BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPIDERFX EMBOLIC PROTECTION DEVICE

    MDR report key: 1013102 · Received March 14, 2008

    Report

    Report Number
    2183870-2008-00026
    Event Type
    Death
    Date Received
    March 14, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 25, 2008
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT ENROLLED INTO THE CREATE PAS TRIAL. DURING THE PROCEDURE, THE PROTECTIVE DEVICE WAS FILLED WITH PLAQUE AND CLOT AND AN EMBOLUS WAS DISLODGED ENDING IN LMCA CAUSING A STROKE. FOLLOWING PROCEDURE PATIENT WAS GLOBALLY APHASIC WITH NO MOVEMENT OF RIGHT SIDE OF BODY. HEAD CT ON 02/2008 REVEALED FAINT LMCA DISTRIBUTION AREA OF HYPODENSITY FELT TO BE CONSISTENT WITH LMCA INFARCT. LIKELY ETIOLOGY TO NEUROLOGICAL CHANGE WERE FELT TO BE: EMBOLIC SHOWER IN DISTAL BRANCHES OF LMCA; HYPERFUSION SYNDROME FROM OPENING LICA BULB; CONTRAST "STUN" OF LMCA HEMISPHERE DISTRIBUTION; ISCHEMIC INJURY DUE TO TEMPORARY OCCLUSIONS PERFORMED DURING THE LICA AND LMCA SAPTAS. REPEAT CT LATER SHOWED LEFT FRONTAL INFRACT. PATIENT DEVELOPED CONGESTIVE HEART FAILURE WITH RESPIRATORY COMPROMISE AND DIED ELEVEN DAYS LATER. PRIMARY CAUSE OF DEATH LISTED AS CONGESTIVE HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERFX EMBOLIC PROTECTION DEVICE NTE EV3 INC. SPD2-VC-050-320 2885303

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death PROTEGE RX STENT