Endurant® II ETBF2313C145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994991171), received between Dec 16, 2016 and Oct 2, 2023 — classified as 1 death, 9 injuries.

The most frequently reported specific device problem is “Leak/Splash” (5 reports).

1 FDA recall record name this device's identifier.

5 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.

Recalls naming this device

1. Feb 27, 2017Class IITerminated

   Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.

   Z-1543-2017 · Root cause: Packaging change control · Recall details · FDA record ↗

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.

• InjuryOct 2, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON FOLLOW UP CT APPROXIMATELY 9 YEARS AND 2 MONTHS LATER PATIENT'S AORTIC ANEURYSM WAS GROWING DUE TO TWO TYPE IB ENDOLEAKS. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO PATIENT'S ANATOMY. THE PHYSICIAN BELIEVES THAT THE LIMBS PULLED OUT BECAUSE THE PATIENT IS SHRINKING IN HEIGHT. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 17849843 ↗
• InjuryJan 10, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE REPAIR OF A 69MM ABDOMINAL AORTIC ANEURYSM . THE PATIENT HAD A 8MM LONG AORTIC NECK AND HAD 9 ENDOANCHORS IMPLANTED. IT WAS REPORTED THAT A 1 MONTH FOLLOW-UP CT SHOWED THE PRESENCE OF A PROXIMAL TYPE I ENDOLEAK. THE DEVICE IS AT THE LEVEL OF THE RENAL ARTERIES. AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK WAS DUE TO THE PATIENTS OWN ANATOMY AS A RESULT OF SHORT NECK WITH ANGULATION. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 13202888 ↗
• InjurySep 9, 2021Adverse 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 A 35X43 MM PENETRATING ATHEROSCLEROTIC ULCER (PAU). IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY THE FOLLOWING MONTH WITH AN OCCLUDED LEFT LIMB THAT APPEARED TO BE COMPROMISED AT THE AORTIC BIFURCATION. A SECONDARY PROCEDURE WAS CARRIED OUT. A THROMBECTOMY WAS CARRIED OUT, THE BIFURCATION WAS STENTED IN THE BILATERAL LIMBS AND THE LEFT ILIAC LIMB WAS RELINED WITH A 16X10X124 DEVICE. THE EVENT WAS REPORTED TO BE RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO PATIENT ANATOMY DUE TO A TIGHT BIFURCATION. IT WAS THEN REPORTED THE PATIENT PRESENTED EMERGENTLY COMPLAINING OF ABDOMINAL PAIN ON OVER 2 AND A HALF YEARS LATER. A CT SHOWED TOTAL OCCLUSION OF THE EVAR DEVICES. THROMBECTOMY WAS PERFORMED THE FOLLOWING DAY WITH RELINING OF THE GRAFTS USING NON MDT EXPANDABLE STENTS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12445873 ↗
• InjuryJun 14, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60 MM ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 4 YEARS POST PROCEDURE, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH COMPLAINTS OF BACK PAIN. A CT WAS PERFORMED, WHERE A TYPE 1 ENDOLEAK AND ENLARGED SAC WERE NOTED. AN AORTIC CUFF AND APTUS ENDOACHORS WERE IMPLANTED TO TREAT THE EVENT. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 11991738 ↗
• InjuryMar 5, 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 PHONED TECHNICAL SERVICES TO REPORT EXPLANT OF THEIR STENT GRAFT SYSTEM DUE TO AN UNKNOWN ENDOLEAK APPROXIMATELY 2 YEARS AND 8 MONTHS POST IMPLANT.

  Patient problems: Injury

  MAUDE report 8389636 ↗
• InjuryNov 6, 2018Obstruction of Flow; Obstruction of Flow

  A THROMBECTOMY WAS PERFORMED TO CLEAN OUT THE THROMBUS AND AN ADDITIONAL STENT WAS IMPLANTED TO RELINE THE LIMB AND RESOLVE THE EVENT. THE PATIENT STATUS HAS BEEN CONFIRMED AS GOOD.

