BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 980828 · Received January 15, 2008

    Report

    Report Number
    9616099-2008-00127
    Event Type
    Death
    Date Received
    January 15, 2008
    Date of Event
    September 28, 2007
    Report Date
    December 19, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE REGISTRY INDICATING THAT THIS PATIENT EXPERIENCED ANGINA PECTORIS DURING THE ONE MONTH FOLLOW UP. THEN APPROXIMATELY TWO MONTHS AFTER THE IMPLANTATION OF THE 3.0X23 CYPHER STENT, THE PATIENT EXPIRED. THE CARDIAC DEATH WAS SPECIFIED AS SUDDEN DEATH AT THE PATIENT'S HOME. THERE WAS NO EVIDENCE OF MYOCARDIAL INFARCTION OR STENT THROMBOSIS, AND AN AUTOPSY WAS NOT PERFORMED. THE RELATIONSHIP OF THIS EVENT TO THE CORDIS STENT WAS POSSIBLY RELATED. BASED ON THE ACADEMIC RESEARCH CONSORTIUM (ARC) GUIDELINES, THIS EVENT IS ALSO BEING REPORTED AS A THROMBOTIC EVENT.

    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 13192933

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death 1.5X15 BALLOON CATHETER| 6F GUIDING CATHETER