BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 537923 · Received August 4, 2004

    Report

    Report Number
    3003742446-2004-00835
    Event Type
    Injury
    Date Received
    August 4, 2004
    Date of Event
    June 10, 2004
    Report Date
    August 4, 2004
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NON Q MI AND PLAQUES SHIFT INTO A SIDE BRANCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS LLC (PR) NA X0404682

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization