BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 647447 · Received November 16, 2005

    Report

    Report Number
    3003742446-2005-01877
    Event Type
    Injury
    Date Received
    November 16, 2005
    Report Date
    November 16, 2005
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE ACUTE EVENT, THE PT WAS ADMITTED WITH AN (SAT) SUB-ACUTE THROMBOTIC EVENT OF A PREVIOUSLY TAXUS TREATED LESION. A CYPHER SATENT WAS IMPLANTED TO TREAT THE LESION, AND SOMETIME AFTER THE IMPLANT, THE PT SUFFERED A SECOND SAT EVENT AND EXPIRED. THIS COMPLAINT WAS RECEIVED FROM A SALES REP ABOUT A PT WHO EXPERIENCED TWO SUB ACUTE THROMBOSIS (SAT) EVENTS. A COUPLE OF MONTHS AGO THE PT WAS ADMITTED WITH AN SAT OF A PREVIOUSLY TAXUS STNET. DURING THE ACUTE EVENT, A CYPHER STENT WAS IMPLANTTED TO TREAT THE SAT. SOMETIME AFTER THE CYPHER STENT IMPLANT, THE PT SUFFERED A SECOND SAT EVENT AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS LLC (PR) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R