Endurant® II ETLW1610C146E (UDI 00763000519933)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000519933), received between Dec 14, 2021 and Jun 26, 2025 — classified as 4 deaths, 2 injuries, 2 malfunctions.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD PREVIOUSLY UNDERGONE TREATMENT WITH ENDURANT II STENT GRAFTS FOR AN ABDOMINAL ANEURYSM PRESENTED EMERGENTLY TO THE HOSPITAL 23 DAYS LATER WITH THROMBOSIS OF THE RIGHT ILIAC ENDURANT LIMB. THE THROMBOSIS WAS ATTRIBUTED TO DISEASE PROGRESSION AT THE DISTAL LANDING ZONE, AFFECTING THE PREVIOUSLY IMPLANTED STENT GRAFTS IN THE RIGHT ILIAC LIMB ETLW1610C146E (SN (B)(6)) AND ETLW1616C93E (SN (B)(6)), WITH A DISTAL LANDING IN THE RIGHT EXTERNAL ILIAC ARTERY. THE PATIENT UNDERWENT A SURGICAL CUT-DOWN PROCEDURE AND THROMBECTOMY OF THE AFFECTED LIMB. FOLLOWING THE THROMBECTOMY, AN ADDITIONAL 16-16-93 ENDURANT LIMB AND A 9MM NON-MDT (VIABAHN) STENTS WERE PLACED ON THE RIGHT SIDE. POST-INTERVENTION ANGIOGRAPHY CONFIRMED PATENCY, WITH NO EVIDENCE OF STENT COMPRESSION OR KINKING. THE EVENT WAS RESOLVED WITH THESE INTERVENTIONS, AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22334401 ↗
• MalfunctionMar 27, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE STENT GRAFT ETLW1610C146E ENDUR II LIMB DEVICE KINKED OUT OF THE BOX, AND THE WIRE COULD NOT BE PASSED UP DUE TO A KINKED DELIVERY SYSTEM. THE PATIENT WAS BEING TREATED FOR AN ANEURYSM WITH A SIZE OF 60MM. A REPLACEMENT DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21706898 ↗
• MalfunctionJan 8, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ENDURANT II STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE STENT GRAFT DID NOT DEPLOY. IT WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102197 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT LIMB WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 52MM AAA IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN APPROXIMATELY ONE YEAR AND FIVE MONTHS LATER SHOWED THAT THE LEFT LIMB IS OCCLUDED AND COLLATERAL FLOW WAS PRESENT. PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17279363 ↗
• DeathFeb 16, 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 59MM AAA. IT WAS REPORTED FIVE DAYS LATER, THE PATIENT WAS ADMITTED TO ED WITH BACK AND CHEST PAIN. THE PATIENT THEN WENT INTO CARDIAC ARREST AND DIED IN THE ED.  PER THE PHYSICIAN, THE CAUSE OF THE DEATH WAS A CARDIAC ARREST, THE CAUSE OF THE TYPE IA ENDOLEAK IS UNKNOWN AND THE PHYSICIAN REPORTED THE DEATH WAS NOT RELATED TO THE DEVICE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Cardiac Arrest; Pain

  MAUDE report 16384602 ↗
• DeathJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ENDURANT II LIMBS WERE IMPLANTED IN AN UNKNOWN EMERGENT ENDOVASCULAR PROCEDURE.  IT WAS REPORTED THROUGH TECHNICAL SERVICES, WHO HAD CALLED THE PHYSICIAN'S OFFICE TO GET PATIENT DETAILS FOR REGISTRATION, THAT A HCP REPORTED ON THE CALL THAT THE PATIENT HAD DIED ON THE SAME DATE AS THE IMPLANT. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information; Rupture

  MAUDE report 16136236 ↗
• DeathApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II AUI STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF 54 MM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK DIAMETER WAS NOTED AS 27 MM AND 60 MM IN LENGTH WITH MILD THROMBUS REPORTED. SEVERE RIGHT AND LEFT ILIAC CALCIFICATION WAS NOTED. IT WAS REPORTED DURING THE INDEX PROCEDURE, DURING DEPLOYMENT OF THE AUI GRAFT THE PHYSICIAN DID NOT FOLLOW IFU INSTRUCTIONS AND PULL THE GRAFT DOWN BELOW THE VIABLE RIGHT RENAL ARTERY. BEFORE BALLOONING WAS COMPLETED AN ANGIOGRAM WAS PERFORMED TO VISUALIZE THE RIGHT RENAL ARTERY. THE RIGHT RENAL ARTERY FILLED BUT SHOWED THAT THE ORIFICE WAS COVERED. THE SMA WHICH WAS 5 MM PROXIMAL TO THE RIGHT RENAL ARTERY WAS OPEN. AN ATTEMPT TO GET INTO THE RENAL ARTERY FROM THE LEFT ARM BRACHIAL APPROACH WAS UNSUCCESSFUL. THE PHYSICIAN DECIDED TO ABORT THE ENDOVASCULAR OPTION AND CONVERT TO AN OPEN AAA AORTIC REPAIR THE NEXT DAY. THE ETUF3614C102E WAS EXPLANTED AND AN AORTA BI-FEM GRAFT WAS SEWN TO THE EXISTING ENDURANT LIMB. IT WAS REPORTED THE PATIENT EXPIRED ON THE DAY OF THE OPEN REPAIR. PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION WAS DUE TO USER ERROR AND IN REFERENCE TO THE DEATH IT WAS NOTED THAT THE PATIENT WAS TOO FRAIL TO SUR

  Patient problems: Insufficient Information

  MAUDE report 14208006 ↗
• DeathDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURAT AUI STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR TREATMENT OF A 52MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE THAT AFTER THE DEPLOYMENT OF THE AUI GRAFT AND AN ENDURANT LIMB THE FINAL ANGIOGRAPHY SHOWED THE AUI DEVICE WAS APPROXIMATELY 2CM HIGHER THAN THE INTENDED LANDING ZONE BELOW THE RENALS AND THE DEVICE WAS NOW COVERING THE BOTH RENAL ARTERIES. THE PHYSICIAN ELECTED TO OPEN THE PATIENT AND PARTIALLY EXPLANT THE GRAFT COVERING THE RENAL ARTERIES AND SEW A GRAFT FROM THE RENAL TO THE RIGHT ILIAC ARTERY. ONE DAY POST THE INDEX PROCEDURE IT WAS REPORTED THE PATIENT EXPIRED. AS PER THE PHYSICIAN THE CAUSE OF THE INACCURATE DELIVERY AND OCCLUSION COULD NOT BE DETERMINED. THE CAUSE OF DEATH WAS RELATED TO DIC. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Disseminated Intravascular Coagulation (DIC)

  MAUDE report 13002774 ↗

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-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-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 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