Endurant® II ETBF3620C166ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994991065), received between Apr 26, 2017 and Jul 21, 2022 — classified as 1 death, 6 injuries.

The most frequently reported specific device problem is “Leak/Splash” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2022Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 8 YEARS POST THE INDEX PROCEDURE FOLLOW UP IDENTIFIED A TYPE IA WITH MIGRATION WAS OBSERVED. THE PATIENT WAS BROUGHT TO OR TO HAVE EXTENSION CUFF AND SNORKEL STENT IN LOWER LEFT RENAL. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO THE PATIENTS ANATOMY AS A RESULT OF A LARGE NECK, AS THE NECK HAD DILATED OVER TIME. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15073474 ↗
• InjuryJun 15, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATED STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE THE PATIENT RETURNED FOR A FOLLOW-UP CT. A TYPE IB ENDOLEAK AND OCCLUDED RIGHT ILIAC LIMB WAS OBSERVED.  AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS AS A RESULT OF DISEASE PROGRESSION.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14692880 ↗
• DeathNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED NOTIFICATION VIA TECHNICAL SERVICES IN WHICH A PATIENT REPRESENTATIVE WANTED TO RETURN A MONITOR. IT WAS REPORTED THAT THE PATIENT'S REPRESENTATIVE FATHER PASSED AND HE HAD MEDTRONIC STENT GRAFTS IMPLANTED. IT WAS STATED THAT PATIENT PASSED HOWEVER DID NOT MENTION THE STENT GRAFT AS THE CAUSE OF DEATH. IT WAS NOTED THAT A ENDURANT II STENT GRAFT SYSTEM HAD BEEN IMPLANTED ON THE (B)(6) 2016.

  Patient problems: Insufficient Information

  MAUDE report 12750388 ↗
• InjuryDec 2, 2020Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY OVER A YEAR LATER, WITH A RUPTURED ANEURYSM CONFIRMED ON CT AND ALSO A POSSIBLE TYPE IA ENDOLEAK. INTERVENTION WAS PERFORMED, AN ENDURANT AORTIC CUFF WAS IMPLANTED DISTAL TO THE LEFT RENAL ARTERY AND COVERING THE RIGHT RENAL ARTERY. ENDOANCHORS WERE ALSO IMPLANTED TO AID THE FIXATION OF THIS GRAFT TO THE AORTIC WALL. THE RIGHT ANEURYSMAL HYPOGASTRIC ARTERY WAS SELECTED AND EMBOLIZED AND THE RIGHT LIMB WAS EXTENDED WITH A 16 X 10 X 124 TO THE RIGHT EXTERNAL ILIAC ARTERY. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS THAT DURING THE INDEX PROCEDURE, THE BIFURCATE STENT GRAFT WAS PLACED LOW WHICH LED TO AN INADEQUATE PROXIMAL LANDING ZONE WHICH TURNED INTO THE LATE TYPE IA ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 10935139 ↗
• InjuryJul 4, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 77MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A RETURN FOLLOW UP APPROXIMATELY 2.5 YEARS POST INDEX PROCEDURE, THE PHYSICIAN INDICATED A TYPE IA ENDOLEAK WAS PRESENT. THE PATIENT RECEIVED TREATMENT WITH THE IMPLANTATION OF HELI-FX ENDOANCHORS. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7662436 ↗
• InjuryMar 29, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 3.5 YEARS POST INDEX PROCEDURE A CT WAS PERFORMED REVEALING A A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO PERFORM SURGERY TO SOLVE THE ENDOLEAK. AFTER ANGIOGRAM IT WAS DETERMINED THAT THERE WAS 7CM FROM THE GRAFT BIFURCATION TO THE SMA AND THE TYPE IA ENDOLEAK. AS THE PATIENT WAS ON DIALYSIS, THE PHYSICIAN WAS ABLE TO COVER BOTH RENAL ARTERIES WITH A 36X36X70 AORTIC CUFF WHICH WAS PLACED INSIDE THE PREVIOUS IMPLANTED BIFURCATE AT THE LEVEL OF THE SMA. THE CUFF WAS THEN BALLOONED USING A RELIANT BALLOON; HOWEVER, AFTER ANGIOGRAM THE ENDOLEAK WAS STILL VISIBLE. THE PHYSICIAN DECIDED THEN TO PLACE ENDOANCHORS INSIDE THE CUFF BUT AFTER PLACING 3 ENDOANCHORS THE HELI-FX APPLIER FROZE AND WOULDN'T WORK. A NEW HELI-FX APPLIER WAS OPENED AND A FURTHER 16 ENDOANCHORS WERE PLACED. AFTER THIS THE ENDOLEAK WAS RESOLVED AND THE CASE WAS COMPLETED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO A LARGE REVERSE CONE NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7380644 ↗
• InjuryApr 26, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 5.7 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE BILATERAL COMMON FEMORAL ARTERIES WERE EXPOSED AND CONTROLLED WITH CEASE LOOPS. THE ARTERIES WERE ACCESS WITH AN 18GA NEEDLE AND 9 FR SHEATHS. A GUIDE WIRE WAS PLACED IN THE DESCENDING THORACIC AORTA DISTAL TO THE LSA FROM THE RIGHT COMMON FEMORAL. FROM THE LEFT A PIG TAIL CATHETER WAS PLACE TO THE LEVEL OF L1-L2 DISC SPACE. AN AORTOGRAM WAS PERFORM AND AN ENDURANT BIFURCATED STENT GRAFT IMPLANTED DISTAL TO THE LEFT RENAL ARTERY AND EXTENDED PROXIMAL TO THE RIGHT HYPOGASTRIC ARTERY THE DELIVERY SYSTEM WAS THEN REMARRIED. AT THIS POINT A GLIDE WIRE WAS USED TO STRAIGHTEN THE PIG TAIL OUT AND THE GLIDE WIRE ALONG WITH THE MARKER PIG TAIL CATHETER WAS PULLED DISTAL TO THE GATE. THE PIGTAIL WAS REFORMED AND ADVANCED INTO THE GATE WITHOUT ISSUE. THE PIG TAIL CATHETER WAS SPUN TO CONFIRM GATE CANNULATION. A GUIDEWIRE WAS PLACED INTO THE MARKER PIG TAIL CATHETER AND ADVANCE TO THE DESCENDING THORACIC AORTA DISTAL TO THE LSA. A MARKER ON THE CATHETER WAS LINED UP WITH THE FLOW DIVIDER MARKER OF THE ENDURANT BIFURCATE. THE C-ARM WAS PLAC

  Patient problems: Injury

  MAUDE report 6523045 ↗

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-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-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-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