Endurant® II ETEW1010C82ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994991379), received between Jun 28, 2018 and Nov 16, 2023 — classified as 2 deaths, 3 injuries, 1 malfunction.

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 16, 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.

• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A DESCENDING THORACIC AORTIC IMH WITH A HEMOTHORAX. THE 34X30X150 WAS IMPLANTED JUST DISTAL TO LEFT SUBCLAVIAN ARTERY WHILE THE OTHER VALIANT CAPTIVIA WAS IMPLANTED JUST PROXIMAL TO THE CELIAC WITH GOOD OVERLAP. 1 YEAR AND 10 MONTHS LATER , THE PATIENT WAS DIAGNOSED WITH A TYPE B AORTIC DISSECTION WHICH HAD EXTENDED PROXIMALLY INTO THORACO-ABDOMINAL AORTA, AND DISTALLY INTO ILIAC ARTERIES. THE PATIENT HAD PRESENTED WITH LLE LIMB ISCHEMIA SECONDARY TO THE DISSECTION AS WELL AS CHEST AND BACK PAIN. THEREFORE AS TREATMENT A 34X34X97 VALIANT NAVION STENT GRAFT WAS IMPLANTED OVERLAPPING THE PROXIMAL CAPTIVIA STENT GRAFT. AN ENDURANT II AUI WAS IMPLANTED AND EXTENDED WITH TWO ENDURANT LIMBS INTO THE RIGHT ILIAC ARTERY. THREE YEARS AND NINE MONTHS LATER, THE PATIENT PRESENTED EMERGENTLY WITH ALTERED MENTAL STATUS. A CT OF THE HEAD AND NECK WAS PERFORMED AS WELL AS A CT OF THE CHEST/ABDOMEN WITH CONTRAST. THE HEAD/NECK CT SHOWED THE FOLLOWING; THERE IS CONTRAST OPACIFICATION EXTENDING INTO THE INTRAMURAL HEMATOMA ON POSTCONTRAST IMAGES AT THE LEVEL OF THE DISTAL ASCENDING AORTA. THIS AREA HAS PROGRESSIVELY FI

  Patient problems: Ischemia; Pain; Vascular Dissection

  MAUDE report 18150359 ↗
• DeathNov 18, 2022Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA AND ENDURANT STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 58MM THORACIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, VAMF(B)(4) WAS ADVANCED TO THE THORACIC AORTA WITH SOME RESISTANCE BUT PLACED SUCCESSFULLY. UPON REMOVAL OF THE DELIVERY SYSTEM, FEMORAL ARTERY TISSUE WAS SEEN ON THE DELIVERY CATHETER. A 20FR SHEATH WAS INSERTED AND BLOOD PRESSURE WAS STABLE FOR A MOMENT AND THEN DROPPED SO BALLOON OCCLUSION WAS PERFORMED. DUE TO RIGHT ILIOFEMAL ARTERY DAMAGE/EVULSION THE PHYSICIANS ELECTED TO DIRECT FLOW FROM THE ABDOMINAL AORTA TO THE RIGHT FEMORAL HEAD THROUGH THE AREA OF THE INJURY WITH AND ENDURANT 23MM AUI AND 10MM LIMBS TO BE FOLLOWED WITH A RIGHT TO LEFT FEM- FEM GRAFT . ONCE THE AUI AND LIMBS WERE IN PLACE, BALLOON OCCLUSION WAS RELEASED. THE PATIENTS BP CONTINUED TO DROP AND A RETROGRADE ANGIOGRAM THE RIGHT REVEALED A DISUNION BETWEEN ETLW16010C124E AND ETEW1010C82E. BALLOON OCCLUSION WAS ESTABLISHED VIA THE LEFT SIDE (BEHIND THE AUI). IN ORDER TO MAINTAIN BP WHILE WORKING ON THE RIGHT. AN ETEW1313C82E WAS PLACED TO BRIDGE THE ENDURANT LIMBS WITH A NON MDT 12MM X 38MM COVERED STENT TO SECURE IT. B ALLOON OCCLUSION IN THE RI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 15824259 ↗
• InjuryApr 21, 2021Obstruction of Flow; Obstruction of Flow

