Endurant® II ETLW1616C199ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169467651), received between Nov 17, 2017 and Oct 19, 2021 — classified as 1 death, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM++ ABDOMINAL AORTIC ANEURYS. HELI-FX ENDOANCHORS WERE ALSO IMPLANTED. IT WAS REPORTED APPROXIMATELY 4 YEARS AND 9 MONTHS LATER FOLLOW UP CT SHOWED LOSS OF SEAL IN THE LEFT LIMB. ALTHOUGH THE NECK SEAL HAS SHORTENED, THERE IS NO TYPE IA ENDOLEAK IDENTIFIED. THE ANEURYSM, HOWEVER, HAS GROWN DISTALLY. THE RIGHT LIMB SEEMS TO HAVE ABOUT 15 MM OF SEAL AND THE LEFT LIMB HAS APPROXIMATELY 4MM OF SEAL WITH A TAPE II ENDOLEAK. INTERVENTION WAS PERFORMED, THE AORTIC NECK WAS CHECKED FIRST AND THERE WAS NO LEAK OF ANY SORT PRESENT. THE PHYSICIAN THEN EXTENDED THE LEFT AND RIGHT SIDE TO THE HYPOGASTRIC ARTERY WITH ENDURANT LIMBS. THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH NO ENDOLEAKS OF ANY KIND NOTED. PER THE PHYSICIAN THE CAUSE OF THE LOSS OF SEAL IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12654993 ↗
• InjurySep 23, 2021Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF 48MM HYPOGASTRIC ANEURYSM.  IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE ENDURANT STENT (6X16X199) WAS IMPLANTED A TYPE III ENDOLEAK WAS IDENTIFIED THROUGH THE GRAFT. THE PHYSICIAN RELINED WITH AN ADDITIONAL 2 STENTS (16X16X156 <(>&<)> A 16X16X124) AND THE ENDOLEAK WAS CONFIRMED AS RESOLVED.  PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS DUE TO GRAFT DISRUPTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12519343 ↗
• DeathJul 28, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT 2 AND A HALF YEARS LATER, A CT IMAGES WERE REVIEWED, WHERE A ENDOLEAK TYPE 1B WAS NOTED. IT WAS REPORTED THE TYPE IB ENDOLEAK APPEARED TO TOUCH BOTH OF THE IMPLANTED DEVICES. IT WAS REPORTED AN ADDITIONAL TWO SURGICAL REPAIR PROCEDURES WERE PERFORMED AND THE PATIENT EXPIRED DURING THE SECOND PROCEDURE. IT WAS REPORTED THE CAUSE OF DEATH WAS AN INTRA-OPERATIVE RUPTURED ANEURYSM. IT WAS NOTED THAT DURING THE FIRST INTERVENTION PROCEDURE, AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED ALONG WITH A VALIANT NAVION STENT GRAFT. THE PATIENT REPORTEDLY EXPIRED DURING THE SECOND PROCEDURE WHERE TWO FURTHER STENT GRAFTS HAD BEEN IMPLANTED, A ENDURANT LIMB AND A VALIANT NAVION STENT GRAFT. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information; Rupture

  MAUDE report 12238464 ↗
• InjuryNov 17, 2017Leak/Splash; Leak/Splash

  A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM DIAMETER ABDOMINAL AORTIC ANEURYSM ON. ENDURANT STENT GRAFTS WERE IMPLANTED DURING A SECONDARY PROCEDURE FOR AN UNKNOWN REASON ON (B)(6) 2015. CURRENTLY THE VESSELS ARE SEVERELY TORTUOUS AND MODERATELY CALCIFIED. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 8 YEARS POST INDEX PROCEDURE AND APPROXIMATELY 2 YEARS POST SECONDARY PROCEDURE WITH SYMPTOMS OF A RUPTURED ANEURYSM. A TYPE III ENDOLEAK WAS IDENTIFIED WHERE THE CONTRALATERAL LIMB PULLED OUT OF THE CONTRALATERAL GATE (LEFT) OF THE ORIGINAL TALENT BIFURCATED STENT. A 14X16X105 TALENT LIMB WAS IDENTIFIED AS THE CONTRALATERAL LIMB. THE 16X16X199 ENDURANT LIMB WAS IDENTIFIED AS THE DEVICE THAT PULLED OUT ALONG WITH THE 14X16X105 TALENT LIMB. THE ENDURANT LIMB WAS USED IN A PREVIOUS UNKNOWN SECONDARY INTERVENTION TO RELINE THE STENT GRAFT. THE PHYSICIAN IMPLANTED A 36MM ENDURANT AUI AND 16X16X156 ENDURANT LIMB FROM THE LEFT SIDE TO BRIDGE INTO THE EXISTING SYSTEM FOLLOWED BY A FEM-FEM BYPASS WITH ANOTHER MANUFACTURER PLUG PLACED IN THE RIGHT COMMON ILIAC ARTERY TO OCCLUDE IT. POST ANGIO SHOWED CONTINUED TYPE III

  Patient problems: Rupture

  MAUDE report 7040088 ↗

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-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