Endurant® II ETLW1610C82E (UDI 00643169467613)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169467613), received between Sep 9, 2019 and May 23, 2023 — classified as 1 death, 1 injury.

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

• DeathMay 23, 2023Adverse 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 50MM AAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE BIFURCATE MAIN BODY WAS PLACED WITHOUT ISSUE, THE PHYSICIAN HAD MUCH DIFFICULTY CANNULATING THE GATE AND MUCH TIME WAS SPENT UTILIZING MANY TACTICS TO DO SO. THE PHYSICIAN PROCEEDED TO COMPLETE THE ISPI (RIGHT) SIDE BY REMOVING THE MAIN BODY'S DELIVERY SYSTEM AND COMPLETING RIGHT SIDE BY ADDING A  ETLW1610C82E (B)(6) WITHOUT ISSUE.  THE PHYSICIAN THEN BEGAN ATTEMPTING TO CANNULATE THE GATE AGAIN. AT THIS TIME THE ANESTHESIOLOGIST ALERTED THE PHYSICIAN TO A SLOWLY DECLINING BLOOD PRESSURE.  CONTRAST WAS THEN INJECTED TO VISUALIZE THE LEFT ILIAC BUT NO EXTRAVASATION WAS SEEN. THE PHYSICIANS ALSO  PERFORMED AN ANGIOGRAM  WITH A  CATHETER PROXIMAL TO RENAL ARTERIES  AND NOTED NO EXTRAVASATION. THE ANESTHESIOLOGIST STABILIZED THE PATIENT AS THE PHYSICIAN  CONTINUED TO TRY  TO CANNULATE THE GATE. THE PATIENTS BLOOD PRESSURE DROPPED AGAIN AND A REPEAT ANGIOGRAM SHOWED EXTRAVASATION IN THE PROXIMAL LEFT ANEURYSM. AN ENDURANT AUI WAS THEN PLACED ALONG WITH A NON MDT VASCULAR PLUG TO OCCLUDE THE LEFT ILIAC ARTERY, THEREBY EXCLUDING FLOW

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 16982745 ↗
• InjurySep 9, 2019Adverse 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 30 MM DIAMETER RIGHT ILIAC AND DISTAL ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 6 MONTHS POST IMPLANT WITH A LIMB OCCLUSION ON THE RIGHT SIDE. THE PATIENT RECEIVED TREATMENT ON THE SAME DAY. AN EMBOLECTOMY WAS CARRIED OUT AND THE LIMB WAS REALIGNED. A CUFF WAS ALSO USED TO TRAP THE RETAINED THROMBUS. IT WAS REPORTED THAT FLOW WAS GOOD AT THE END OF THE PROCEDURE AND THE OCCLUSION WAS RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS THAT THE PATIENT UNDERWENT SPINAL SURGERY AND WAS PRONE FOR A PERIOD OF TIME. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 8974759 ↗

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