Endurant® II ETBF3620C145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994991058), received between Apr 12, 2017 and Apr 14, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL ANEURYSM ON (B)(6) 2019. VALIANT NAVION STENT GRAFTS WERE ALSO IMPLANTED IT WAS REPORTED APPROXIMATELY 3 MONTHS POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED A TYPE I ENDOLEAK FROM THE AORTIC NECK. A TYPE II ENDOLEAK FROM A PATENT LUMBAR VESSEL WAS ALSO OBSERVED.  PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK IS UNDETERMINED BUT NOTED THAT THE ENDOLEAK WAS OBSERVED IN THE VALIANT NAVION GRAFTS AND THE ENDURANT BIFURCATE. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14111456 ↗
• InjuryFeb 23, 2018Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.0CM THORACIC AORTIC ANEURYSM WITH A 1.5CM PROXIMAL AORTIC NECK AND A 3.0CM DIAMETER AORTA AT THE RENAL ARTERY. THERE WAS MILD VESSEL CALCIFICATION. IT WAS REPORTED THAT DURING A PATIENT FOLLOW UP, A TYPE IIIB ENDOLEAK WAS OBSERVED ON THE ANGIOGRAM AND THE FABRIC TEAR WAS NOTED TO BE JUST ABOVE THE FLOW DIVIDER OF THE MAIN BODY. THE PATIENT RECEIVED TREATMENT WITH AN AUI DEVICE IMPLANTED TO RELINE THE STENT GRAFT AS THE PHYSICIAN BELIEVED THIS TO BE THE ONLY WAY TO RESOLVE THE ENDOLEAK AND THERE WAS NO ENDOLEAK PRESENT UPON COMPLETION. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7291568 ↗
• InjuryAug 30, 2017Adverse 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 ABDOMINAL AORTIC ANEURYSM. THERE WAS A STENOSIS AND CALCIFICATION IN THE RIGHT COMMON FEMORAL ARTERY THAT WAS PRESENT PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT A DISSECTION OCCURRED IN THE RIGHT EXTERNAL ILIAC ARTERY AFTER THE PLACEMENT OF THE STENT GRAFT. THE DISSECTION WAS NOT FLOW LIMITING AT THE TIME OF IMPLANT SO THE PHYSICIAN DECIDED NOT TO TREAT THE DISSECTION. DURING THE PATIENT¿S RECOVERY, THEY LOST PULSE IN THEIR RIGHT LOWER EXTREMITY. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM AND THE PHYSICIAN PLACED SEVERAL STENTS FROM ANOTHER MANUFACTURER IN THE RIGHT COMMON ILIAC. THIS REPORTEDLY REPAIRED THE DISSECTION. AN 80% STENOSIS WAS ALSO TREATED IN THE RIGHT COMMON FEMORAL ARTERY WITH A BALLOON. THE RIGHT COMMON FEMORAL ALSO REPORTEDLY HAD A SEVERE CALCIUM DEPOSIT THAT WAS TREATED WITH A PATCH GRAFT. IT WAS NOTED THAT THE EVENT WAS RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE LOSS OF PULSE WAS DUE TO THE DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY AND DISEASED OUTFLOW. THE PHYSICIAN ALSO NOTED THAT THE STENT GRAFT DID NOT CAUSE THE LOSS OF PULSE IN THE RIGHT

  Patient problems: Vascular Dissection

  MAUDE report 6830365 ↗
• InjuryJun 7, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN. A CT WAS DONE AND SHOWED THERE WAS A IA ENDOLEAK AND RUPTURE. THE PHYSICIAN STATED WHEN THE STENT GRAFT WAS ORIGINALLY PLACED THEY USED APTUS AND PLACED SEVERAL ENDOANCHORS BECAUSE THE PATIENT HAD A SHORT AND LARGE DIAMETER AORTIC NECK. THE STENT GRAFT REMAINED WHERE IT WAS ORIGINALLY PLACED BUT DISEASE PROGRESSION MOVED UPWARD TO THE LEVEL OF THE RENAL ARTERIES. THE PHYSICIAN SNORKELED THE RIGHT RENAL AND EXTENDED USING AN ENDURANT CUFF THAT WAS PLACED JUST BELOW THE LEVEL OF THE SMA. THE PHYSICIAN STATED THE CAUSE OF THE EVENT WAS ANATOMY RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain; Rupture

  MAUDE report 6619774 ↗
• InjuryMay 3, 2017Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.2 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 10 MM IN LENGTH AND 27 MM IN DIAMETER AT THE RENAL ARTERIES. THERE WAS A SHARP CURVE/TURN IN THE DISTAL PART OF THE AORTIC NECK. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PHYSICIAN WAS MODELLING THE BIFURCATED STENT GRAFT WITH A RELIANT BALLOON AND INADVERTENTLY PULLED THE ENDURANT BIFURCATED STENT GRAFT DISTALLY. THE INACCURATE PLACEMENT OF THE ENDURANT BIFURCATED STENT GRAFT RESULTED IN A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT AORTIC CUFF AND THE EVENTS WERE RESOLVED. PER THE PHYSICIAN, THE EVENT WAS RELATED TO THE PATIENT¿S ANATOMY OF ANGULATION OF THE DISTAL AORTIC NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6542008 ↗
• InjuryApr 12, 2017Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: A CT WAS PERFORMED PRIOR TO THE PATIENT BEING DISCHARGED AND IT REVEALED THAT THE ENDOLEAK HAD RESOLVED.

  Patient problems: Injury

  MAUDE report 6487969 ↗

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-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