Endurant® II ETTF3232C70ERecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994991508), received between Jan 5, 2017 and Aug 14, 2023 — classified as 1 death, 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 21, 2021Class IIOpen, Classified

   Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.

   Z-0657-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT CUFF AND AORTIC EXTENSION WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55MM AAA. IT WAS NOTED THAT AT IMPLANT THE DIAMETER OF THE AORTA AT THE RENAL ARTERY WAS 26MM, THE LENGTH OF THE PROXIMAL AORTIC NECK WAS 15MM, THE DEGREE OF ANGULATION WAS LESS THAN 60 DEGREES AND THERE WAS MILD VESSEL TORTUOSITY PRESENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE POST DEPLOYMENT OF ETCF3232C49E, THE DELIVERY SYSTEM WOULDN'T MOVE PROXIMALLY OR DISTALLY WHEN TRYING TO REMOVE IT. THE TWO STENT GRAFTS WERE EXPLANTED ON THE SAME DATE VIA OPEN ANEURYSM REPAIR. PER THE PHYSICIAN THE CAUSE OF THE REMOVAL DIFFICULTIES IS UNDETERMINED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17539817 ↗
• MalfunctionJan 3, 2023Leak/Splash; Device Damaged by Another Device; Leak/Splash; Device Damaged by Another Device

  AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AAA. ENDURANT CUFF EXTENSIONS WERE THEN 8 YEARS AND 5 MONTHS LATER.  IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW-UP , THE PHYSICIAN REPORTED THAT IT APPEARS THAT THE SECONDARY CUFF GRAFT (ENDURANT) THAT WAS IMPLANTED IN 2014 HAS CAUSED A TEAR IN THE ORIGINAL ANEURX GRAFT.  PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT DE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086860 ↗
• InjuryJul 27, 2022Leak/Splash; Leak/Splash

  AN ENDURANT IIS BIFURCATED STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED THE PATIENT PRESENTED TO THE HOSPITAL WITH ABDOMINAL PAIN. A CT TAKEN SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK.  THE NEXT DAY, A MODIFIED PROXIMAL ENDURANT CUFF WAS IMPLANTED TO TREAT THE TYPE IA ENDOLEAK. THE PHYSICIAN LASER FENESTRATED BOTH RENAL ARTERIES AND THE SMA. THE RENAL ARTERIES AND SMA WERE PRE-STENTED WITH BALLOON EXPANDABLE NON MDT STENTS AND LANDED THE GRAFT AT THE LEVEL OF THE CELIAC ARTERY. COVERED STENTS WERE IMPLANTED IN EACH VESSEL. THE FINAL ANGIOGRAM SHOWED A SMALL TYPE I ENDOLEAK. A NON-MDT CUFF WAS LANDED TO ADD ADDITIONAL OVERLAP. AFTER THE CUFF PLACEMENT BALLOONING WAS PERFORMED AND A FINAL ANGIOGRAM SHOWED THE LEAK HAD RESOLVED WITH A FAINT BLUSH. IT WAS CONFIRMED THAT THE ENDURANT CUFF CONTAINED THE FENESTRATIONS AND AFTER THIS GRAFT WAS IMPLANTED AN UNKNOWN ENDOLEAK SUSPECTED TO BE EITHER A TYPE I ENDOLEAK FROM THE TOP, A FENESTRATION ENDOLEAK OR A TYPE IIIA DUE TO INSUFFICIENT OVERLAP. THE NON MDT CUFF WAS THEN PLACED TO RULE OUT NOT ENOUGH OVERLAP. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT'S

  Patient problems: Insufficient Information

  MAUDE report 15111943 ↗
• MalfunctionJun 15, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II AORTIC EXTENSION STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF AN UNKNOWN SIZE . BILATERAL RENAL SNORKELS WERE ALSO IMPLANTED. THE PATIENT HAD PRESENTED WITH DISEASE PROGRESSION OF THE PATIENTS AORTA SUPERIOR TO A PREVIOUS AORTIC REPAIR. IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP CT WHERE IT WAS NOTED THE TUBE GRAFT HAS LOST APPOSITION RESULTING IN A TYPE IA ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS AS A RESULT OF DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14692742 ↗
• InjurySep 21, 2021Device Damaged by Another Device; Device Damaged by Another Device

  AN ENDURANT II STENT GRAFT CUFF WAS IMPLANTED IN THE PATIENT ALONG WITH BILATERAL RENAL SNORKELING FOR THE TREATMENT OF A TYPE 1A ENDOLEAK OF A PREVIOUSLY IMPLANTED EVAR GRAFT. IT WAS REPORTED THAT THE ETTF3232C70E ENDURANT CUFF WAS DEPLOYED AND DELIVERY SYSTEM REMOVED WITHOUT INCIDENCE. UPON REMOVAL OF THE DELIVERY SYSTEM BALLOON FROM THE LEFT RENAL ARTERY, THE PHYSICIAN COMMENTED THAT THE BALLOON APPEARED TO CAUGHT ON AN ANCHOR PIN OF THE SUPRARENAL STENT. IT WAS STATED THAT THE PHYSICIAN THEN APPLIED A STRONG PULLING FORCE ON THAT DELIVERY SYSTEM AND THE DELIVERY SYSTEM CAME OUT WHILE ANGIOGRAPHY EVIDENCED THAT THE BALLOON AND INFLATION LUMEN REMAINED IN THE BODY, WITH THE BALLOON MARKERS STILL CLOSE TO THE SUPRARENAL STENT. A NON-MEDTRONIC 28.5 X 28.5X33MM CUFF WAS DEPLOYED ABOVE THE CELIAC IN THE DTA OVER PART OF THE BALLOON AND INFLATION LUMEN. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS THAT THE RENAL STENT BALLOON CAME IN CONTACT WITH SUPRARENAL ANCHOR PIN. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: Insufficient Information

  MAUDE report 12506665 ↗
• InjurySep 1, 2020Device Damaged by Another Device; Device Damaged by Another Device

  AN ENDURANT II AORTIC EXTENSION STENT GRAFT WAS IMPLANTED AS PART OF A BILATERAL RENAL SNORKEL TECHNIQUE IN THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THAT ONE OF THE RENAL ARTERIES WAS PERFORATED AND THEN HAD TO BE EMBOLIZED. IT WAS BELIEVED THAT THE PERFORATION OCCURRED WHEN THE PHYSICIAN WAS MANIPULATING A NON -MDT SHEATH INTO THE RENAL ARTERY WITHOUT ADEQUATE SUPPORT OF GUIDEWIRE. IT WAS REPORTED WHEN THE NON MDT INTRODUCER SHEATH WAS ADVANCED DOWNWARD IN AN ATTEMPT TO RE-CANNULATE THE RENAL ARTERY, IT GOT STUCK ON ONE OF THE SUPRA-RENAL STENTS. THE STENT WAS ENGAGED WITH THE INNER WALL OF SHEATH, MULTIPLE ATTEMPTS WERE MADE TO REMOVE IT, BUT IT COULD NOT BE REMOVED WITHOUT DISLODGING THE STENT GRAFT. THEREFORE IT WAS CUT AT THE PROXIMAL VALVE AT THE LEVEL OF LSA AND WAS LEFT FLOATING IN PATIENTS LSA AND AORTA. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS USER ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation of Vessels

  MAUDE report 10475982 ↗
• MalfunctionDec 3, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 10 ENDOANCHORS WERE IMPLANTED FOR THE TREATMENT OF A TYPE 1A ENDOLEAK WHICH OCCURRED APPROXIMATELY ONE MONTH EARLIER. HOWEVER, THE ENDOLEAK DID NOT RESOLVE. A CHEVAR PROCEDURE WAS THEN CARRIED OUT ON BOTH RENAL ARTERIES AND AN ENDURANT AORTIC CUFF WAS USED TO EXTEND PROXIMALLY TO THE SMA TO TREAT THE ENDOLEAK. IT WAS REPORTED THAT THE ENDOLEAK WAS MUCH IMPROVED BUT NOT COMPLETELY RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS ANATOMY RELATED DUE TO AN ANGULATED INFRARENAL NECK. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9400775 ↗
• InjuryJun 27, 2019Malposition of Device; Malposition of Device

