Endurant® II ETLW1613C199ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169467705), received between Mar 7, 2017 and May 2, 2024 — classified as 2 deaths, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation 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 18, 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.

• DeathMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 8 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED AAA. THE PHYSICIAN SUSPECTED A TYPE IA ENDOLEAK WAS THE LIKELY CAUSE OF THE RUPTURE BUT WAS NOT DISCOVERED DUE TO THE PATIENT BEING LOST TO FOLLOW-UP . AS TREATMENT THE PATIENT UNDERWENT AN OPEN REPAIR OPERATION AND THE ESBF3214C103E AND LIMBS WERE EXPLANTED. THERE WAS NO COMPLAINT AGAINST THE LIMBS. THE PATIENT SURVIVED THE PROCEDURE BUT EXPIRED THE FOLLOWING DAY. PER THE PHYSICIAN THE CAUSE OF THE RUPTURE WAS LIKELY RELATED TO THE TYPE IA ENDOLEAK. IN REFERENCE TO THE CAUSE OF DEATH. THE PHYSICIAN NOTED THAT THE PATIENT WAS ON ANTICOAGULATION MEDICATION AND HAD ABDOMINAL COMPARTMENT SYNDROME.

  Patient problems: Swelling/ Edema

  MAUDE report 19228160 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT LIMB WAS IMPLANTED DURING THE TREATMENT OF  A LEFT ILIAC ANEURYSM. IT WAS REPORTED  THAT A ROUTINE FOLLOW UP CT PERFORMED IDENTIFIED AN  OCCLUSION OF THE LEFT ILIAC LIMB. THE PATIENT HAD SOME BUTTOCK PAIN BUT HADN'T CONTACTED THE PHYSICIAN DUE TO MINOR PAIN. PER THE PHYSICIAN, THE CAUSE OF THE OCCLUSION WAS DUE TO THE PATIENT'S TORTUOUS LEFT ILIAC ANATOMY. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16110846 ↗
• MalfunctionMay 18, 2021Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS ATTEMPTED IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A TYPE 1B ENDOLEAK FROM PRIOR EVAR DONE 5 YEARS BEFORE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER INSERTING THE ENDURANT LIMB THROUGH TORTUOUS ILIACS ARTERIES, THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE THE GRAFT BUT THE GRAFT COVER WASN'T COMING DOWN WHILE DEPLOYING. THE DEVICE WAS THEN REMOVED FROM THE PATIENT, WHERE IT WAS NOTED THAT THE STENT RING WAS PROTRUDING THROUGH OF THE GRAFT COVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER STENT GRAFT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11840450 ↗
• DeathOct 16, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 90 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE BIFURCATED STENT GRAFT WAS SUCCESSFULLY IMPLANTED, HOWEVER, THE STENT GRAFT LIMB ETLW1613C199E COULD NOT BE TRACKED THROUGH THE ILIAC ARTERY. THE PHYSICIAN THEN SUCCESSFUL DODDERED A 12F SHEATH AND A SECOND ATTEMPT WAS MADE TO TRACK THE DEVICE, BUT THIS WAS AGAIN UNSUCCESSFUL. A 16F DILATOR WAS THEN SUCCESSFULLY TRACKED THROUGH THE ILIAC USING THE SAME DODDERING TECHNIQUE AND A THIRD ATTEMPT WAS MADE TO TRACK THE DEVICE, BUT THIS WAS AGAIN UNSUCCESSFUL. IT WAS REPORTED THAT AFTER THE DELIVERY SYSTEM WAS REMOVED THE PATIENT¿S BLOOD PRESSURE DROPPED. ANGIOGRAM PERFORMED AND AN ILIAC RUPTURE WAS NOTED. THREE NON-MDT COVERED STENTS WERE PLACED, BUT THE PATIENT CONTINUED TO CRASH. AN ENDURANT AUI DEVICE ETUF2814C102E WAS THEN IMPLANTED INSIDE THE BIFURCATED STENT GRAFT AND EXTENDED WITH AN ENDURANT STENT GRAFT LIMB ETLW1613C156E. THE PATIENT REMAINED UNSTABLE AND THE PHYSICIAN DECIDED TO CONVERT TO AN OPEN REPAIR. THE BLEEDING WAS CONTROLLED, A FEM-FEM BYPASS WAS CARRIED OUT AND THE MIDLINE INCISION LEFT OPEN/PACKED. AS PER THE PHYSI

