Endurant® II ETEW2828C82ERecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994991416), received between May 23, 2018 and Aug 15, 2023 — classified as 7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2023Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 70MM RUPTURED ABDOMINAL AORTIC ANEURYSM AND LARGE ILIAC ANEURYSM. THE ILIAC WAS NOTED AS LARGE, DILATED AND TORTUOUS. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCDURE, FOLLOW UP CT SHOWED A POSSIBLE TYPE IIIA ENDOLEAK IN THE LEFT ILIAC. INTERVENTION WAS COMPLETED. AN ENDURANT ILIAC LIMB EXTENSION WAS IMPLANTED TO RESOLVE THE TYPE IIIA ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE TYPE IIIA ENDOLEAK WAS DUE TO ANATOMY - THE PATIENT WAS ORIGINALLY TREATED FOR A LARGE AAA WITH A TORTUOUS DILATED ILIAC AND USER ERROR DUE TO UNDERSIZING.

  Patient problems: Insufficient Information

  MAUDE report 17547969 ↗
• MalfunctionJul 20, 2023Leak/Splash; Leak/Splash

  TWO ENDURANT LIMBS EXTENSIONS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. A VALIANT NAVION STENT GRAFT WAS IMPLANTED AP PROXIMATELY 2 YEARS PREVIOUS TO THE INDEX PROCEDURE. IT WAS REPORTED A CT APPROXIMATELY 3 MONTHS POST THE IMPLANT OF THE LIMBS. CORELAB HAVE REVIEWED THIS IMAGING AND IDENTIFIED A TYPE IB ENDOLEAK FROM THE LEFT ILIAC ARTERY AND LEFT THORACOABDOMINAL BRANCH PERFUSING ANEURYSM SAC. NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17359936 ↗
• InjuryMay 16, 2023Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55M ABDOMINAL AORTIC ULCER. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE PHYSICIAN TRIED TO ADVANCE THE 28X28X82 THROUGH THE FEMORAL ARTERY THAT WAS EXPOSED VIA CUTDOWN. THE DEVICE WOULD NOT ADVANCE EVEN WITH ROTATION. THE PHYSICIAN REMOVED THE DELIVERY SYSTEM OVER THE WIRE HOWEVER, UPON REMOVAL NOTICED THE TIP WAS MISSING. FLUOROSCOPY TO THE PATIENT'S RIGHT GROIN WAS PERFORMED AND IT SHOWED THE TIP WAS LODGED IN THE PATIENT'S ILIAC ARTERY. THE ILIAC ARTERY RUPTURED WHEN ATTEMPTING TO REMOVE THE TIP. THE RUPTURE WAS REPAIRED AND THE TIP WAS REMOVED SURGICALLY. A REPLACEMENT ENDURANT STENT WAS THEN SUCCESSFULLY IMPLANTED. PER THE PHYSICIAN THE CAUSE WAS DUE TO OVERSIZING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Perforation of Vessels