  Patient problems: Injury; No Consequences Or Impact To Patient; Thrombus

  MAUDE report 8041092 ↗
• DeathJun 7, 2017Device Damaged by Another Device; Device Damaged by Another Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 44MM IN LENGTH, 19MM IN DIAMETER PROXIMALLY AND 21MM IN DIAMETER DISTALLY. THE LEFT ILIAC ARTERY WAS 9MM, 8MM 10MM IN DIAMETER FROM PROXIMAL TO DISTAL AND IT WAS CALCIFIED. THE RIGHT ILIAC ARTERY WAS 10MM, 13MM IN DIAMETER FROM PROXIMAL TO DISTAL AND IT WAS CALCIFIED. THE EXTERNAL ILIAC ARTERIES WERE 7MM IN DIAMETER BILATERALLY. THE AORTIC BIFURCATION WAS NARROW MEASURING 17MM IN DIAMETER. THERE WAS NO ENDOLEAK POST IMPLANT AND BOTH LIMBS WERE PATENT. IT WAS REPORTED THAT A SUSPECTED PERCLOSE FAILURE WAS TREATED WITH AN OPEN PROCEDURE ON THE LEFT COMMON FEMORAL. THE PATIENT RETURNED AGAIN EMERGENTLY AND THE LEFT LIMB AND EXTERNAL ILIAC WERE OCCLUDED AND THE STENT GRAFT WAS ASSESSED WITH IVUS. THE PROXIMAL LEFT LIMB WAS COMPROMISED / PINCHED BY THE RIGHT LIMB IN THE DISTAL AORTA. THROMBUS WAS PRESENT IN THE LEFT LIMB AND EXTERNAL ILIAC ARTERIES. THE PATIENT WAS TREATED WITH ANGIOJET TO MINIMIZE THROMBUS BURDEN IN THE LIMB AND DISTAL MAIN BODY. THE LEFT LIMB WAS TREATED BY PLACEMENT OF ANOTHER MANUFACTURER¿S STENT AND BILATERAL

  Patient problems: Death

  MAUDE report 6619989 ↗
• InjuryApr 12, 2017Occlusion Within Device; Occlusion Within Device

  ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT HAS EXPERIENCED PAIN AND OTHER BLOOD CLOTS.

  Patient problems: Embolus; Occlusion; Pain

  MAUDE report 6486942 ↗
• InjuryJan 27, 2017Material Deformation; Material Deformation

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 70MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM WITH A PRE-OPERATIVE RUPTURE. IT WAS REPORTED THAT A FOLLOW UP CT SCAN OBSERVED LIMB COMPRESSION AGAINST THE NORMAL DISTAL AORTA. THE PHYSICIAN PERFORMED AN INTERVENTION AND IMPLANTED A BALLOON EXPANDABLE STENT AND THE EVENT WAS RESOLVED. THE PHYSICIAN THEN ELECTED TO IMPLANT ADDITIONAL BALLOON EXPANDABLE STENTS BILATERALLY AS A PROPHYLACTIC. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6283960 ↗
• InjuryDec 16, 2016Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. MORPHOLOGY AT IMPLANT IS UNKNOWN; HOWEVER, AT THE TIME OF THE INTERVENTION THE NECK ANGULATION WAS 79 DEGREES. TORTUOSITY WAS NOTED AS MODERATE AND CALCIFICATION WAS MILD. IT WAS REPORTED THAT A FOLLOW UP CT REVEALED A TYPE IA ENDOLEAK. IT WAS NOTED THAT THE DEVICE APPEARED TO BE PLACED 3CM BELOW THE LOWEST MAIN RENAL ARTERY, HOWEVER, IT WAS NOTED THAT THE GRAFT WAS JUST BELOW AN ACCESSORY RENAL ARTERY WHICH PROVIDED A LARGE PORTION OF BLOOD FLOW TO THE RIGHT KIDNEY. A 25X25X70 ENDURANT II AORTIC EXTENSION WAS IMPLANTED AND THE LOWEST ACCESSORY RENAL WAS INTENTIONALLY COVERED. THIS RESOLVED THE EVENT. THE PHYSICIAN STATED THAT 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 6181403 ↗

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-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-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