Endurant® II ETEW1313C82ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994991386), received between Jan 13, 2017 and Oct 6, 2023 — classified as 3 deaths, 4 injuries.

The most frequently reported specific device problem is “Leak/Splash” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2023Malposition of Device; Malposition of Device

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE TREATMENT OF A 155MM TYPE B AORTIC DISSECTION.  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, FEMORAL ACCESS WAS GAINED BILATERALLY. WIRES WERE PLACED PROPERLY FOLLOWED BY A PIGTAIL MARKER ON THE RIGHT SIDE AND IVUS ON THE LEFT SIDE. THE IVUS USED SHOWED THE LOCATION WAS  IN THE TRUE LUMEN. TRUE LUMEN VERIFICATION WAS ESTABLISHED BASED OFF THE KNOWN VISCERAL VESSELS COMING OFF TRUE LUMEN AND THE AORTIC ARCH VESSELS. MEASUREMENTS WERE TAKEN USING IVUS FOR CONFIRMATION ALONG WITH THE CT SCAN FOR PROPER GRAFT SELECTION . ONCE THE TRUE LUMEN WAS ESTABLISHED A STIFF WIRE WAS ADVANCED INTO THE AORTA PROPERLY AND PROPERLY SEATED AROUND THE ARCH. ONCE THE GUIDEWIRE WAS ESTABLISHED, AN IVUS WAS USED TO MONITOR ALL THE WAY DOWN UNTIL IT EXITED THE PATIENT.  AN AORTOGRAM WITH THE PIG TAIL WAS THEN USED TO NOTE A FOCAL FENESTRATION CAUSING THE DISSECTION. THE 42X42X200 VALIANT CAPTIVIA AORTIC GRAFT WAS THEN PLACED ON THE LEFT WIRE AND  ADVANCED THROUGH THE LEFT FEMORAL ACCESS. ACCESS WAS TIGHT THEREFORE THE DEVICE WAS PULLED OUT AND THE ACCESS WAS PREDILATED WITH A  20FR SHEATH. THE SHEATH WAS REMOVED AND THE VALIANT CAPTIVIA WAS ADVANCED

  Patient problems: Insufficient Information

  MAUDE report 17885114 ↗
• DeathMar 22, 2021Malposition of Device; Malposition of Device

  ENDURANT STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR THE EMERGENCY ENDOVASCULAR TREATMENT OF A RUPTURED ILIAC ARTERY. IT WAS REPORTED DURING THE PROCEDURE ETEW1313C82E AND ETLW1616C93E WERE PLACED QUICKLY IN THE ARTERY YET THE PRESSURE CONTINUED TO DROP. THE ABDOMEN WAS THEN OPENED UP AND IT WAS NOTED THE LIMB WAS NOT PROPERLY IN THE ARTERY AS THE ARTERY WAS DESTROYED. IT WAS REPORTED THE CAUSE OF THE LIMB NOT BEING CORRECTLY PLACED WAS DUE TO SMALL ACCESS VESSELS. IT WAS REPORTED THE PATIENT DIED ONE DAY POST PROCEDURE. AS PER THE PHYSICIAN, THE DEATH WAS NOT RELATED TO THE MEDTRONIC DEVICES.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 11543195 ↗
• InjurySep 3, 2020Leak/Splash; Leak/Splash

  AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY OVER FIVE YEARS LATER, A DISTAL TYPE IB ENDOLEAK ON ETEW1313C82E HAD CAUSED A ANEURYSM RUPTURE. INTERVENTION WAS PERFORMED AND A LIMB EXTENSION WAS IMPLANTED. THIS RESOLVED THE ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND NOTED THE DISEASE PROGRESSION ON THE COMMON ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 10487209 ↗
• InjuryDec 13, 2019Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 42MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY 6 YEARS AND 4 MONTHS POST IMPLANT WITH INCREASING BACK AND FLANK PAIN. CTA SHOWED A TYPE IA AND TYPE IB ENDOLEAK WITH SIGNIFICANT DILATION OF BOTH COMMON ILIAC ARTERY'S (LEFT CIA>70MM) AND EXPANSION OF THE PROXIMAL AORTIC NECK. IT WAS CONFIRMED THAT THE BIFURCATE STENT GRAFT WAS NOT INVOLVED IN THE TYPE IB ENDOLEAK. THE LEFT COMMON ILIAC LIMB APPEARED TO BE ¿FLOATING¿ IN THE COMMON ILIAC SPACE. TREATMENT WAS PERFORMED THE NEXT DAY AND IT WAS DECIDED TO EXTEND BILATERALLY IN THE EIA'S ALONG WITH COIL EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY. BILATERAL CHIMNEY GRAPHS WERE ALSO PLACED IN BOTH RENALS TO FACILITATE EXTENSION OF THE COVERAGE TO THE LEVEL OF THE SMA. THE ENDOLEAKS WERE RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO LOSS OF THE PATIENT TO FOLLOW UP, LOSS OF APPOSITION OF THE STENT GRAFT, DUE TO THE DILATION OF THE PATIENT'S VESSELS, THAT LEAD TO THE ENDOLEAKS WAS NOT SEEN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9465119 ↗
• DeathApr 13, 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 A 5.1 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM AND A 2.5 CM IN DIAMETER RIGHT ILIAC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS SEVERE CALCIFICATION IN THE VESSELS. IT WAS REPORTED THAT THE RIGHT AND LEFT COMMON FEMORAL ARTERIES WERE EXPOSED AND CONTROLLED SECURED WITH A VESSEL LOOPS. USING AN 18GAUGE NEEDLE TO GAIN ACCESS INTO THE RIGHT COMMON FEMORAL VASCULAR ANATOMY. ANOTHER MANUFACTURER¿S 7FR SHEATH WAS PLACED AND A GLIDE WIRE WITH ANOTHER MANUFACTURER¿S CATHETER WERE ADVANCED TO THE SUPRARENAL AORTA. THE GLIDE WIRE WAS EXCHANGED FOR ANOTHER GUIDE WIRE. THE CATHETER AND SHEATH WERE REMOVED AND A SENTRANT 12FR SHEATH WAS ADVANCED TO THE EXTERNAL ARTERY. THE SENTRANT 12FR SHEATH WAS UNABLE TO BE ADVANCED INTO THE RIGHT COMMON ILIAC DUE TO THE CALCIUM. ANOTHER MANUFACTURER¿S DILATOR WAS USED TO DILATE THE COMMON AND EXTERNAL ILIAC ARTERIES. POST DILATATION THE PHYSICIAN ATTEMPTED TO ADVANCE THE SENTRANT 12FR SHEATH AGAIN WITHOUT SUCCESS. THE PHYSICIAN ELECTED TO ACCESS THE LEFT COMMON FEMORAL ARTERY. A 18GA NEEDLE WAS USED ALONG WITH SENTRANT 16FR SHEATH WAS USED TO GAIN ACCESS INTO THE

  Patient problems: Blood Loss; Death; Myocardial Infarction

  MAUDE report 6491972 ↗
• DeathApr 13, 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 A 5.1 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM AND A 2.5 CM IN DIAMETER RIGHT ILIAC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS SEVERE CALCIFICATION IN THE VESSELS. IT WAS REPORTED THAT THE RIGHT AND LEFT COMMON FEMORAL ARTERIES WERE EXPOSED AND CONTROLLED SECURED WITH A VESSEL LOOPS. USING AN 18GAUGE NEEDLE TO GAIN ACCESS INTO THE RIGHT COMMON FEMORAL VASCULAR ANATOMY. ANOTHER MANUFACTURER¿S 7FR SHEATH WAS PLACED AND A GLIDE WIRE WITH ANOTHER MANUFACTURER¿S CATHETER WERE ADVANCED TO THE SUPRARENAL AORTA. THE GLIDE WIRE WAS EXCHANGED FOR ANOTHER GUIDE WIRE. THE CATHETER AND SHEATH WERE REMOVED AND A SENTRANT 12FR SHEATH WAS ADVANCED TO THE EXTERNAL ARTERY. THE SENTRANT 12FR SHEATH WAS UNABLE TO BE ADVANCED INTO THE RIGHT COMMON ILIAC DUE TO THE CALCIUM. ANOTHER MANUFACTURER¿S DILATOR WAS USED TO DILATE THE COMMON AND EXTERNAL ILIAC ARTERIES. POST DILATATION THE PHYSICIAN ATTEMPTED TO ADVANCE THE SENTRANT 12FR SHEATH AGAIN WITHOUT SUCCESS. THE PHYSICIAN ELECTED TO ACCESS THE LEFT COMMON FEMORAL ARTERY. A 18GA NEEDLE WAS USED ALONG WITH SENTRANT 16FR SHEATH WAS USED TO GAIN ACCESS INTO THE

  Patient problems: Blood Loss; Death; Myocardial Infarction

  MAUDE report 6491961 ↗
• InjuryJan 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A GREATER THAN 5.0CM ABDOMINAL AORTIC ANEURYSM. MILD PROXIMAL NECK CALCIFICATION AND MILD BILATERAL ILIAC CALCIFICATION WAS NOTED. IT WAS REPORTED THAT THE STENT GRAFT WAS DEPLOYED AND THERE WAS GREAT FILLING OF THE LEFT RENAL ARTERY; HOWEVER, THE ANGIOGRAM APPEARED TO SHOW THAT THE FABRIC OF THE GRAFT WAS PARTIALLY COVERING THE LEFT RENAL ARTERY. ANOTHER MANUFACTURER¿S STENT WAS PLACED IN THE LEFT RENAL. IT WAS ALSO NOTED THAT THERE WAS NARROWING OF THE RIGHT COMMON ILIAC ARTERY; SO THE PHYSICIAN PLACED ANOTHER MANUFACTURES STENT THERE AS WELL. IT WAS REPORTED THAT THE EVENT WAS RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 6251173 ↗

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