BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® LIBERTÉ® ATOM¿

    MDR report key: 3051219 · Received April 10, 2013

    Report

    Report Number
    2134265-2013-02276
    Event Type
    Death
    Date Received
    April 10, 2013
    Date of Event
    December 17, 2012
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT. IT WAS INDICATED THAT THE DEVICE WOULD NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. IT WAS REPORTED STENTING TREATMENT POST PROCEDURE, DEATH OCCURRED. DURING PERCUTANEOUS CORONARY INTERVENTION (PCI), PROCEDURE, THE TAXUS LIBERTE, ATOM MONORAIL 12 X 2.25MM CORONARY DRUG-ELUTING STENT WAS IMPLANTED IN THE UNSPECIFIED LOCATION ON (B)(6) 2010. THE PATIENT DIED ON (B)(6) 2012. THE REPORTED CAUSE OF THE DEATH IS ASYSTOLE. THERE WAS NO AUTOPSY REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153183 TAXUS® LIBERTÉ® ATOM¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612220 13027819

    Patients

    Seq Age Sex Outcome Treatment
    1 Death