BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT EMBO SHIELD

    MDR report key: 1031634 · Received April 18, 2008

    Report

    Report Number
    MW5006319
    Event Type
    Other
    Date Received
    April 18, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ABBOTT - IRELAND VASCULAR MERVUE
    Product Code
    NFA
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CAROTID STENTING PROCEDURE. POLYURETHANE DETACHED FROM METAL FRAME AND EMBOLIZED IN ARTERY. RETRIEVAL WAS UNSUCCESSFUL, AND IT IS INSIDE THE PT. PT DEVELOPED STROKE AND HEMIPARESIS AND IS IN ICU UNDERGOING THE BEST MEDICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT EMBO SHIELD VASCULAR GUIDE CATHETER SHIELD NFA ABBOTT - IRELAND VASCULAR MERVUE 475161

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR