Endurant® II ETLW1616C156E (UDI 00613994991607)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994991607), received between Jan 16, 2018 and Feb 28, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (4 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.

• MalfunctionFeb 28, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60.6MM AAA. THE MAIN BODY WAS PLACED IP SILATERAL RIGHT AND EXTENDED WITH A 13X13X82 LIMB EXTENSION. A 16X16X156 ENDURANT WAS IMPLANTED AS THE CONTRALATERAL LIMB.  A CT WAS PERFORMED WHERE TYPE IA AND TYPE IB ENDOLEAKS WERE NOTED. THE NECK HAS DILATED TO GREATER THAN THE GRAFT SIZE PROXIMALLY AND BILATERALLY DISTALLY. AN ANGIOGRAPHY WAS ALSO PERFORMED. THE PATIENT IS ASYMPTOMATIC.  PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS IS NATURAL DISEASE PROGRESSION.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451305 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY TO ER WITH A RUPTURED AAA. THE CT DID NOT SHOW AN ENDOLEAK BUT A INTERMITTENT TYPE IA ENDOLEAK WAS CONSIDERED. AAA MEASURES WERE 54X49MM WITH A SIGNIFICANT AMOUNT OF BLOOD IN THE RETROPERITONEUM. THE DEVICE WAS PLACED AT THE LOWEST LEFT RENAL ARTERY THEREFORE A CUFF WAS NOT ADDED. NO TYPE IA ENDOLEAK COULD BE SEEN ON ANGIOGRAM HOWEVER THE PHYSICIAN DECIDED TO IMPLANT 10 ENDOANCHORS. THERE WAS NO TYPE IB EITHER HOWEVER THE RIGHT LIMB HAD SEAL FOR 3CM BUT THERE WAS STILL 3CM TO THE HYPO AND IT DECIDED TO EXTENDED THE LIMB. IT WAS REPORTED THERE WAS ADEQUATE SEAL BUT THE PHYSICIAN WANTED TO MAXIMIZE COVERAGE. AFTER THE GROIN WAS CLOSED, THE PATIENT LOST THE PULSE IN HIS RIGHT GROIN AND LEG. THROMBECTOMY WAS ATTEMPTED SEVERAL TIMES WITHOUT ANY CLOT BEING REMOVED. PATIENT HAD DOPPLER SIGNALS IN BOTH FEET AT THE END OF THE CASE AND AS OF THIS MORNING. PER PHYSICIAN, THE PATIENT IS DOING WELL AND CONTINUES TO HAVE PULSES IN BOTH FEET. IT WAS REPORTED THE PATIENT RETURNED TO OPERATING ROOM AROUND A WEEK LATER FOR ANGIOGRAM AND CT SCAN SHOWED NEW THROM

  Patient problems: Obstruction/Occlusion; Rupture

  MAUDE report 14081774 ↗
• InjuryDec 4, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 92MM RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS NOTED TO HAVE TORTUOUS VESSELS AND MILD CALCIFICATION. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY 5.5 YEARS LATER WITH ABDOMINAL PAIN AND CTA REVEALED EXPANSION OF THE AAA AND A TYPE IB ENDOLEAK AT THE PATIENTS RIGHT ILIAC LIMB. THE PATIENT HAD INTERVENTION ON THE SAME DATE WITH THE IMPLANTATION OF AN AORTIC CUFF TO THE LEVEL OF THE RENALS TO GAIN ADDITIONAL SEAL AND ALSO PLACES A LIMB IN THE RIGHT EIA WHICH WAS BALLOONED WITH A RELIANT AND A PTA BALLOON. POST ANGIOGRAM SHOWED RESOLUTION OF THE ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO AORTIC REMODELING AND SUBSEQUENT LOSS OF SEAL OF THE RIGHT ILIAC LIMB. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9409381 ↗
• InjuryApr 18, 2018Leak/Splash; Leak/Splash

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 100MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN APPROXIMATELY 3.5 YEARS POST THE INDEX PROCEDURE. A TYPE 1B ENDOLEAK WAS IDENTIFIED IN THE PATIENT. THE PHYSICIAN TREATED THE PATIENT BY EMBOLIZING THE LEFT INTERNAL ILIAC AND THEN PLACING A VBX STENT SEALING FROM THE STENT GRAFT INTO THE LEFT EXTERNAL ILIAC. THE PHYSICIAN ATTRIBUTED THE CAUSE OF THE EVENT TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain; Injury

  MAUDE report 7439257 ↗
• InjuryMar 19, 2018Occlusion Within Device; Occlusion Within Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACOABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT REPORTED FOR FOLLOW UP EXAM APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE WHERE IT WAS DISCOVERED THAT A THROMBUS HAD DEVELOPED IN THE CONTRALATERAL LIMB OF THE MODIFIED STENT GRAFT. THIS WAS TREATED WITH THROMBOLYTIC THERAPY AND WAS RELINED WITH AN ENDURANT II LIMB. THE EVENT WAS RESOLVED AFTER THIS. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 7348462 ↗
• InjuryJan 16, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 78 MM DIAMETER RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN APPROXIMATELY 2 YEARS AND 9 MONTHS POST THE INDEX PROCEDURE. CT EXAM SHOWED A RUPTURED ANEURYSM AND IT WAS NOTED THAT THE LIMB THAT EXTENDED INTO THE RIGHT COMMON ILIAC ARTERY HAD PULLED BACK INTO THE ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN RESOLVED THE ENDOLEAK INTO THE RUPTURE WITH THE IMPLANTATION OF A 16 X 10 X 124 MM STENT GRAFT LIMB INTO THE RIGHT EXTERNAL ILIAC ARTERY. AS PER THE PHYSICIAN, 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 7192818 ↗

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