BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 595281 · Received April 22, 2005

    Report

    Report Number
    9616099-2005-00924
    Event Type
    Death
    Date Received
    April 22, 2005
    Report Date
    April 22, 2005
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT EXPIRED APPROXIMATEY 122 DAYS AFTER THE INDEX PROCEDURE. THE EVENT WAS REPORTED TO BE: A MACE EVENT, CARDIAC DEATH OF OTHER CAUSE, SUDDEN DEATH, A SEVERE EVENT AND FATAL. THERE WAS NO INTERVENTION OR HOSPITALIZATION PERFORMED. THE INDICATION FOR THE INDEX PROCEDURE WAS A RECENT Q-WAVE MYOCARDIAL INFARCTION (MI) (<=24 HOURS). THROMBOLYTICS WERE NOT GIVEN. THE PT WAS FOUND TO HAVE SINGLE VESSEL CORONARY DISEASE, AND A PROTECTED LEFT MAIN CORONARY ARTERY (LMCA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death