BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE RX CAROTID STENTING SYSTEM

    MDR report key: 1013118 · Received March 14, 2008

    Report

    Report Number
    2183870-2008-00029
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 22, 2008
    Manufacturer
    EV3 INC.
    Product Code
    NIM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT ENROLLED INTO A CAROTID CREATE PAS TRIAL. PT STROKED AFTER PLACEMENT OF PROTEGE RX STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE RX CAROTID STENTING SYSTEM NIM EV3 INC. SECX-10-7-40-135 2556946

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other 6FR SHUTTLE SHEATH| BMW 300 CM WIRE| QUANTUM 5.0X20 CORONARY BALLOON| SPIDER RX 6.0