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation of Vessels; Rupture

  MAUDE report 9196758 ↗
• InjuryApr 26, 2017Adverse 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 48 MM DIAMETER ABDOMINAL AORTIC ANEURYSM AND ILIAC ARTERY ANEURYSM. IT WAS REPORTED THAT THE INTERNAL ILIAC WAS EMBOLIZED WITH ANOTHER MANUFACTURER¿S OCCLUDER BEFORE THE ENDURANT STENT GRAFT WAS IMPLANTED. THE PATIENT CAME IN FOR THE 30 DAY FOLLOW UP AND THE SCAN REVEALED ALMOST COMPLETE AAA THROMBOSIS AND TWO LUMBAR ARTERIES WERE STILL PATENT. IT WAS REPORTED THAT THE PATIENT PRESENTED 12 DAYS LATER TO AN ER WITH FEVER AND CHILLS. ANOTHER SCAN WAS DONE AND REVEALED AN AREA OF INFECTION OR AN ABSCESS. THE PATIENT WAS TRANSFERRED FROM THE ORIGINAL FACILITY TO ANOTHER FACILITY FOR FURTHER TREATMENT. THE PHYSICIAN STATED THAT THE AREA OF CONCERN IS WITH THE OTHER MANUFACTURER¿S OCCLUDER PLUG. THE PHYSICIAN DECIDED TO EXPLANT THE OTHER MANUFACTURER¿S OCCLUDER PLUG DUE TO THE INFECTION. THE ENDURANT ILIAC LIMB WAS PARTIAL EXPLANTED AND THE ILIAC ARTERY WAS LIGATED ON THE RIGHT SIDE, THEN A FEM-FEM BYPASS WAS DONE TO PERFUSE BOTH ILIAC ARTERIES. PER THE PHYSICIAN, THE OTHER MANUFACTURER¿S OCCLUDER DEVICE AND THE ENDURANT ILIAC LIMB WERE BOTH SENT OUT FOR ANALYSIS AND THE RESULTS CAME BACK AS

  Patient problems: Fever

  MAUDE report 6524777 ↗
• InjuryMar 7, 2017Occlusion Within Device; Occlusion Within Device

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT A FUSIFORM 5.1 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM, 3.2 CM IN DIAMETER RIGHT COMMON ILIAC ARTERY ANEURYSM, AND 2.4 CM IN DIAMETER LEFT COMMON ILIAC ARTERY ANEURYSM. IT WAS REPORTED THAT THE ENDURANT STENT GRAFTS WERE SUCCESSFULLY IMPLANTED AND THE RIGHT INTERNAL ILIAC ARTERY WAS ALSO COILED. THE PATIENT PRESENTED AT FOLLOW UP AND STATED THAT THEY HAVE CHRONIC NUMBNESS IN THE RIGHT THIGH. THE CT REVEALED THAT CLAUDICATION OF THE RIGHT LOWER EXTREMITY AND THE ENDURANT 16X199 STENT GRAFT IN THE RIGHT COMMON ILIAC ARTERY WAS OCCLUDED. THE PHYSICIAN ELECTED TO PERFORM A RETROPERITONEAL INCISION ON THE RIGHT SIDE OF THE PATIENT TO GET EXPOSURE TO THE RIGHT EXTERNAL ILIAC ARTERY. THE PHYSICIAN THEN PERFORMED A THROMBECTOMY AND PULLED THE ORGANIZED CLOT FROM THE RIGHT SIDE LIMB AND EXTENDED UP TO THE FLOW DIVIDER. THE PHYSICIAN PLACED A BALLOON EXPANDABLE STENT IN THE CONTRALATERAL GATE OF THE ENDURANT IIS BIFURCATE THAT EXTENDED FROM THE FLOW DIVIDER TO THE END OF THE CONTRALATERAL GATE. THE PHYSICIAN POST DILATED THE BALLOON EXPANDABLE STENT UP TO 14 MM IN DIAMETER AND THEN SUTURED THE DISTA

  Patient problems: Numbness; Occlusion

  MAUDE report 6385685 ↗

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-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