Endurant® II ETLW1616C82E (UDI 00613994991577)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994991577), received between Sep 15, 2017 and Jul 3, 2024 — classified as 1 death, 5 injuries.

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.

• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AAA . 6 ENDOANCHORS WERE ALSO IMPLANTED. IT WAS REPORTED THAT THE PATIENT RANG TECHNICAL SERVICES AND STATED THAT POST THE INDEX PROCEDURE, FOLLOWING THE IMPLANT OF THE ENDURANT STENT GRAFTS, THE BLOOD FLOW WAS KINKED AND WAS BEING PINCHED OFF DOWN TOWARDS THE LEG. THE PHYSICIAN IMPLANTED A RIGID METAL STENT AS INTERVENTION. IT WAS CONFIRMED VIA THE SALES REP THAT DURING THE INDEX PROCEDURE, A BALLOON EXPANDABLE STENT WAS IMPLANTED IN THE LEFT ILIAC LIMB SECONDARY TO STENOSIS . AT THE END OF THIS PROCEDURE A POSSIBLE TYPE II ENDOLEAK WAS NOTED. POST FOLLOW UP WITH VARIOUS IMAGE MODALITIES SHOWED A POSSIBLE TYPE II ENDOLEAK. THE ANEURYSM STAYED THE SAME SIZE UNTIL OVER SIX YEAR LATER WHERE A 1.5 CM INCREASE WAS THEN NOTED. AT THIS TIME THE PHYSICIAN SUSPECTED A TYPE 3 LEAK AT THE RIGHT ILIAC LIMBS VIA CT AND A TYPE 1A ENDOLEAK VIA ULTRASOUND SCAN. THE PHYSICIAN DISCUSSED POSSIBLE SURGERY WITH THE PATIENT BUT BECAUSE OF THE PATIENTS PARKINSON'S DISEASE, THE PATIENT DECIDED TO WAIT. 3 MONTHS LATER, REPEAT IMAGING HAD SHOWED A TYPE 1A ENDOLEAK ON CT AND SMALL INCREASE IN AAA DIAMETER. AN ANGIOGRAM

  Patient problems: Obstruction/Occlusion

  MAUDE report 19664249 ↗
• InjuryDec 10, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE, THE PATIENT AS COMPLAINING OF ABDOMINAL PAIN. A CT PERFORMED SHOWED A TYPE IB ENDOLEAK AT THE RIGHT COMMON ILIAC WITH MINIMAL CONTRAST FILLING ANEURYSM SAC DUE TO POOR DISTAL SEALING ZONE OF THE ENDURANT LIMB ETLW1616C82E. A POTENTIAL TYPE IA ENDOLEAK WAS ALSO SEEN ON THE CT. INTERVENTION WAS PERFORMED THE NEXT DAY, THE RIGHT COMMON ILIAC ARTERY WAS EXTENDED WITH A 16 X 24 X 93 TO ACHIEVE DISTAL SEAL. ADDITIONALLY, A 32 X 32 X 49 CUFF WAS PLACED IN PROXIMAL NECK SECURED WITH 8 ENDOANCHORS PROPHYLACTICALLY. THE POTENTIAL TYPE 1A PRESENT ON THE CTA WAS NOT VISUALIZED ON ANGIOGRAM DURING THE SECONDARY PROCEDURE. THE PROXIMAL CUFF AND HELI-FX ANCHORS WERE PLACED PROPHYLACTICALLY TO PREVENT CONTINUED DISEASE PROGRESSION THAT WAS INITIATED BY THE DISTAL TYPE 1B. AFTER PLACEMENT OF THESE PIECES, FINAL ANGIOGRAM CONFIRMED NO PRESENCE OF ANY ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS UNDER SIZING. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 10982025 ↗
• DeathAug 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS ALSO IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM APPROXIMATELY EIGHT MONTHS LATER. IT WAS REPORTED VIA TECHNICAL SERVICES BY THE PATIENT'S SON THAT THE PATIENT¿S STENT GRAFT HAS ¿BURST¿ AND THE PATIENT HAD DIED FOUR YEARS THREE MONTHS POST THE IMPLANTATION OF THE VALIANT CAPTIVIA STENT GRAFT SYSTEM. THE CALLER REPORTED THAT THE PHYSICIAN WAS GOING TO REPORT THE INCIDENT TO THE FDA AS A DEVICE FAILURE. THE CALLER HAS NOT SPOKEN TO THE PHYSICIAN SINCE THE EVENT OCCURRED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Rupture

  MAUDE report 8883333 ↗
• InjuryJan 25, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT DURING A FOLLOW-UP CT PERFORMED APPROXIMATELY 4 YEARS POST INDEX PROCEDURE, A POSSIBLE TYPE IB ENDOLEAK WAS NOTED. THE RIGHT EXTERNAL ILIAC WAS ALSO OCCLUDED. THE PHYSICIAN STATED THE CAUSE OF THE EVENT WAS ANATOMY RELATED; CONTINUED VESSEL DILATION AND UNDERSIZED STENT GRAFT. IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS LATER A RE-INTERVENTION WAS PERFORMED DURING WHICH THE PHYSICIAN EXTENDED THE STENT GRAFT LIMBS TO PROVIDE SEAL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Injury; Occlusion

  MAUDE report 7217963 ↗
• InjuryOct 20, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A FOLLOW UP CT SCAN, A DISTAL TYPE I ENDOLEAK WAS IDENTIFIED. A SECONDARY INTERVENTION WAS PERFORMED AND ANOTHER VALIANT DEVICE WAS IMPLANTED. THIS REPORTEDLY RESOLVED THE ENDOLEAK. 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: Injury

  MAUDE report 6964292 ↗
• InjurySep 15, 2017Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ANEURYSM. THERE WAS A TYPE III ENDOLEAK ¿SQUIRTING¿ FORM THE MID PORTION OF THE STENT GRAFT. VIA SUTURE TECHNIQUE, THE PHYSICIAN SUCCESSFULLY TREATED THE RUPTURED STENT GRAFT .IT WAS ALSO NOTED THAT THE ENTIRE STENT GRAFT WOULD OOZE OR LEAK AROUND THE SUTURES. THE EVENT REPORTEDLY RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; Rupture

  MAUDE report 6868491 ↗

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-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-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-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