BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPIDERX EMBOLIC PROTECTION DEVICE

    MDR report key: 857127 · Received June 19, 2007

    Report

    Report Number
    2183870-2007-00042
    Event Type
    Death
    Date Received
    June 19, 2007
    Date of Event
    May 28, 2007
    Report Date
    May 31, 2007
    Manufacturer
    EV3 INC.
    Product Code
    NFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PROCEDURE WAS AN PTCA SVG CORONARY STENTING: THE SPIDER WAS WELL-PLACED AND THE STENT IMPLANTED CORRECTLY. IT WAS NOT POSSIBLE TO PUSH THE BLUE RECOVERY CATHETER OVER THE FILTER. PHYSICIAN RECOVERED THE FILTER WITHOUT THE RECOVERY CATHETER AND A DISSECTION OF THE VESSEL OCCURRED. IT SEEMS THAT SOME STRUTS OF THE STENT WERE DAMAGED AS WELL. A RE-PTCA AND STENT WAS NOT POSSIBLE AND THE PATIENT DIED 30 HOURS AFTER THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERX EMBOLIC PROTECTION DEVICE NFA EV3 INC. SPDRX-040 1242730 OR 1728534

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death