BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 705644 · Received April 25, 2006

    Report

    Report Number
    9616099-2006-00479
    Event Type
    Injury
    Date Received
    April 25, 2006
    Date of Event
    October 17, 2005
    Report Date
    April 25, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HTE PT RECEIVED A CYPHER STENT IN EACH OF THE FOLLOWING LESIONS: MED LAD, MID RCA, AND OBTUSE MARGINAL CX. APPROX 31 MONS LATER, RESTENOSIS WAS NOTED IN THE PREVIOUSLY TREATED MED RCA LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT DQY CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R