BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT

    MDR report key: 1290998 · Received December 18, 2008

    Report

    Report Number
    2183870-2008-00234
    Event Type
    Other
    Date Received
    December 18, 2008
    Report Date
    July 3, 2008
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SFA STENTING-PATIENT ENROLLED IN PROSPERO TRIAL IN (B) (6): DEVICE WOULD NOT CROSS THE LESION AND THE PATIENT WAS SENT TO SURGERY. NO PERMANENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT FGE EV3 INC. PRP35-06-015-(NI) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other