Endurant® II ETBF2316C145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994991201), received between Mar 22, 2018 and Aug 13, 2024 — classified as 1 death, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

2 FDA recall records name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Dec 21, 2021Open, Classified

   Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.

   Z-0657-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Feb 27, 2017Terminated

   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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• DeathAug 13, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS (VNMF3731C173TU & VNMC3131C90TU) A PHYSICIAN MODIFIED BRANCH GRAFT AND AN ENDURANT II STENT GRAFT SYSTEM WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL ANEURYSM. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY AND WAS HOSPITALIZED FOR A STREPTOCOCCUS MITIS BACTERAEMIA INFECTION, WITH POSSIBLE FOCUS OF INFECTION AT THE AORTIC ENDOGRAFT IN THE DESCENDING THORACIC AORTA. DUE TO THE SUSPICION OF GRAFT INFECTION, A THREE-PHASE WHITE BLOOD CELL WAS COMPLETED WHICH DID NOT SHOW ANY ACTIVE INFLAMMATION IN THE GRAFT AREA. ULTIMATELY THE PATIENT WAS DISCHARGED 6 DAYS LATER ON IVAB. FOLLOWING ANOTHER HOSPITALIZATION APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE, THE PATIENT HAD A REPEAT WBC SCAN WHICH SHOWED SUBTLE UPTAKE AROUND THE GRAFT. THE PATIENT WAS GIVEN A TREATMENT PLAN TO CONTINUE ANTIBIOTIC TREATMENT WITH THE ADDITIONAL ANTIBIOTIC ADDED. THE CAUSE OF THE INFECTION WAS LIKELY ASSOCIATED WITH 5 ENDURANT STENT GRAFT SINCE NUCLEAR MEDICINE TAGGED WBC SCAN SHOWED UPTAKE IN THE DESCENDING THORACIC AORTA AT THE SITE OF ENDURANT GRAFT. AN ENDOLEAK WAS OBSERVED AND ALSO ASSOCIATED WITH THE B

  Patient problems: Intracranial Hemorrhage; Unspecified Infection

  MAUDE report 19971056 ↗
• MalfunctionJul 7, 2021Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  AN ENDURANT II STENT GRAFT WAS ATTEMPTED TO BE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 63MM AAA DURING THE PROCEDURE IT WAS REPORTED, WHILE TRYING TO INSERT THE DEVICE THROUGH MODERATELY CALCIFIED ILIAC ARTERIES, THE GRAFT COVER BECAME CAUGHT AND ACCORDION. THE DEVICE WAS THEN REPLACED WITH ANOTHER GRAFT OF THE SAME SIZE AND THE PROCEDURE WAS COMPLETED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY DUE TO CALCIUM IN THE ARTERIES NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127038 ↗
• InjuryNov 22, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 51 MM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK DIAMETER MEASURED 19-21 MM WITH A NECK LENGTH OF 30MM. THE DIAMETER AT THE LEVEL OF THE AORTIC BIFURCATION MEASURED 31 MM. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE STENT GRAFT SYSTEM WAS IMPLANTED, FINAL ANGIOGRAM SHOWED THAT THE BIFURCATED GRAFT WAS PARTIALLY COVERING THE LEFT RENAL ARTERY. ADDITIONALLY, AN ENDOLEAK WAS APPRECIATED AT THE LEVEL OF THE CONTRA-LATERAL GATE. THE PHYSICIAN FELT THE ENDOLEAK COULD BE JUNCTIONAL RELATED AND RE-BALLOONED THE OVERLAPPING SEGMENT OF THE CONTRA-LATERAL LIMB. A REPEAT ANGIOGRAM DEMONSTRATED PERSISTENT ENDOLEAK AT THE SAME LEVEL SO THE PHYSICIAN DECIDED TO RE-EVALUATE AT LATER DATE. AN ADDITIONAL ANGIOGRAM WAS PERFORMED TO CONFIRM THE PROXIMAL LOCATION OF THE STENT GRAFT. THE LEFT RENAL ARTERY WAS FILLING BUT WAS PARTIALLY COVERED SO THE PHYSICIAN ELECTED TO IMPLANT A 7X20MM BALLOON EXPANDABLE STENT. A FINAL ANGIOGRAM DEMONSTRATED GROSS PATENCY OF THE LEFT RENAL ARTERY AND THE PROCEDURE WAS COMPLETED. PER THE PHYSICIAN THE CAUSE OF THE RENAL OCCLUSION WAS DUE TO USER ERROR. THE

  Patient problems: Occlusion

  MAUDE report 9361658 ↗
• InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED TO HOSPITAL WITH ABDOMINAL PAIN ON AN UNKNOWN DATE. THE STENT GRAFT WAS EXPLANTED AND ALTHOUGH THE PROCEDURE REPORTEDLY WENT WELL, THE PATIENT THEN PRESENTED WITH POST-OPERATIVE BLEEDING AND PAIN AT A DIFFERENT FACILITY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME..

  Patient problems: Abdominal Pain; Blood Loss; No Consequences Or Impact To Patient; Occlusion; Pain; Thrombus

  MAUDE report 8398334 ↗
• MalfunctionMar 22, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 56MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE DIAMETER OF THE AORTA AT THE RENAL ARTERY WAS 17 MM AT IMPLANT, AND THE PROXIMAL LENGTH AT IMPLANT WAS 15-20 MM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AN UNKNOWN TYPE LEAK WAS PRESENT ON ANGIOGRAM. IT IS NOTED TO BE POSSIBLY A TYPE IV OR A TYPE III AS PER THE PHYSICIAN. THE PHYSICIAN ELECTED TO COMPLETE THE PROCEDURE AND FOLLOW UP IN 2 WEEKS. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7361040 ↗

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