BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT

    MDR report key: 961641 · Received December 5, 2007

    Report

    Report Number
    2183870-2007-00093
    Event Type
    Other
    Date Received
    December 5, 2007
    Date of Event
    November 1, 2007
    Report Date
    November 8, 2007
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN ANOTHER COUNTRY: DURING DEPLOYMENT OF THE STENT, THE DELIVERY CATHETER BROKE AND THE STENT HAD A STRANGE DEPLOYMENT PATTERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT FGE EV3 INC. PRB35-07-150-120 4066997

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention