BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER FX EMBOLIC PROTECTION DEVICE

    MDR report key: 2250893 · Received September 12, 2011

    Report

    Report Number
    2250893
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 24, 2011
    Report Date
    September 12, 2011
    Manufacturer
    EV3
    Product Code
    NFA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US

    Narratives

    Description of Event or Problem · 1

    A PIECE OF THE FILTER WAS LEFT IN THE VESSEL. THE DOCTOR HAD DIFFICULTY PLACING THE FILTER WIRE IN THE VESSEL. HE BEGAN TO IVUS (ULTRASOUND) THE VESSEL. THE DOCTOR WAS UNABLE TO FULLY ENCASE THE DEVICE IN THE RETRIEVAL PORTION OF THE CATHETER. THE DOCTOR PULLED EVERYTHING BACK, AND BASKET PORTION OF THE FILTER REMAINED IN THE GRAFT VESSEL, SLOWING FLOW. THE DOCTOR WAS ABLE TO PASS A WIRE BY THE BASKET AND BALLOON, AND STENT THE BASKET TO THE SIDE WALL OF THE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER FX EMBOLIC PROTECTION DEVICE FILTER BASKET NFA EV3 SPD2-US-060-320 9469776

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR