BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT

    MDR report key: 1291001 · Received December 18, 2008

    Report

    Report Number
    2183870-2008-00206
    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
    FR

    Narratives

    Description of Event or Problem · 1

    SFA STENTING-PATIENT ENROLLED IN (B) (6) TRIAL IN (B) (6): MILD OCCLUSION OF DEVICE REPORTED DURING PROCEDURE. PATIENT RECOVERED WITHOUT PERMANENT INJURY.

    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