Endurant® II ETLW1620C146E (UDI 00763000388997)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000388997), received between Apr 8, 2021 and Feb 24, 2022 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT BIFURCATED STENT GRAFT WAS IMPLANTED DURING 90 MM ABDOMINAL AORTIC ANEURYSM . IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM UNDER A YEAR LATER, A CT WAS CARRIED OUT AND EVIDENCE OF A TYPE I ENDOLEAK AND RUPTURED ABDOMINAL AORTIC ANEURYSM WAS OBSERVED. THE PHYSICIAN CARRIED OUT EMERGENCY SURGERY AND THE PATIENT EXPIRED DURING THE PROCEDURE. IT WAS REPORTED THAT BOTH TYPE IA AND TYPE IB ENDOLEAK WERE OBSERVED. IT IS BELIEVED THAT THE TYPE LB ENDOLEAK IS COMING AROUND THE ETLW1613C156E SN (B)(4) AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS AS A RESULT OF A PULMONARY EMBOLISM. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAD EXPIRED.

  Patient problems: Pulmonary Embolism; Rupture

  MAUDE report 13590056 ↗
• InjuryJul 21, 2021Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 64MM X 54MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE RIGHT ETLW1620C124E LIMB WAS PLACED SHORT OF ANTICIPATED LANDING ZONE AND REQUIRED A LIMB EXTENSION BEING PLACED. THE LEFT EXTERNAL ILIAC ARTERY WAS DISSECTED DURING ACCESS AND A ETEW2020C82E STENT WAS IMPLANTED TO TREAT THE DISSECTION. TWO DAYS LATER, THE PATIENT PRESENTED EMERGENTLY WITH COLD PULSELESS LEGS. A CTA WAS PERFORMED WHICH SHOWED THE RIGHT ILIAC ETLW1620C146E DEVICE WAS KINKED AND THROMBOSED, THE LEFT EXTERNAL ILIAC WAS THROMBOSED ALSO. INTERVENTION WAS PERFORMED, THE PHYSICIAN PERFORMED BILATERAL FEMORAL CUTDOWNS AND BILATERAL EMBOLECTOMIES. A NON MDT STENT WAS PLACED IN THE KINKED RIGHT LIMB AND THEN BOTH LIMBS WERE BALLOONED AT THE SAME TIME TO 16MMS. IT WAS REPORTED, THE CAUSE OF THE DISSECTION TO THE LEFT EXTERNAL ILIAC WAS CAUSED DURING ACCESS WHICH THE PHYSICIAN FELT WAS A CAUSE OF INADEQUATE VISUALIZATION WITH FLUORO UNIT AND PT SIZE. IT WAS ALSO REPORTED, THE 20 PORTION OF THE LEFT LIMB WAS NEXT TO THE 16 PORTION OF THE RIGHT LIMB AND ONCE THE DISSECTED LEFT EXTERNAL ILIAC SHUT

  Patient problems: Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 12201678 ↗
• InjuryApr 8, 2021Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 83 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PATIENT HAD A LARGE ANEURYSM WITH MINIMAL NECK BELOW RENALS ARTERY. THE PHYSICIAN THEN DECIDED TO PERFORM BILATERAL CHIMNEYS FOR THIS PROCEDURE. FINAL ANGIOGRAM WAS PERFORMED, WHERE IT WAS NOTED WHAT APPEARED TO BE A GUTTER LEAK. AN ANGIOGRAM WAS PERFORMED ABOUT 6 WEEKS LATER AND IT WAS DETERMINED THE PATIENT HAD A TYPE 1B ENDOLEAK FROM THE RIGHT LIMB ETLW1620C146E (B)(4). INTERVENTION WAS PERFORMED FOR THE IB ENDOLEAK WHERE ANOTHER ENDURANT LIMB ETLW1620C156E WAS IMPLANTED DOWN TO THE RIGHT HYPOGASTRIC ARTERY. THIS RESOLVED THE IB ENDOLEAK. AS PER THE PHYSICIAN THERE APPEARED TO BE NO GUTTER ENDOLEAK PRESENT. AS PER THE PHYSICIAN, THE CAUSE OF THE GUTTER ENDOLEAK EVENT WAS ANATOMY RELATED DUE TO A SHORT AORTIC NECK BELOW THE RENALS ARTERY. THE PHYSICIAN STATED THE REASON FOR THE IB ENDOLEAK WAS DUE TO NOT HAVING ENOUGH GRAFT IN THE RIGHT ILIAC ARTERY NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11632824 ↗

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-0290-2022 · Oct 15, 2021 · Open, Classified
  Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
• 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
• 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