  MAUDE report 16937472 ↗
• InjuryJun 24, 2021Leak/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. APPROXIMATELY 4 YEARS POST PROCEDURE, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL, WITH CT IMAGING SHOWING A TYPE IIIA SEPARATION OF THE GRAFT COMPONENTS. THE PHYSICIAN THEN DECIDED TO BRIDGE THE COMPONENTS WITH A ETTF3636C70E (SN (B)(4)). THE EVENT WAS RESOLVED AND NO ENDOLEAK WAS OBSERVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12058604 ↗
• InjuryNov 13, 2019Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND AN ADDITIONAL ENDURANT II STENT GRAFT LIMB ETEW2828C82E WAS IMPLANTED AS A SECONDARY LIMB EXTENSION APPROXIMATELY FOUR YEARS AND NINE MONTHS LATER. IT WAS REPORTED THAT FOLLOW UP CT APPROXIMATELY SEVEN YEARS AND NINE YEARS LATER SHOWED A DISTAL TYPE IB ENDOLEAK WITH THE RIGHT COMMON ILIAC MEASURING 31MM. A SECONDARY PROCEDURE WAS CARRIED OUT AND THE RIGHT INTERNAL ILIAC ARTERY WAS COILED AND A STENT GRAFT LIMB ETLW1610C199E PLACED TO THE EXTERNAL ILIAC ARTERY. FINAL ANGIOGRAM SHOWED NO EVIDENCE OF A ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK WAS DISEASE PROGRESSION OF THE RIGHT COMMON ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9315532 ↗
• InjuryOct 31, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT CT APPROXIMATELY 4 YEARS AND 7 MONTHS POST IMPLANTATION OF THE STENT GRAFT LIMB V05914694 SHOWED A SUSPECTED TYPE IIIA ENDOLEAK. A RE-INTERVENTION PROCEDURE WAS CARRIED OUT APPROXIMATELY 3 AND A HALF WEEKS LATER AND THE TYPE IIIIA ENDOLEAK WAS CONFIRMED BY ANGIO. IT WAS REPORTED THAT THE ENDOLEAK OCCURRED BETWEEN THE ORIGINAL LEFT STENT GRAFT LIMB V05914694 AND THE EXTENSION LIMB V08231427 THAT HAD BEEN LATER ADDED. A STENT GRAFT LIMB ETLW1628C199E WAS USED TO RELINE THE STENT GRAFT FROM THE FLOW DIVIDER TO THE INTERNAL ILIAC ARTERY AND THE EVENT WAS REPORTED TO BE RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9259396 ↗
• MalfunctionOct 3, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT LIMB WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 37MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 4 MONTHS 10 DAYS POST IMPLANT, A TYPE IA ENDOLEAK WAS NOTED ON THE PATIENT'S CTA. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9150084 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE STENT GRAFTS WERE IMPLANTED THE PATIENT WAS SUTURED USING PERCLOSE. WHILE BEING TRANSFERRED OFF THE OT TABLE THE PATIENT'S CONDITION DETERIORATED INTO CARDIAC ARREST AND A LARGE ABDOMINAL HEMATOMA WAS NOTED. THE PHYSICIAN ELECTED TO PERFORM AN OPEN REPAIR WHERE IT WAS CONFIRMED THE PERCLOSE FAILED CAUSING VESSEL RUPTURE. THE INJURY WAS RESOLVED POST OPEN REPAIR AND THE PATIENT WAS TRANSFERRED TO THE ICU. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO SUTURE FAILURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Cardiac Arrest; Hematoma; Rupture

  MAUDE report 8594921 ↗
• InjuryMay 23, 2018Malposition of Device; Malposition of Device

  A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE TREATMENT OF AN 6.5CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A TYPE II ENDOLEAK WAS IDENTIFIED IN THE TALENT STENT GRAFT SYSTEM ON CT PERFORMED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE. AN ENDURANT II ILLAC EXTENSION WAS IMPLANTED TO TREAT THE ENDOLEAK. THE TARGET LOCATION FOR THE ENDURANT II ILIAC EXTENSION WAS THE ILIAC BIFURCATION. IT WAS REPORTED THAT UPON FULL DEPLOYMENT OF THE GRAFT THAT THE GRAFT WAS DEPLOYED ABOVE THE RENAL ARTERIES. THE PHYSICIAN PERFORMED AN ANGIOGRAM WHICH SHOWED PATENT FLOW TO THE CELIAC AXIS, SMS AND RENAL ARTERIES. THE PHYSICIAN DECIDED TO IMPLANT TWO MORE STENTS DISTAL TO THE STENT GRAFT THAT DEPLOYED ABOVE THE RENALS TO OCCLUDE THE ENDOLEAK AND THE EVENT IS REPORTED AS BEING RESOLVED. THE PHYSICIAN REPORTED THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7537208 ↗

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-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 aort
• 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 i
• 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