BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT

    MDR report key: 1290984 · Received December 18, 2008

    Report

    Report Number
    2183870-2008-00235
    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

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFERENCE MDR 2183870-2008-00236 FOR OTHER PROTEGE EVERFLEX USED IN PROCEDURE.

    Description of Event or Problem · 1

    SFA STENTING-PATIENT ENROLLED IN PROSPERO TRIAL IN (B) (6): THROMBOSIS BYPASS NEEDED. NO PERMANENT DISABILITY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT FGE EV3 INC. PRP35-06-100-(NI) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other