Endurant® II ETLW1620C82E (UDI 00643169467521)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169467521), received between Jun 19, 2017 and Nov 10, 2023 — classified as 3 injuries, 3 malfunctions.

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

• MalfunctionNov 10, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHEN ETLW1624146 (B)(6) BOX WAS OPENED DURING A PROCEDURE, THE SEALED LIMB CONTAINED INSIDE WAS ETLW1620C82E - SERIAL # (B)(6). THE DEVICE CONTAINED WITHIN THE BOX WITH SERIAL # (B)(6). IT WAS REPORTED THAT NONE OF THE DEVICES WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18109807 ↗
• InjuryJun 9, 2021Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 51 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT WAS PERFORMED TWO DAYS LATER, WHERE A TYPE 1B ENDOLEAK WAS NOTED IN THE LEFT COMMON ARTERY. A ETLW1620C82E WAS IMPLANTED TO TREAT THE EVENT. THE ENDOLEAK WAS RESOLVED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS USER ERROR NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11967095 ↗
• MalfunctionDec 10, 2019Difficult to Insert; Difficult to Insert

  AN ENDURANT II STENT GRAFT LIMB WAS PLANNED TO BE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN AORTIC ILIAC ANEURYSM. IT WAS REPORTED THAT THE DEVICE WAS PREPPED ON THE BACK TABLE TO GET READY FOR IMPLANT. IT WAS REPORTED THAT THE STIFF WIRE WOULD NOT PASS THROUGH THE WIRE LUMEN OF THE DELIVERY SYSTEM. THE DEVICE WAS NOT PLACED IN THE PATIENT. ANOTHER STENT GRAFT LIMB ETLW1620C93E WAS USED INSTEAD. AS PER THE PHYSICIAN, THE EVENT WAS DEVICE RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9444154 ↗
• InjuryAug 1, 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 92 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY 5 YEARS LATER WITH A RAPIDLY GROWING ANEURYSM (INCREASE OF 10MM OVER 6 MONTHS) AND BELLY PAIN. ANEURYSM EXPANSION WAS ALSO PREVIOUSLY NOTED 2 YEARS AND 6 MONTHS PREVIOUS, HOWEVER NO CAUSE WAS NOTED ON EITHER OCCASION. IT WAS ASSUMED THAT A TYPE II LEAK WAS PRESENT, AND THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFT . UPON EVACUATION OF THE AORTA, A LARGE AMOUNT OF PUS WAS NOTED, AND GRAM NEGATIVE COCCI CULTURE WAS VERIFIED. UPON VISUALIZATION, A STITCH POP/HOLE IN THE BIFURCATE STENT GRAFT WAS NOTED, WHICH WAS INVISIBLE ON THE CT SCAN WITH BLOOD SHOOTING OUT OF THE HOLE/HOLES THAT THE STITCH HAD MADE IN THE FABRIC. AFTER EXPLANT OF ALL ENDURANT STENT GRAFTS, AN ANTIBIOTIC WASH OUT OF THE INFECTED AREA WAS CARRIED OUT AND AN AXIBIFEM BYPASS WAS COMPLETED. THE PHYSICIAN DID NOT BELIEVE THE ANEURYSM GROWTH TO BE RELATED TO THE STENT GRAFT LEAK, BUT RATHER TO THE INFECTION. THE CAUSE OF THE STITCH/POP HOLE IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain; Aneurysm; Unspecified Infection

  MAUDE report 8849783 ↗
• MalfunctionSep 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AN ENDURANT II STENT GRAFT WAS SELECTED AND INSERTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE MARKER PIG TAIL CATHETER WAS PLACED AT THE FLOW DIVIDER. RETROGRADE INJECTION WAS DONE TO MARK THE TAKE-OFF OF THE INTERNAL ILIAC ARTERY. MARKS WERE COUNTED WHICH INDICATED AN 82 LENGTH LIMB SHOULD BE USED. IT WAS REPORTED THAT WHEN THE 82 LIMB WAS INSERTED IT WAS OVER 1CM SHORT BEFORE DEPLOYMENT. THE PHYSICIAN FELT THIS WAS AN UNACCEPTABLE LENGTH DISCREPANCY AND THE DEVICE WAS REMOVED FROM THE PATIENT. A 93 LENGTH ENDURANT LIMB WAS USED INSTEAD WITH NO ISSUES. THE PHYSICIAN STATED THE CAUSE OF THE EVENT WAS DEVICE RELATED (82 LIMB LENGTH WAS INACCURATE). NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6847598 ↗
• InjuryJun 19, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH LEFT LEG PAIN. A CT SCAN SHOWED OCCLUSION DUE TO STENOSIS OF THE ENDURANT STENT GRAFTS IN THE LEFT LIMB. THE PATIENT RECEIVED AN INTERVENTION. THE PHYSICIAN PERFORMED A CUT DOWN ON THE LEFT COMMON FEMORAL ARTERY, INSERTED A GUIDEWIRE AND CATHETER THAT WERE ADVANCED UP TO THE OCCLUSION. THE PHYSICIAN USED AN ANGIOJET TO DECLOT THE OCCLUSION IN THE LEFT LIMB. THE COMPLETION ANGIOGRAM SHOULD THE ENDURANT STENT GRAFTS WERE PATENT WITH NO COMPLICATION. THE PHYSICIAN REVIEWED THE ONE MONTH CT SCAN AND NOTED TWO AREAS OF STENOSIS AT THE END OF THE ENDURANT BIFURCATED STENT GRAFT AND THE MIDDLE OF THE ENDURANT ILIAC LIMB WHICH RESULTED IN THE OCCLUSION OF THE ENDURANT STENT GRAFTS. PER THE PRIMARY PHYSICIAN, THE CAUSE OF THE OCCLUSIONS AND STENOSIS WAS DUE TO THE PATIENT¿S ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion; Pain

  MAUDE report 6651283 ↗

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-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-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-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