BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 869033 · Received June 21, 2007

    Report

    Report Number
    9616099-2007-01157
    Event Type
    Death
    Date Received
    June 21, 2007
    Date of Event
    July 26, 2005
    Report Date
    June 11, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT WAS RANDOMIZED TO THE FOREIGN REGISTRY ON MAY 27, 2006. THE INDICATION FOR THE INDEX PROCEDURE IS UNKNOWN. THE TARGET LESION IS DESCRIBED AS BEING DENOVO, WITH MODERATE CALCIFICATION AND <10MM IN LENGTH. PREDILATATION WAS CONDUCTED WITH AN UNKNOWN BALLOON FOLLOWED BY DEPLOYMENT OF ONE CYPHER SIROLIMUS-ELUTING CORONARY STENT IN THE PROXIMAL RCA. PLEASE NOTE: THE DEVICE INVOLVED IN THIS CASE WITH AN UNKNOWN CATALOG AND LOT NUMBER IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT CYPHER SIROLIMUS-ELUTING CORONARY STENT. A CODE FOR THROMBOSIS EVENT HAS BEEN ADDED TO THIS REPORT IN ACCORDANCE WITH THE ACADEMIC RESEARCH CONSORTIUM (ARC) GUIDELINES FOR THROMBOTIC EVENTS. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE FOLLOWING REPORT WAS RECEIVED FROM THE FOREIGN REGISTRY; APPROXIMATELY TWO MONTHS POST INDEX PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH REMAINS UNKNOWN. THE EVENT WAS REPORTED AS POSSIBLY RELATED TO THE INDEX PROCEDURE AND INDEX DEVICE.

    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 92 YR Death