BEUDAMED
    FDA Adverse Event Summary report: N

    RX ACCUNET

    MDR report key: 2495254 · Received March 7, 2012

    Report

    Report Number
    2495254
    Date Received
    March 7, 2012
    Date of Event
    March 6, 2012
    Report Date
    March 7, 2012
    Manufacturer
    ABBOTT LABORATORIES, INC
    Product Code
    NTE
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER DEPLOYMENT OF A RIGHT CAROTID ARTERY STENT, THE EMBOLIC PROTECTION DEVICE (EPD) NEEDED TO BE REMOVED. MULTIPLE CAPTURE DEVICES WERE USED UNSUCCESSFULLY TO REMOVE THE EPD. BALLOONS WERE ALSO USED TO TRY TO DILATE THE BALLOON TO ALLOW FOR THE EPD TO BE REMOVED, ALSO UNSUCCESSFULLY. EVENTUALLY, THE WIRE ATTACHED TO THE EPD BROKE, LEAVING THE EPD IN THE RIGHT CAROTID ARTERY DISTAL TO THE STENT. THE MD EMBOLIZED THE RIGHT CAROTID ARTERY PROXIMAL TO THE STENT, OCCLUDING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET CATHETER, CAROTID, EMBOLIC CAPTURE NTE ABBOTT LABORATORIES, INC 1011649-55 1110261

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR NO OTHER THERAPIES