TALENT® OCCLUDER OCL18USRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994573087), received between Feb 21, 2017 and Feb 21, 2017 — classified as 1 death.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathFeb 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR ENDOVASCULAR TREATMENT OF A 70 MM MAX DIAMETER RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK DIAMETER MEASURED APPROX 22-27 MM. THERE WAS MINIMAL AORTIC NECK ANGULATION. THE VESSEL WAS MILDLY CALCIFIED. IT WAS REPORTED THE PATIENT WAS FULLY CODED BEFORE ARRIVING TO THE OPERATING ROOM. A CHEST COMPRESSION WAS DONE DURING THE IMPLANT PROCEDURE. DURING THE CHEST COMPRESSION, THE GUIDEWIRE ON THE CONTRALATERAL SIDE PUNCTURED THE ARTERY AND WAS SUBINTIMAL. AS A RESULT, THE PHYSICIAN WAS UNABLE TO CANNULATE THE GATE OF THE BIFURCATE. THE PATIENT RECEIVED TREATMENT. THE PHYSICIAN IMPLANTED AN ENDURANT AUI STENT GRAFT AND AN OCCLUDER; HOWEVER, THE EVENT DID NOT RESOLVE AND THE PATIENT EXPIRED. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS DUE TO THE PRE-OPERATIVE RUPTURED ANEURYSM AND THE AMOUNT OF BLOOD LOSS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Blood Loss; Death

  MAUDE report 6348081 ↗