BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERFX EMBOLIC PROTECTION DEVICE

    MDR report key: 1760713 · Received July 13, 2010

    Report

    Report Number
    2183870-2010-00121
    Event Type
    Injury
    Date Received
    July 13, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

    AFTER COMPLETION OF ATHERECTOMY TO THE RIGHT SFA AND RIGHT COMMON FEMORAL ARTERY, THE PHYSICIAN NOTICED THAT THE SPIDERFX FILTER BECAME STUCK ON THE NOSE CONE OF THE SILVERHAWK. THE FORCE NEEDED TO DISLODGE THE FILTER BASKET CAUSED THE BASKET TO BREAK AWAY FROM THE WIRE. IT WAS FOUND IN THE DISTAL END OF THE RIGHT SFA. THE FILTER WAS SNARED SUCCESSFULLY AND NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERFX EMBOLIC PROTECTION DEVICE NTE EV3 INC. SPD2-US-050-320 8616881

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SILVERHAWK LS-M| TRAILBLAZER SUPPORT CATHETER| EN SNARE 6-10MM