Endurant® II ETEW2020C82ERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994991393), received between Apr 17, 2017 and Feb 18, 2025 — classified as 1 death, 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 16, 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.

• MalfunctionFeb 18, 2025Defective Component; Positioning Problem; Defective Component; Positioning Problem

  AN ENDURANT ETEW2020C82E LILAC EXTENSION WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A ULCER. IT WAS CONFIRMED THE DEVICE WAS PRE PPED AND OPENED IN THE STANDARD FASHION. PERCUTANEOUS ACCESS WAS ESTABLISHED AND THE DEVICE WAS LOADED ON THE WIRE AND ADVANCED TO ACCESS SITE BAREBACK. THE DEVICE WOULD NOT ENTER THE ARTERY AND WAS STUCK AT THE ACCESS SITE. THE DEVICE WAS REMOVED AND A 16FR SHEATH WAS USED TO DELIVER AND DEPLOY THE STENT GRAFT. THE CAUSE OF THE DIFFICULTY INSERTING THE DEVICE WAS FOUND TO BE A 3-5MM GAP BETWEEN THE TAPERED TIP AND GRAFT COVER WHICH CAUSED A LIP WHICH LED TO THE DEVICE GETTING STUCK AT THE ACCESS SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399971 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 64MM X 54MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE RIGHT ETLW1620C124E LIMB WAS PLACED SHORT OF ANTICIPATED LANDING ZONE AND REQUIRED A LIMB EXTENSION BEING PLACED. THE LEFT EXTERNAL ILIAC ARTERY WAS DISSECTED DURING ACCESS AND A ETEW2020C82E STENT WAS IMPLANTED TO TREAT THE DISSECTION. TWO DAYS LATER, THE PATIENT PRESENTED EMERGENTLY WITH COLD PULSELESS LEGS. A CTA WAS PERFORMED WHICH SHOWED THE RIGHT ILIAC ETLW1620C146E DEVICE WAS KINKED AND THROMBOSED, THE LEFT EXTERNAL ILIAC WAS THROMBOSED ALSO. INTERVENTION WAS PERFORMED, THE PHYSICIAN PERFORMED BILATERAL FEMORAL CUTDOWNS AND BILATERAL EMBOLECTOMIES. A NON MDT STENT WAS PLACED IN THE KINKED RIGHT LIMB AND THEN BOTH LIMBS WERE BALLOONED AT THE SAME TIME TO 16MMS. IT WAS REPORTED, THE CAUSE OF THE DISSECTION TO THE LEFT EXTERNAL ILIAC WAS CAUSED DURING ACCESS WHICH THE PHYSICIAN FELT WAS A CAUSE OF INADEQUATE VISUALIZATION WITH FLUORO UNIT AND PT SIZE. IT WAS ALSO REPORTED, THE 20 PORTION OF THE LEFT LIMB WAS NEXT TO THE 16 PORTION OF THE RIGHT LIMB AND ONCE THE DISSECTED LEFT EXTERNAL ILIAC SHUT

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12201676 ↗
• DeathAug 2, 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 AN INFRARENAL ULCER. IT WAS REPORTED THE PATIENT PRESENTED WITH SEPSIS OVER A YEAR LATER. REVIEW OF CT AND THE PATIENT¿S HISTORY LED THE TO A DIAGNOSIS OF AN INFECTED AORTA WITH DISEASE PROGRESSION OF THE DISTAL AORTA. THE DEVICE WAS EXPLANTED AS TREATMENT A DAY LATER. IT WAS REPORTED THAT THE PATIENT HAS AN AORTOENTERIC FISTULA WHEN THE STENT GRAFT WAS REMOVED, AND THE AORTA AND COMMON ILIAC ARTERIES WERE LIGATED DURING THE PROCEDURE. IT WAS REPORTED POST PROCEDURE THE PATIENT DEVELOPED SEPSIS AND HAD TO BE RETURNED TO THE OR FOR RE-LIGATION OF THE RIGHT COMMON ILIAC ARTERY. THE PATIENT SUCCUMBED TO SEPSIS AND DIED A FEW DAYS POST PROCEDURE. THE ACTUAL DATE OF DEATH IS UNKNOWN. PER THE PHYSICIAN THE CAUSE WAS DUE TO POSSIBLE INFECTION AND DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Aneurysm; Death; Fistula; Unspecified Infection

