BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT

    MDR report key: 1508094 · Received October 13, 2009

    Report

    Report Number
    2183870-2009-00132
    Event Type
    Other
    Date Received
    October 13, 2009
    Date of Event
    September 14, 2009
    Report Date
    September 14, 2009
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE WAS PERFORMED ON THE SFA. SFA STENTING WITH FEMORAL ACCESS. THE PROTEGE EVERFLEX STENT WAS DEPLOYED SMOOTHLY; THE TIP AND INNER CLEAR TUBE CAME UNDONE BUT WAS RETRIEVED SUCCESSFULLY. NO INJURY TO PATIENT REPORTED.

    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 7653557

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention