BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERFX EMBOLIC PROTECTION DEVICET

    MDR report key: 1883790 · Received October 21, 2010

    Report

    Report Number
    2183870-2010-00164
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    DURING A CAROTID ARTERY INTERVENTION, THE SPIDER WIRE TIP BROKE OFF. THE PHYSICIAN DILATED AND STENTED THE WIRE AGAINST THE VESSEL WALL. NO INJURY TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERFX EMBOLIC PROTECTION DEVICET NTE EV3 INC. SPD2-060-190 8447700

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 7F COOK SHEATH 90CM