BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARAMOUNT MINI GPS

    MDR report key: 586821 · Received May 28, 2004

    Report

    Report Number
    2134479-2004-00005
    Event Type
    Malfunction
    Date Received
    May 28, 2004
    Date of Event
    April 30, 2004
    Report Date
    May 27, 2004
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PREDILATED WITH A 3.0 CROSS SAIL AT 8 ATMS FOR 8 SECONDS. STENT WOULD NOT CROSS-PREDILATED LESION, WHEN PHYSICIAN WENT TO REMOVE THE STENT, THE STENT MOVED DISTAL AND THEN CAME OFF OF THE BALLOON CATHETER. THE PHYSICIAN EVENTUALLY RETRIEVED THE STENT WITH AN ENSNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARAMOUNT MINI GPS STENT FGE EV3 INC. PMB4-5-14-80 562786

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention