BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE RX CAROTID

    MDR report key: 1241262 · Received November 18, 2008

    Report

    Report Number
    2183870-2008-00183
    Event Type
    Injury
    Date Received
    November 18, 2008
    Date of Event
    October 30, 2008
    Report Date
    November 11, 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

    PATIENT ENROLLED INTO THE TRIAL. MINOR ISCHEMIC STROKE REPORTED. AFTER DEPLOYMENT OF STENT, THE PATIENT HAD SLIGHT RIGHT HAND WEAKNESS. PATIENT WAS ALERT AND ORIENTED. THE ICU PATIENT WAS NOTED TO HAVE AN ACUTE STROKE. PATIENT HAD A NEURO CONSULT, EEG, US, AND CT OF HEAD WHICH SHOWED AN INFARCT. RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE RX CAROTID NIM NIM EV3 INC. SECX-10-7-40-135 2384953

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other