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ELECTIVE ENDOVASCULAR TREATMENT OF A 50MM AAA. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE ETBF3216C145E WAS EXTENDED WITH AN ETLW1624C124E TO SEAL PROXIMAL TO THE RIGHT INTERNAL ILIAC AND THEN ETLW1610C156E EXTENDED WITH ETEW1010C82E INTO THE LEFT EXTERNAL AFTER LEFT INTERNAL EMBOLIZATION WITH AN NON-MDT PLUG. APPROX. 6 YEARS 4 MONTHS POST IMPLANT, THE PATIENT PRESENTED WITH A SHRINKING 4.4CM FUSIFORM AAA WITH AN OCCLUDED LEFT LIMB THAT EXTENDS INTO THE TORTUOUS LEFT EXTERNAL ILIAC.  THE RIGHT COMMON ILIAC MEASURED APPROX. 23MM , WHICH IS SEALED WITH A 24MM FLARED LIMB PROXIMAL TO THE RIGHT INTERNAL ILIAC OSTIA. PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION OCCURRED DUE TO COMPRESSION OF THE ETEW1010C82E IN TORTUOUS ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED

  Patient problems: Obstruction/Occlusion

  MAUDE report 11700416 ↗
• InjuryDec 2, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 80MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE, FOLLOW UP SHOWED A SUSPECTED TYPE IA OR TYPE IB ENDOLEAK. INTERVENTION WAS PERFORMED. DURING THE INTERVENTION PROCEDURE WHEN PASSING A WIRE UP THE LEFT SIDE THE PHYSICIAN NOTICED THE WIRE WENT INTO THE SAC. AN ANGIOGRAM IN THE LEFT ILIAC SHOWED WHAT APPEARED TO BE A TYPE 1B LEAK OF THE LEFT LIMB. A ETEW1010C82E ((B)(4)) WAS IMPLANTED AND THE ENDOLEAK CONFIRMED AS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 10934247 ↗
• MalfunctionSep 3, 2019Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  AN ENDURANT II STENT GRAFT SYSTEM WAS PLANNED TO BE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ILIAC AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE WHEN PREPPING THE DEVICE FOR THE PATIENT THE DEVICE GRAFT COVER WAS OBSERVED TO BE SLIGHTLY DENTED. A WIRE WAS ATTEMPTED TO BE PLACED THROUGH THE WIRE GUIDE BUT WOULD NOT PASS THROUGH THE DEVICE. THE BOX AND GRAFT PACKAGING LOOKED INTACT. A NON MDT REPLACEMENT DERIVE WAS USED TO COMPLETE THE PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE DENT WAS SUSPECTED TO BE FROM MANUFACTURING DAMAGE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8955370 ↗
• DeathJun 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS PLANNED TO BE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PHYSICIAN ATTEMPTED TO INTRODUCE THE BIFURCATED STENT GRAFT ETBF2313C124E THOUGHT THE LEFT EXTERNAL ILIAC BUT WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE PHYSICIAN THEN PRE-DILATED THE LEFT EXTERNAL ILIAC WITH A NON MDT 8X40 PTA BALLOON AND IT WAS THOUGHT THAT AN ILIAC TEAR OCCURRED AT THIS POINT. THE PHYSICIAN WAS STILL UNABLE TO ADVANCE THE BIFURCATED STENT GRAFT DELIVERY SYSTEM THROUGH THE EXTERNAL ILIAC. THE PHYSICIAN REMOVED THE DELIVERY SYSTEM AND PLACED A 14F SHEATH TO ACHIEVE HAEMOSTASIS IN THE ARTERIOTOMY. THE PHYSICIAN THEN ATTEMPTED TO BALLOON THE LEFT EXTERNAL ILIAC WITH A 10 MM PTA BALLOON. UPON REMOVING THE CONTRAST FROM THE PTA BALLOON, THE ANAESTHESIOLOGIST STATED THAT THE BLOOD PRESSURE WAS DROPPING. THE PHYSICIAN THEN ADVANCED THE 14F SHEATH INTO THE DISTAL AORTA AND THEN PLACED AN ENDURANT II ILIAC EXTENSION STENT GRAFT ETEW1010C82E INTO THE SHEATH. AFTER POSITIONING THE SHEATH DISTAL TO THE ILIAC TEAR, THE PHYSICIAN DEPLOYED THE STENT GRAFT. THE PHYSICIAN STATED THAT THE

  Patient problems: Death

  MAUDE report 7645560 ↗

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-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-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-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