ENDURANT® ENBF3616C166ERecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994762375), received between Aug 16, 2017 and Jan 12, 2024 — classified as 1 death, 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2024Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED AAA. IT WAS REPORTED THE PATIENT PRESENTED TO ER, A CT WAS PERFORMED WHICH SHOWED BLOOD IN THE ABDOMEN DIAGNOSED AS A ANEURYSM RUPTURE AND ALSO AN ENDOLEAK. THE ENDOLEAK WAS THOUGHT TO BE TYPE II OR TYPE III ENDOLEAK. THE PATIENT WAS TRANSFERRED TO A SURGICAL HYBRID THEATRE TO PERFORMED A ANGIOGRAM. AFTER SEVERAL IMAGES AND VIEWPOINTS WERE COMPLETED, IT WAS THOUGHT THAT A POSSIBLE AREA OF CONTRAST WAS SEEN OUTSIDE THE STENT AND WITHIN THE ABDOMINAL SAC. THE AREA OF THE GRAFT WAS THE IPSILATERAL SIDE (RCIA) OF THE MAIN BODY BIFURCATE. THIS AREA WAS THEN RELINED WITH A 16X16X82 STENT GRAFT. FOLLOW-UP IMAGING WAS PERFORMED AND CONTRAST WAS NO LONGER FEEDING INTO THE SAC. OTHER IMAGING COULD NOT FIND ANY OTHER LEAKS. PER THE PHYSICIAN THE CAUSE OF THE SUSPECTED TYPE III ENDOLEAK COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL "SEQUELAE" WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 18501114 ↗
• DeathOct 26, 2022Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF AN UNKNOWN SIZE. IT WAS REPORTED APPROXIMATELY 10 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED TO THE HOSPITAL WITH SYMPTOMS OF ANEURYSM RUPTURE AND IT WAS DISCOVERED THE PATIENT HAD A LATE TYPE IB ENDOLEAK. THE PHYSICIAN IMPLANTED A LIMB EXTENSION ON THE PATIENT'S RIGHT ILIAC ARTERY. FOUR DAYS LATER, THE PATIENT PRESENTED EMERGENTLY AGAIN WITH RUPTURE SYMPTOMS AND AN LATE TYPE IB WAS DISCOVERED ON THE PATIENT'S LEFT ILIAC ARTERY. A 36 AUI STENT GRAFT WAS PLACED AND EXTENDED WITH A 16X13X156 LIMB. AFTER AUI WAS DEPLOYED WHILE REMOVING THE DELIVERY SYSTEM, NOSE CONE WAS CAUGHT ON SUPER RENAL STENTS. DELIVERY SYSTEM WAS REPOSITIONED AND REMOVED. GRAFTS WERE BALLOONED AND A DIAGNOSTIC ANGIOGRAPHY WAS PERFORMED AND SHOWED SATISFACTORY RESULTS. THE PHYSICIANS BEGAN TO PERFORM FEMORAL TO FEMORAL BYPASS SURGERY. THE PATIENT BEGAN CODING AND CPR WAS PERFORMED FOR 6 MINUTES WHEN TIME OF DEATH WAS CALLED. PER THE PHYSICIAN, THE CAUSE OF THE TYPE IB ENDOLEAK WAS DUE TO ILIAC DILATATION. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Cardiac Arrest; Rupture

  MAUDE report 15672088 ↗
• MalfunctionNov 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM .  IT WAS REPORTED DURING A FOLLOW-UP CT SCAN 10 YEARS LATER THAT THE SUPRARENAL STENT HAD SEPARATED FROM THE BIFURCATE STENT GRAFT, AND THE PATIENTS ANEURYSM HAS EXPANDED. THIS PATIENT WAS RECEIVING ANNUAL FOLLOW-UP SCANS AND THIS WAS THE FIRST SCAN WHERE THE ANEURYSM HAS EXPANDED. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 12795115 ↗
• InjuryJun 25, 2021Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 80 MM ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 9 1/2 POST PROCEDURE, A CT WAS PERFORMED , WHERE AN ENDOLEAK TYPE 1A WAS OBSERVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12065161 ↗
• MalfunctionNov 22, 2019Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED ON A FOLLOW UP CT APPROXIMATELY 8 YEARS AND TWO MONTHS LATER THAT A LARGE TYPE IA ENDOLEAK WAS IDENTIFIED AND DISRUPTION OF THE STENT GRAFT WHERE A SUPRA RENAL STENT HAS BECOME DETACHED FROM THE STENT GRAFT MATERIAL. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK AND DETACHMENT OF THE SUPRARENAL STENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9361586 ↗
• InjuryOct 1, 2019Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF 63 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAS TORTUROUS ANATOMY. IT WAS REPORTED THAT DURING A CT APPROXIMATELY 8 YEARS POST THE INDEX PROCEDURE SHOWED THE PATIENT HAD A TYPE IA ENDOLEAK. IT WAS ALSO REPORTED THAT THE PATIENT HAD A TYPE IB ENDOLEAK. IT WAS REPORTED THAT THE STENT GRAFT WAS RELINED WITH A NON-MDT DEVICE AND A RIGHT RENAL CHIMNEY PROCEDURE CARRIED OUT TO RESOLVE THE EVENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS BELIEVED TO BE MIGRATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9138772 ↗
• InjuryJul 23, 2019Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 6 YEARS 10 MONTHS POST IMPLANT, A FOLLOW UP CT IDENTIFIED THE BIFURCATE HAD MIGRATED DISTALLY WITH LOSS OF SEAL SEEN PROXIMALLY. THERE WAS NO TYPE IA ENDOLEAK NOTED. IT WAS NOTED THE PATIENT WAS ASYMPTOMATIC. THE FOLLOWING DAY, THE PHYSICIAN PERFORMED AN OPEN REPAIR AND THE DEVICE WAS EXPLANTED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 8815532 ↗
• MalfunctionJun 5, 2018Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT SCAN CARRIED OUT 7 YEARS LATER SHOWED THE BIFURCATED STENT GRAFT HAD MIGRATED ABOUT 1CM, THE ANEURYSM HAD INCREASED AND THE NECK DILATED UNTIL THE ANEURYSM STARTED JUST BELOW THE LOWEST RENAL. A LARGE TYPE IA ENDOLEAK WAS ALSO OBSERVED ON THE POSTERIOR ASPECT OF THE AORTA JUST BELOW THE LEFT RENAL. THE PHYSICIAN ATTRIBUTED THE CAUSE OF THE EVENT TO NECK DILATION CAUSING MIGRATION AND ENDOLEAK. THE EVENT HAS NOT RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Aneurysm; No Known Impact Or Consequence To Patient