  MAUDE report 8854663 ↗
• MalfunctionJun 12, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER THE PLACEMENT OF THE STENT GRAFTS, BALLOONING WAS PERFORMED IN ALL AREAS AND KISSING BALLOONS WERE USED AT THE FLOW DIVIDER WITH WHAT APPEARED TO BE MORE FORCE THAN IS REQUIRED. ON FINAL ANGIOGRAM, THERE WAS CONTRAST FILLING THE ANEURYSM SAC AND AN EXTENSION WAS IMPLANTED TO GIVE 10-15MM MORE SEAL IN THE RIGHT COMMON ILIAC ARTERY TO ATTEMPT TO RESOLVE THIS. FURTHER ANGIOGRAM STILL SHOWED CONTRAST IN THE SAC AND WERE PERFORMED TO TRY RULE OUT A TYPE IA AND TYPE IB ENDOLEAK. ANGIOGRAM PERFORMED AT THE BODY OF THE STENT GRAFT ALSO SHOWED CONTRAST FILLING THE SAC. IT WAS CONSIDERED BY THE PHYSICIAN THAT THERE MAY HAVE BEEN A TYPE IIIB ENDOLEAK OR A TYPE II ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNDETERMINED BUT IF A TYPE IIIB ENDOLEAK MAY HAVE BEEN RELATED TO OVER BALLOONING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8690885 ↗
• InjuryNov 7, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 51MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AN ENDURANT LIMB WAS USED TO EXTEND A 1620X124 BY 4CM INTO THE LEFT COMMON ILIAC ARTERY. IT WAS REPORTED THAT THE PHYSICIAN BALLOONED THE LIMB AND AN ANGIOGRAM WAS PERFORMED. IT WAS OBSERVED THAT A STENOTIC LESION APPROXIMATELY 15 MM PROXIMAL TO THE DISTAL ASPECT OF THE EXTENSION LIMB HAD PERFORATED/RUPTURED THE VESSEL. THE PERFORATION/RUPTURE WAS COVERED BY AN ENDURANT CUFF HOWEVER A TYPE IV ENDOLEAK WAS OBSERVED, WITH CONTRAST SLOWLY MOVING INTO THE RETROPERITONEAL CAVITY. THE PHYSICIAN DECIDED TO RE-LINE WITH ANOTHER ENDURANT ILIAC LIMB AND THIS COMPLETELY RESOLVED THE ISSUE. THE CAUSE OF THE EVENT, AS PER THE PHYSICIAN, WAS ANATOMY RELATED, DUE TO THE STENOTIC, CALCIFIED AND THROMBOSED LESION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7005494 ↗
• InjuryJul 11, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II ILIAC LIMB STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A MID AORTA 33MM PENETRATING ATHEROSCLEROTIC ULCER (PAU). IT WAS REPORTED THAT AFTER THE STENT GRAFT WAS PLACED IT WAS BALLOONED WITH A RELIANT BALLOON. FOLLOWING ANGIO INDICATED FILLING OF PAU STILL REMAINED, WHICH WAS A POSSIBLE TYPE I OR TYPE II ENDOLEAK. THE PHYSICIAN RE-BALLOONED THE STENT GRAFT AND SUBSEQUENT ANGIO RUNS SHOWED A DISSECTION OF THE AORTA WITH EXTENSION INTO THE LEFT RENAL ARTERY. SEVERAL MORE ANGIO RUNS WERE PERFORMED AND THE PHYSICIAN DETERMINED THE BEST COURSE OF ACTION WAS TO PERFORM POST OP CTA TO CONFIRM NOT RUPTURE. THE PHYSICIAN STATED THE CAUSE OF THE DISSECTION WAS BALLOONING. THE CAUSE OF THE ENDOLEAK INTO THE PAU IS UNKNOWN; HOWEVER, ANGIO SHOWS FILLING OF LUMBARS PRIOR TO FILLING OF PAU. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Injury

  MAUDE report 6703938 ↗
• InjuryApr 28, 2017Malposition of Device; Malposition of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 4.0 CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT, DURING THE IMPLANT PROCEDURE, THE GRAFT SIZE (23 X 23 X 70) THAT THE PHYSICIAN WANTED TO USE WAS UNAVAILABLE. THE PHYSICIAN SELECTED A DIFFERENT LENGTH GRAFT (20 X 20 X 82), WHICH PROVED TO BE TOO LONG AND RESULTED IN OCCLUSION OF THE LEFT COMMON ILIAC ARTERY. A FEMORAL-FEMORAL BYPASS WAS PREFORMED AND THE EVENT RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DUE TO DEVICE OVERSIZING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 6530235 ↗
• InjuryApr 17, 2017Separation Failure; Separation Failure

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT THE PRE-OPERATIVE RUPTURE OF AN AORTIC FISTULA. IT WAS NOTED THAT THE AORTO-GASTRIC FISTULA WAS SPITTING UP BLOOD AND THIS WAS A PALLIATIVE PROCEDURE TO PREVENT AORTIC RUPTURE. IT WAS REPORTED THAT, DURING THE INDEX PROCEDURE, THE PHYSICIAN ASKED THAT THE PATIENT NOT BE INTUBATED UNTIL AFTER FEMORAL ACCESS WAS GAINED. HOWEVER, ANESTHESIA DID NOT WAIT AND PRESSURE DROPPED UPON INTUBATION. PERCUTANEOUS ACCESS WAS GAINED AND A 12FR SHEATH WAS INSERTED. A RELIANT BALLOON WAS INSERTED AND INFLATED. THE PHYSICIAN STATED THAT THEY WOULD HAVE PREFERRED TO REMOVE THE BALLOON PRIOR TO DEPLOYMENT OF THE STENT GRAFT, BUT THOUGHT THAT THE PATIENT MAY BLEED OUT. THE STENT GRAFT WAS DEPLOYED AND PRESSURE STABILIZED. DURING REMOVAL OF THE BALLOON, THE BALLOON CAUGHT ON THE PROXIMAL EDGE OF THE STENT GRAFT AND PARTIALLY FOLDED IT BACK ON ITSELF. IMAGING WAS DONE AND DETERMINED THERE WAS NO DAMAGE. IT WAS NOTED THE STENT GRAFT WAS BALLOONED AND THE RUPTURE WAS SEALED, RESOLVING THE EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND IT WAS NOTED THAT THE PATIENT WOULD BE GOING HOME TO WAIT OUT THE FINAL

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 6499047 ↗

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-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-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-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