BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 584969 · Received March 18, 2005

    Report

    Report Number
    3003742446-2005-01290
    Event Type
    Malfunction
    Date Received
    March 18, 2005
    Date of Event
    February 13, 2005
    Report Date
    March 18, 2005
    Manufacturer
    CORDIS L L C (PR)
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SHAFT BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS L L C (PR) NA 41104548

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN