Endurant® II ETLW1610C199ERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169467620), received between Feb 27, 2017 and Nov 23, 2020 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ENDURANT LIMB WAS INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZE RUPTURED ANEURYSM &IB ENDOLEAK. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, WHEN THE BACK END WHEEL WAS ROTATED , THE GRAFT DIDN'T RELEASE FROM THE PROXIMAL END AND CONTINUED TO COME BACK UNDER THE GRAFT COVER AND APPEARED TO BE STUCK. THIS STENT GRAFT WAS THEN REMOVED. 2 SHORTER LIMBS WERE THEN IMPLANTED TO ACHIEVE THE REQUIRED LENGTH INSTEAD. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10885673 ↗
• InjuryFeb 28, 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 60MM ABDOMINAL AORTIC ANEURYSM. THE LEFT COMMON ILIAC ARTERY DIAMETER MEASURED 58MM-26MM WITH MILD CALCIFICATION NOTED. IT WAS REPORTED THAT FOLLOW UP CT IDENTIFIED LEFT LIMB OCCLUSION IN THE ETLW1610C199E ((B)(4)) & ETLW1610C156E ((B)(4)). FROM REVIEW OF THE CT, THE PHYSICIAN NOTED THE LEFT EXTERNAL APPEARED PATENT FROM THE COLLATERALS AND THE PATIENT IS ASYMPTOMATIC. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED LIKELY DUE TO VESSEL TORTUOSITY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Occlusion

  MAUDE report 8377286 ↗
• MalfunctionJan 14, 2019Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  THE RESISTANCE WAS ENCOUNTERED WHEN INSERTING THE DEVICE INTO THE FEMORAL ARTERY. THE FEMORAL ARTERY WAS NOTED AS 8.5MM IN DIAMETER AND NOTED AS DISEASE FREE. A SHEATH WAS NOT USED WHEN INSERTING THE ENDURANT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8244151 ↗
• MalfunctionNov 21, 2018Defective Component; Malposition of Device; Device Markings/Labelling Problem; Defective Component; Malposition of Device; Device Markings/Labelling Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE AS THE ENDURANT LIMB WAS BEING DEPLOYED ON THE RIGHT IPSI SIDE AN ESBF3614C103E ENDURANT IIS BIFURCATE, THE PROXIMAL MARKER WAS LINED UP WITH FLOW DIVIDER. THE PHYSICIAN TURNED THE HANDLE AND UPON DEPLOYMENT THE LIMB STENT GRAFT WAS PARTIALLY DEPLOYED IN THE IPSILATERAL SIDE OF THE BIFURCATED STENT GRAFT. IT WAS NOTED THAT THE PHYSICIAN WAS SURE THAT THE STENT GRAFT WAS LANDED AT THE APPROPRIATE LANDING ZONE BUT THE DEVICE THEN DROPPED BY 30MM. AT THAT POINT, THE PHYSICIAN RE-CHECKED THE BOX AND PACKAGING TO ENSURE THE PROPER DEVICE WAS OPENED. IT IS CONFIRMED TO BE THE CORRECT LIMB THAT THE PHYSICIAN REQUIRED AS PER THE PACKAGING. IT WAS STATED THAT THE PHYSICIAN VERIFIED THE MEASUREMENT VIA A MARKING PIGTAIL CATHETER ON THE DEPLOYED LIMB. IT APPEARED TO MEET THE MEASUREMENTS OF A 156 LENGTH LIMB NOT THE 199 LENGTH THAT WAS LABELED. THE PHYSICIAN WAS ABLE TO KEEP WITHIN THE 30MM PROXIMAL OVERLAP AND DISTAL SEAL WAS ACHIEVED WITHOUT THE USE OF FURTHER EXTENSION DEVICES. PER THE PHYSICIAN, THE CAUSE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8094161 ↗
• MalfunctionApr 12, 2018Break; Difficult to Insert; Break; Difficult to Insert

  AN ENDURANT II STENT GRAFT SYSTEM WAS PLANNED FOR IMPLANTATION IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 53MM ABDOMINAL AORTIC ANEURYSM. DURING THE INDEX PROCEDURE THE PHYSICIAN CLAIMED THAT THE ENDURANT II LIMB WOULD NOT ADVANCE WHEN ATTEMPTING TO LOAD THE DEVICE INTO A 16F SENTRANT SHEATH AND NOTED THAT THE TIP OF THE DEVICE WAS BENT. THE PHYSICIAN CLAIMS THAT THE ENDURANT II LIMB DELIVERY SYSTEM WAS DEFECTIVE. A SHORTER LENGTH ENDURANT II LIMB WAS USED DURING THE INDEX PROCEDURE TO RESOLVE THE EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7424567 ↗
• MalfunctionOct 24, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS NOT COMPLAINT WITH FOLLOW UP APPOINTMENTS. A RECENT CT REVEALED THAT THERE WAS A THERE WAS GOOD PROXIMAL SEAL ALL THE WAY UP TO THE LOWEST RENAL ARTERY HOWEVER THERE IS A DISTAL TYPE IB ENDOLEAK ON THE RIGHT, IPSILATERAL SIDE AND THERE WAS LOSS OF STENT GRAFT SEAL ON THE LEFT, CONTRALATERAL SIDE. THERE WAS ALSO A3CM SACCULAR ANEURYSM NOTED AT THE DISTAL RIGHT COMMON ILIAC. PER THE INVESTIGATOR, THE DISTAL TYPE I ENDOLEAK AND THE LOSS OF SEAL ARE RELATED TO THE PATIENT¿S ANATOMY, DILATATION OF THE ILIAC LIMB. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN. IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED TO FIX AT TYPE IB ENDOLEAK ON THE RIGHT LIMB. IT WAS NOTED THAT THE LEFT LIMB ONLY HAD 5 MM OF SEAL BEFORE IT COULD BE PULLED UP INTO THE ANEURYSMAL SAC ALSO. DURING THE PROCEDURE, A LEFT EXTENSION LIMB WAS IMPLANTED WITHOUT ISSUE. WHILE ATTEMPTING TO DEPLOY THE RIGHT EXTENSION LIMB, AN ISSUE OCCURRED WITH THE FULL DEPLOYMENT OF THE STENT GRAFT. THE PHYSICIAN WA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6970966 ↗
• InjuryApr 18, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AN UNKNOWN DATE THE PATIENT PRESENTED FOR ANOTHER MEDICAL CONDITION AND THE CT REVEALED THAT THERE WAS ENDURANT ILIAC LIMB OCCLUSION. THE ENDURANT RIGHT ILIAC LIMB UP TO THE AORTIC BIFURCATION WAS OCCLUDED. NO INTERVENTION WAS PERFORMED DUE TO MULTIPLE INFECTIONS THAT THE PHYSICIAN NOTED WERE UNRELATED TO THE DEVICE OR PROCEDURE. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS RELATED TO THE OVERSIZING OF THE ENDURANT ILIAC LIMB. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

  Patient problems: Occlusion

  MAUDE report 6500588 ↗
• MalfunctionFeb 27, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CLAUDICATION IN THEIR LEFT LEG. A CT REVEALED THAT THE LEFT LIMB HAD COMPLETELY THROMBOSED AND THAT THE THROMBUS HAD PROPAGATED UP INTO THE MAIN BODY FROM THE FLOW DIVIDER UP TO THE TOP OF THE GRAFT. THE PHYSICIAN ALSO STATED THAT THE LEFT LIMB APPEARED COMPRESSED AT THE LEVEL OF THE FLOW DIVIDER. ADDITIONALLY, THE PHYSICIAN THOUGHT THAT THERE APPEARED TO BE A NARROWING IN THE RIGHT PROXIMAL EXTERNAL ILIAC ARTERY JUST BELOW THE RIGHT LIMB. THE PHYSICIAN THOUGHT THAT THE NARROWING OF THE ARTERY MAY BE IMPEDING FLOW AND CONTRIBUTING TO THE BUILDUP OF THROMBUS IN THE MAIN BODY. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

  Patient problems: Occlusion

  MAUDE report 6362541 ↗

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-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-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