  MAUDE report 7568426 ↗
• InjuryMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HELI-FX GUIDE, APPLIER AND ENDOANCHORS WERE USED PROPHYLACTICALLY IN THE ENDOVASCULAR TREATMENT OF THE PATIENT. AN ENDURANT STENT GRAFT SYSTEM WAS ALSO IMPLANTED ON THE SAME DATE. IT WAS REPORTED 2 DAYS POST THE INDEX PROCEDURE THAT THE PATIENT HAD AN ALTERED MENTAL STATUS THAT WAS NOTED TO BE RELATED TO THE INDEX PROCEDURE. THE HAD A PROLONGED HOSPITALIZATION AND THE EVENT RESOLVED WITH TREATMENT 8 DAYS POST THE INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND PATIENT WILL BE MONITORED.

  Patient problems: Confusion/ Disorientation; Injury

  MAUDE report 7556609 ↗
• InjuryOct 17, 2017Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 10 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE BIFURCATE WAS IMPLANTED FROM THE LEFT SIDE (16X24X93) LIMB IMPLANTED ON THE RIGHT SIDE. AN ENDURANT LIMB WAS IMPLANTED TO TREAT A RIGHT INTERNAL ILIAC ANEURYSM. THE RIGHT INTERNAL ILIAC ARTERY WAS COILED AND COVERED DURING THE PROCEDURE. THE PATIENT WAS LOST TO FOLLOW UP. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. A CT WAS PERFORMED AND A DISTAL TYPE I ENDOLEAK WAS OBSERVED IN THE LEFT ENDURANT IPSILATERAL STENT GRAFT LIMB. THE PATIENT WAS REFERRED TO THE ORIGINAL IMPLANTING PHYSICIAN AND AN INTERVENTION WAS PERFORMED. THE PHYSICIAN ELECTED TO EXTEND THE LEFT LIMB WITH ANOTHER ENDURANT STENT GRAFT LIMB AND IMPLANTED AN ENDURANT AORTIC CUFF. THE ENDOLEAK WAS RESOLVED AFTER THE INTERVENTION PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT ANATOMY OF CONTINUED AORTIC DILATATION DISTAL TO THE EXISTING STENT GRAFT. THE IPSILATERAL LIMB OF THE ENDURANT BIFURCATE EXTENDED APPROXIMATELY 3 CM INTO THE LEFT ILIAC ARTERY. THE PORTION OF THE ARTERY THAT WAS NOT COVERED BY THE STENT GRAFT HAD CO

  Patient problems: Injury

  MAUDE report 6953984 ↗
• InjuryAug 16, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A FOLLOW-UP SHOWED THAT THERE APPEARS TO BE A TYPE III SEPARATION ENDOLEAK ON THE RIGHT SIDE AND TOTAL OCCLUSION OF THE LEFT LIMB DUE TO A KINK. THE PHYSICIAN ELECTED TO IMPLANT TWO ENDURANT II STENT GRAFT LIMBS [16X16X93 AND 16X13X156] TO BRIDGE SEPARATION INTO THE EXTERNAL ILIAC ARTERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER COMPLICATIONS. THE PHYSICIAN BELIEVED THAT THE TYPE III SEPARATION ENDOLEAK WAS DUE TO ANEURYSM REMODELING. PER THE PHYSICIAN, THE CAUSE OF THE STENT GRAFT LIMB KINK WAS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6796581 ↗

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