BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER RX DRUG-ELUTING STENT

    MDR report key: 890999 · Received August 3, 2007

    Report

    Report Number
    MW5003337
    Event Type
    Death
    Date Received
    August 3, 2007
    Date of Event
    July 20, 2007
    Report Date
    August 3, 2007
    Manufacturer
    CORDIS
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN GENERALLY GOOD HEALTH PRIOR TO BEING ADMITTED TO THE HOSP FOR PERCUTANEOUS CORONARY INTERVENTION OF THE CIRCUMFLEX WHICH WAS PERFORMED IN 2007 UNEVENTFULLY, AND THE PT WAS BEGUN ON PLAVIX AND ASPIRIN. HE WAS RECEIVING INTERMITTENT DOSES OF HEPARIN AND DID RECEIVE ANGIOMAX. THE PT DEVELOPED A LOW-GRADE FEVER FOR 3 DAYS, MAXIMUM 100.1 DEGREES. ON TWO DAYS LATER, HE HAD A SHAKING CHILL AND WAS FOUND TO BE SEVERELY THROMBOCYTOPENIC AND LEUKOPENIC WITH WHITE COUNT 0.92 WITH RELATIVELY NORMAL DIFFERENTIAL, HEMATOCRIT 52.6% WITH PLATELET COUNT 16,000. FIBRINOGEN 876 WITH D-DIMER 3.14. EARLIER TODAY, HIS WHITE COUNT WAS 1480 WITH PLATELET COUNT 14,000. HIS URINE CULTURE FROM 1 DAY AGO WAS NEGATIVE. HIS WHITE BLOOD CELL COUNT WAS 6270 YESTERDAY WITH HEMATOCRIT 48% AND PLATELET COUNT 102, 000. PREVIOUS TO THAT, HIS PLATELET COUNT WAS COMPLETELY NORMAL. AS AN OUTPATIENT, HIS HEMATOCRIT WAS 48.7% WITH WHITE COUNT 7200 AND PLATELET COUNT 213, 000 ON NINE DAYS EARLIER. HE DEVELOPED A RASH TWO DAYS AFTER THE ORIGINAL DATE. THE PHYSICIAN DOES NOT BELIEVE HIS THROMBOCYTOPENIA IS A RESULT OF HEPARIN, BUT RATHER A DIRECT CORRELATION WITH THE DRUG ELUTING STENT. DATE OF USE: TWELVE DAYS IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER RX DRUG-ELUTING STENT STENT NIQ CORDIS CXS28300 13220223

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death