BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPIDERFX EMBOLIC PROTECTION DEVICE

    MDR report key: 858671 · Received May 31, 2007

    Report

    Report Number
    2183870-2007-00034
    Event Type
    Other
    Date Received
    May 31, 2007
    Date of Event
    May 2, 2007
    Report Date
    May 2, 2007
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS PERFORMED IN ANOTHER COUNTRY. CAS PROCEDURE WITH FEMORAL ACCESS. THE GREEN CATHETER OF THE SPIDERFX WAS POSITIONED IN THE INTERNAL CAROTID AND WHEN THE SURGEON PUSHED THE SPIDERFX IN ORDER TO DEPLOY IT, THE SPIDERFX CAME THROUGH THE GUIDE WIRE RX PORT AND WAS DEPLOYED IN THE EXTERNAL CAROTID. NO PT INJURY WAS REPORTED AND PT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERFX EMBOLIC PROTECTION DEVICE NTE NTE EV3 INC. SPD2-060-190 2596311

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR COOK GUIDE CATHETER