BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER FX 6.0 MM -320/190 CM, .014

    MDR report key: 2172224 · Received July 20, 2011

    Report

    Report Number
    MW5021423
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 12, 2011
    Manufacturer
    EV3
    Product Code
    NTE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD SEVERE CAD WITH CALCIFICATION. DEVICE WAS INSERTED INTO RIGHT SUPERIOR FEMORAL ARTERY. ATHERECTOMY COMPLETED AND THERE WAS AN UNSUCCESSFUL ATTEMPT TO REMOVE SPIDER DEVICE FROM LEG. THE SPIDER DEVICE (OR NET AT END) BROKE OFF. IT HAD TO BE STITCHED IN PLACE AND THEN REMOVED IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER FX 6.0 MM -320/190 CM, .014 EMBOLIC PROTECTION DEVICE NTE EV3 SPD2-US-060-320 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention