BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1163546 · Received September 17, 2008

    Report

    Report Number
    9616099-2008-02263
    Event Type
    Death
    Date Received
    September 17, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 20, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS OUS CYPHER SELECT PLUS SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADDITIONAL INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    APPROXIMATELY A YEAR POST PROCEDURE, A FAMILY MEMBER REPORTED THAT THE PT DIED (CARDIAC DEATH). THERE WAS NO EVIDENCE OF STENT THROMBOSIS OR A MYOCARDIAL INFARCTION. IT WAS NOTED THAT THE PT HAD PREVIOUSLY BEEN ASYMPTOMATIC, WITHOUT ANGINA. IT WAS ALSO NOTED THAT THE PATIENT'S PHYSICIAN ASSUMED, AND INFORMED THE FAMILY, THAT THE CAUSE OF DEATH WAS VENTRICULAR ARRHYTHMIA. HOWEVER, THE PT DIED AT HOME, THERE ARE NO ELECTROCARDIOGRAPHS TO SUSTAIN THE DEATH. A PT WAS INITIALLY ENROLLED IN THE STUDY IN 2007 WITH 2-VESSEL DISEASE. THE MAIN INDICATION FOR THE INTERVENTION WAS A PREVIOUS Q-WAVE MYOCARDIAL INFARCTION. THE LESION INITIALLY TREATED WAS IN THE PROXIMAL TO MILD CIRCUMFLEX. THE LESION HAD 80% STENOSIS AND WAS DE NOVO, IRREGULAR, MODERATELY TORTUOUS, ECCENTRIC AND MODERATELY CALCIFIED WITH ANGULATIONS BETWEEN 45 AND 90 DEGREES. A 2.5 X 23 MM CYPHER SELECT PLUS STENT WAS ELECTIVELY IMPLANTED AT 12 ATM. THE PATIENT'S BASELINE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. THE PATIENT'S INTRA PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL AND HEPARIN. THE PATIENT'S POST PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS AND BETA-BLOCKERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 13240727

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death 6F GUIDING CATHETER WAS USED DURING THE PROCEDURE