death, 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 8 YEARS POST THE INDEX PROCEDURE, FOLLOW-UP IMAGING IDENTIFIED BILATERAL TYPE IB ENDOLEAKS AND A SUSPECTED TYPE IA ENDOLEAK ON THE CTA. IT WAS NOTED THE PATIENT IS ASYMPTOMATIC, BUT DUE TO THE SIZE OF THE 97MM AAA, RE-INTERVENTION WILL BE PERFORMED. PER THE PHYSICIAN THE CAUSE OF THE BILATERAL TYPE IB ENDOLEAK AND SUSPECTED TYPE IA ENDOLEAK IS DUE TO DISEASE PROGRESSION LEADING TO LOSS OF ADEQUATE PROXIMAL AND DISTAL SEALS. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290511 ↗
• InjuryMay 25, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA ON THE.  IT WAS REPORTED A CT WAS PERFORMED , WHERE IB ENDOLEAKS WERE IDENTIFIED, THE LIMBS HAD LOST SEAL DISTALLY.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 17001333 ↗
• MalfunctionMay 8, 2023Leak/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 A 106MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT IDENTIFIED A TYPE IB ENDOLEAK FROM THE LEFT ILIAC LIMB. THE 28MM FLAIR ILIAC LIMB APPEARS TO HAVE MIGRATED PROXIMALLY INTO THE ANEURYSM SAC. PER THE PHYSICIAN THE CAUSE OF THE MIGRATION AND ENDOLEAK IS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885157 ↗
• DeathJan 25, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM AND ENDURANT EXTENSION WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 90MM AAA .  IT WAS REPORTED, A CT SHOWED AN ENDOLEAK. AN ELECTIVE PROCEDURE WAS PERFORMED TO EXPLANT THE STENT GRAFTS DUE TO AN ENLARGING AAA AND POSSIBLE TYPE IA ENDOLEAK. THE TYPE IA ENDOLEAK WAS CONFIRMED DURING THE EXPLANT PROCEDURE. IT WAS REPORTED THE PATIENT EXPIRED DURING THIS EXPLANT PROCEDURE. IT WAS SAID THE PATIENT DIED DUE TO COMPLICATIONS RESULTING FROM THE EXPLANT PROCEDURE.  THE CAUSE OF THE TYPE IA ENDOLEAK WAS REPORTED AS DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 16239313 ↗
• InjuryJul 6, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 76MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT CAME IN FOR ROUTINE FOLLOW-UP AND A CT PERFORMED OVER 5 YEARS LATER SHOWED THE LEFT COMMON ILIAC ARTERY HAD DILATED CAUSING A IB ENDOLEAK WHERE THE STENT GRAFT ETLW1628C156E WAS IMPLANTED. INTERVENTION WAS PERFORMED WHERE THE PHYSICIAN TRIED TO EXTEND THE LEFT ILIAC ARTERY, BUT EXPERIENCED DIFFICULTY ADVANCING GUIDE WIRES AND CATHETERS. AFTER MULTIPLE ATTEMPTS IT WAS DECIDED TO ABORT THE PROCEDURE. THE PHYSICIAN THEN CREATED A RIGHT TO LEFT FEMORAL TO FEMORAL BYPASS PRIOR TO CEASING THE PROCEDURE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 12120492 ↗
• InjuryApr 30, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 37MM LEFT COMMON ILIAC ANEURYSM. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT REVEALED AN INCREASE IN THE ILIAC ANEURYSM SIZE DUE TO POSSIBLE ENDOTENSION. INTERVENTION WAS COMPLETED WITH AN EXTENSION PLACED INTO THE EXTERNAL ILIAC AND COILING PERFORMED. THE EVENT WAS CONFIRMED AS RESOLVED WITH SEAL ACHIEVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS POSSIBLY DUE TO ENDOTENSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8564416 ↗
• MalfunctionJun 1, 2018Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE TREATMENT OF A 56 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A BILATERAL ILIAC ANEURYSM WAS OBSERVED ON (B)(6) 2018 FOLLOWING A FOLLOW UP CT SCAN OF THE PATIENT. THE PHYSICIAN REPORTED THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS BEING MONITORED.

  Patient problems: Aneurysm

  MAUDE report 7560341 ↗
• InjuryJan 9, 2018Leak/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 THAT APPROXIMATELY 3 MONTHS POST INDEX PROCEDURE, AN ANGIOGRAM WAS PERFORMED WHICH APPEARED TO SHOW A TYPE IB ENDOLEAK IN THE LEFT COMMON ILIAC ARTERY. IT WAS REPORTED THAT THE EVENT WAS RESOLVED FEW DAYS LATER WITH THE EXTENSION OF THE LIMB DOWN TO THE LEFT HYPOGASTRIC WITH AN ENDURANT ILIAC EXTENSION. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED (DUE TO INSUFFICIENT EXTENSION OF THE STENT GRAFT INTO THE LEFT CIA TO ENSURE COMPLETE COVERAGE). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7174356 ↗
• InjuryDec 20, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY AT THE EMERGENCY DEPARTMENT WITH SEVERE BACK PAIN. A CT WAS DONE AND SHOWED THE PATIENT HAD A CONTAINED ABDOMINAL AORTIC ANEURYSM RUPTURE. AS PER THE PHYSICIAN, THE CAUSE OF THE RUPTURE WAS ANATOMY RELATED DUE TO A DEVELOPED ILIAC ANEURYSM CAUSING A TYPE IB ENDOLEAK. THE PHYSICIAN ADVISED THE PATIENT HAD NOT ATTENDED ANY OF THE POST IMPLANT FOLLOW UPS AFTER INITIAL AAA TREATMENT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY OCCLUDING THE RIGHT COMMON ILIAC ARTERY WITH AN AMPLATZ PLUG AND IMPLANTING TWO ENDURANT STENT GRAFTS (B)(4) AND (B)(4) TO EXCLUDE THE RIGHT COMMON ILIAC ARTERY AND RUPTURED AREA. THE PATIENT'S BLOOD PRESSURE WAS STABILIZED AND THE PATIENT WAS WALKING RELATIVELY PAIN FREE THE FOLLOWING DAY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 7132900 ↗
• InjuryJan 3, 2017Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 9 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY ELEVEN MONTHS POST INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN. A CT REVEALED THAT THE LEFT ENDURANT II STENT GRAFT LIMB HAD MIGRATED INTO THE ANEURYSM SAC AND THERE WAS A DISTAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO EXTEND THE LEFT ILIAC LIMB INTO THE LEFT EXTERNAL ILIAC ARTERY AND THE EVENT WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO A VERY TORTUOUS PATIENT ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6220373 ↗

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