Endurant® II ETLW1613C82E (UDI 00643169467699)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169467699), received between Mar 7, 2017 and Jul 18, 2024 — classified as 2 deaths, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Occlusion Within Device” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 66MM AAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A LEFT SIDED OCCLUSION OCCURRED AFFECTING THE STENT GRAFTS ETLW1613C93E (B)(6) AND ETLW1613C82E (B)(6). INTERVENTION WAS PERFORMED AND A 32 ENDURANT AUI AND 36 ENDURANT CUFF WERE IMPLANTED. A FEM-FEM BYPASS WAS PERFORMED ALSO PERFORMED WITH THE IMPLANT OF A NON MDT PLUG. IT WAS ALSO NOTED THAT THERE WAS AN EXTRAVASATION IN THE PROXIMAL RIGHT EXTERNAL ILIAC ARTERY (REIA), DISTAL TO THE RIGHT LIMB CAUSED BY A NON-MEDTRONIC THROMBECTOMY CATHETER. THE REMOVAL OR DELIVERY OF THE STENT GRAFTS DID NOT CAUSE ANY INJURY IN THE REIA. PER THE PHYSICIAN THE PROBABLE CAUSE OF OCCLUSION WAS PATIENT ANATOMY. IT WAS NOTED THE PATIENT HAD CALCIFIED ACCESS VESSELS. THE EXTRAVASATION OF BLOOD WAS CAUSED BY THE THROMBECTOMY DEVICE. IT WAS THEN REPORTED THE PATIENT EXPIRED THE FOLLOWING DAY. THE CAUSE OF DEATH IS UNKNOWN BUT AS PER THE PHYSICIAN NOT RELATED TO THE ENDURANT STENT GRAFTS. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED .

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion

  MAUDE report 19772427 ↗
• DeathNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM AND VALIANT STENT GRAFT WAS IMPLANTED IN A PATIENT DURING AN UNKNOWN AORTIC ENDOVASCULAR PROCEDURE. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE, THE PATIENT PRESENTED TO THE ER. A CT SCAN IDENTIFIED A TYPE IA ENDOLEAK AND RUPTURED AAA. THE PATIENT EXPIRED ON THE DAY OF THE RUPTURE. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK RUPTURE AND DEATH IS UNDETERMINED.

  Patient problems: Ruptured Aneurysm

  MAUDE report 10894951 ↗
• InjuryJan 3, 2018Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD A VERY TORTUOUS ILIAC WITH A 90 DEGREE BEND. BECAUSE OF THIS, THE PHYSICIAN DECIDED TO EXTEND THE BIFURCATED STENT GRAFT DURING THE INDEX PROCEDURE, USING A LIMB. IT WAS REPORTED THAT DURING A FOLLOW-UP, IT WAS NOTED THAT THE PATIENT HAD AN OCCLUDED LEFT LIMB. THE PHYSICIAN TREATED THE OCCLUSION BY IMPLANTATION OF A STAINLESS-STEEL STENT AND REMOVAL OF THE CLOT. THE PHYSICIAN STATED THE CAUSE OF THE EVENT WAS ANATOMY RELATED, DUE TO THE TORTUOUS ILIAC. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 7159521 ↗
• MalfunctionSep 22, 2017Device Expiration Issue; Device Expiration Issue

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE HOSPITAL OWNED ENDURANT STENT GRAFT THAT WAS IMPLANTED ONE DAY POST EXPIRY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6885870 ↗
• InjuryAug 24, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A GREATER THAN 55 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT, APPROXIMATELY ONE YEAR AND SEVEN MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL AND BACK PAIN. IT WAS DISCOVERED THAT THE ENDURANT II STENT GRAFT SYSTEM HAD BILATERAL DISTAL TYPE I ENDOLEAKS. THE PHYSICIAN ELECTED TO IMPLANT BILATERAL ILIAC LIMB EXTENSIONS AND IMPLANTED A PROXIMAL EXTENSION. THE PROXIMAL EXTENSION WAS IMPLANTED AS A PROACTIVE THERAPY TO ELIMINATE ANY UNDEFINED OR NON-IDENTIFIED PROXIMAL ENDOLEAKS. THE EVENT WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO DILATATION OF THE COMMON ILIAC ARTERIES FROM THE DISEASE STATE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; Pain

  MAUDE report 6816118 ↗
• InjuryMar 7, 2017Occlusion Within Device; Occlusion Within Device

  ADDITIONAL INFORMATION RECEIVED. THE OCCLUSION EXTENDED TO THE LEVEL OF THE FLOW DIVIDER AND KINKING WAS OBSERVED IN THE PROXIMAL IPSILATERAL LIMB OF THE AORTIC BIFURCATION.

  Patient problems: Occlusion; Pain

  MAUDE report 6385769 ↗

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-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