BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORDIS RX

    MDR report key: 516228 · Received March 8, 2004

    Report

    Report Number
    MW1031459
    Event Type
    Death
    Date Received
    March 8, 2004
    Date of Event
    March 1, 2004
    Report Date
    March 5, 2004
    Manufacturer
    J & J CORDIS
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION OF CYPHER RX CXS23350 3.50MM X 23 MM DRUG-ELUTING CORONARY ARTERY STENT INTO LEFT ANTERIOR DESCENDING DISSECTION OF VESSEL OCCURRED RESULTING IN CARDIAC TAMPONADE. RESUSCITATION MEASURES WERE UNSUCCESSFUL: INTUBATION, CARDIAC MEDICATIONS, BLOOD ADMINISTRATION. PROCEDURE: SAME DAY ADMISSION FOR CARDIAC CATH= PTC AND STENT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS RX CORDIS CYPHER STENT DRUG ELUTING NIQ J & J CORDIS CXS23350 A1203079

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death