  AN ANUERX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. BOTH THE YRI RX16115 AND YRECX1655 STENT GRAFT LIMBS WERE PLACED ON THE CONTRALATERAL SIDE. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY FIFTEEN YEARS LATER AND A CT STUDY SHOWED MIGRATION OF THE BIFURCATED STENT GRAFT IN TO THE ANEURYSM SAC AND A TYPE IA ENDOLEAK. THE CURRENT ANEURYSM SIZE IS A 75 MM. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. A SECONDARY INTERVENTION PROCEDURE WAS CARRIED OUT THE FOLLOWING DAY AND TWO ENDURANT AORTIC EXTENSIONS WERE IMPLANTED. IT WAS REPORTED THAT THE AORTIC EXTENSION ETTF3232C70E WAS INADVERTENTLY DEPLOYED BELOW THE FLOW DIVIDER AND SUBSEQUENTLY OBSTRUCTED FLOW DOWN THE CONTRALATERAL LIMB. A FEM-FEM BYPASS WAS CARRIED OUT TO RESTORE FLOW TO THE CONTRALATERAL LIMB. AS PER THE PHYSICIAN, ONE OF THE CONTRIBUTING FACTORS WAS THAT THE C-ARM WAS UNABLE TO "TILT" OR "ANGLE" INTO THE CRANIAL POSITION AS A RESULT OF THE BASE ARM HITTING THE BOTTOM OF THE BASE STAND OF THE OR TABLE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8739131 ↗
• DeathJun 15, 2017Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED. THE PATIENT EXPERIENCED CARDIAC ARREST DURING REMOVAL OF THE VASCULAR ACCESS SHEATHS THAT HAD BEEN PLACED IN THE FEMORAL ARTERIES AND WERE BEING REMOVED UPON FINAL CLOSURE.

  Patient problems: Death

  MAUDE report 6644428 ↗
• InjuryJan 5, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 63 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS LOST TO FOLLOW UP. TWO ENDURANT CUFFS WERE IMPLANTED DURING INTERVENTION. IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW UP AND IT WAS DISCOVERED THAT THE ANEURX STENT GRAFT HAD MIGRATED AND HAD A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT A 32X32X70 ENDURANT AORTIC CUFF, HOWEVER WHILE ATTEMPTING TO RECAPTURE THE TIP OF THE DELIVERY SYSTEM AFTER DEPLOYMENT OF THE AORTIC CUFF THE PHYSICIAN UNINTENTIONALLY PUSHED THE GRAFT COVER UP AND CAUSED THE DISTAL END OF THE CUFF TO PROLAPSE PROXIMALLY. THE PHYSICIAN THEN IMPLANTED AN ADDITIONAL 32X32X49 ENDURANT AORTIC CUFF BUT WAS UNABLE TO OBTAIN SUFFICIENT OVERLAP FOR A SEAL. THE PHYSICIAN ATTRIBUTED THE LACK OF OVERLAP TO THE REMOVAL ISSUES DUE TO THE PATIENT'S ANATOMY AND THE SEVERELY ANGLED NECK (ANTERIOR AND POSTERIOR) WHERE THE TAPERED TIP WAS DRAGGING AGAINST THE FIRST CUFF. IN ADDITION THE PROXIMAL PORTION OF THE ANEURX BIFURCATED STENT GRAFT WAS UNDER 3CM IN LENGTH AND WAS BENT DUE TO THE ANGLE OF THE NECK MAKING THE SEATING FOR THE SECOND CUFF VERY DIFFICULT

  Patient problems: Injury

  MAUDE report 6227086 ↗
• InjuryJan 5, 2017Difficult to Remove; Malposition of Device; Difficult to Remove; Malposition of Device

  AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 63 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS LOST TO FOLLOW UP. TWO ENDURANT CUFFS WERE IMPLANTED DURING INTERVENTION. IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW UP AND IT WAS DISCOVERED THAT THE ANEURX STENT GRAFT HAD MIGRATED AND HAD A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT A 32X32X70 ENDURANT AORTIC CUFF, HOWEVER WHILE ATTEMPTING TO RECAPTURE THE TIP OF THE DELIVERY SYSTEM AFTER DEPLOYMENT OF THE AORTIC CUFF THE PHYSICIAN UNINTENTIONALLY PUSHED THE GRAFT COVER UP AND CAUSED THE DISTAL END OF THE CUFF TO PROLAPSE PROXIMALLY. THE PHYSICIAN THEN IMPLANTED AN ADDITIONAL 32X32X49 ENDURANT AORTIC CUFF BUT WAS UNABLE TO OBTAIN SUFFICIENT OVERLAP FOR A SEAL. THE PHYSICIAN ATTRIBUTED THE LACK OF OVERLAP TO THE REMOVAL ISSUES DUE TO THE PATIENT'S ANATOMY AND THE SEVERELY ANGLED NECK (ANTERIOR AND POSTERIOR) WHERE THE TAPERED TIP WAS DRAGGING AGAINST THE FIRST CUFF. IN ADDITION, THE PROXIMAL PORTION OF THE ANEURX BIFURCATED STENT GRAFT WAS UNDER 3CM IN LENGTH AND WAS BENT DUE TO THE ANGLE OF THE NECK MAKING THE SEATING FOR THE SECOND CUFF VERY DIFFICUL

  Patient problems: Injury

  MAUDE report 6227084 ↗

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-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-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-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