Endurant® IIs ESBF3614C103E (UDI 00763000306359)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000306359), received between Sep 28, 2021 and Dec 14, 2021 — classified as 1 death, 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A RUPTURED 75MM ABDOMINAL AORTIC ANEURYSM. DURING THE INDEX PROCEDURE AFTER IMPLANTING THE STENT GRAFT SYSTEM IT WAS REPORTED THE PATIENT EXPIRED.  AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO THE ABDOMINAL AORTIC ANEURYSM RUPTURE. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Rupture

  MAUDE report 13001611 ↗
• InjurySep 28, 2021Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 64MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED THAT DURING THE PROCEDURE, THE ENDURANT IIS BIFURCATE ((B)(4)) STENT GRAFT WAS INSERTED VIA THE RIGHT COMMON FEMORAL ARTERY. THE DEVICE WOULDN'T TRANSVERSE THE CALCIFIED ILIAC ARTERIES.  THE PHYSICIAN THEN USED A DILATOR TO DILATE AND PERFORMED A BALLOON ANGIOPLASTY. THE SAME DEVICE WAS THEN TRIED TO BE INSERTED ONCE AGAIN, BUT WAS NOT ABLE TO PASS THROUGH THE CALCIFIED VESSELS. THE PHYSICIAN THEN INSERTED A BARE METAL STENT WITHIN THE RIGHT EXTERNAL ILIAC ARTERY TO OPEN UP THE CALCIFIED AREA. A 9MM X 59MM NON MDT STENT (NON MDT) WAS UTILIZED AND INFLATED MULTIPLE TIMES WITH A 10MM AND 12MM BALLOON. THEN THE PHYSICIAN  TOOK A NEW ENDURANT BIFURCATE (#(B)(4)) AND THIS WAS INSERTED WITHOUT ISSUE. THE STENT GRAFT THEN DEPLOYED WITHOUT ISSUE, THE CONTRALATERAL GATE WAS CANNULATED AND CONTRALATERAL LIMB WAS ADVANCED OVER A STIFF WIRE.  THEN AN ENDURANT LIMB (V30578676) WAS ADVANCED WITHIN THE LEFT COMMON ILIAC ARTERY BUT COULD NOT BE ADVANCED PAST THE PROXIMAL COMMON ILIAC DUE TO THE CALCIFIED ARTERIES. THE LEFT COMMON ILIAC WAS THEN BALLOONED BU

  Patient problems: Perforation of Vessels

  MAUDE report 12538867 ↗

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-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