BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM 10-8MMX40MM

    MDR report key: 1812151 · Received August 17, 2010

    Report

    Report Number
    MW5017149
    Event Type
    Death
    Date Received
    August 17, 2010
    Date of Event
    July 6, 2010
    Report Date
    August 16, 2010
    Manufacturer
    EMBOSHIELD NAV
    Product Code
    NIM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY ASS DIR OF (B)(6), (B)(6) VIA E-MAIL, THE PT, (B)(6) SUSTAINED COMPLICATION OF CAROTID STENTING. CHART REFLECTS COMPLICATION AS: (L ICA STENTING) STENT SHEATH FRACTURED DURING DEPLOYMENT. EMBOSHIELD DISTAL PROTECTION DEVICE COULD NOT BE REMOVED POST PROCEDURE AND REMOVED IN OPERATING ROOM; IN OPERATING ROOM: REMOVAL OF HARDWARE, L CAROTID ANGIOGRAM. PT HAD INFARCTED L MCA, L DISTAL ICA. CURRENTLY IN CCU. DNR SIGNED BY FAMILY ON (B)(6) 2010. ORGAN DONATION CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM 10-8MMX40MM STENT SYSTEM NIM EMBOSHIELD NAV REF#82096-01 0012151RX
    2 EMBOSHIELD NAV - 7.2MM - FILTER EMBOLIC DISTAL PROTECTION DEVICE NTE REF#22438-19 0052152RX

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death