BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE

    MDR report key: 1071464 · Received June 26, 2008

    Report

    Report Number
    1071464
    Event Type
    Malfunction
    Date Received
    June 26, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 20, 2008
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE STENT DID NOT DEPLOY. THE STENT AND GUIDEWIRE WERE REMOVED AS A UNIT. THE STENT WAS INTACT ON SYSTEM. THE GUIDEWIRE WAS STUCK IN THE STENT DELIVERY SYSTEM. THE STENT WOULD NOT UNSHEATH(DEPLOY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE STENT FGE EV3 INC. PBR35-08-040-120 2628431

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR