BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2100739 · Received May 18, 2011

    Report

    Report Number
    2954740-2011-00025
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RECEIVED IN OUR FACILITY AS OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED AS SOON AS IT'S RECEIVED AND THE FINAL ANALYSIS HAS BEEN CONDUCTED.

    Description of Event or Problem · 1

    DURING REPOSITIONING OF THE COIL INTO THE ANEURYSM, THE COIL UNINTENTIONALLY DETACHED OUT OF THE MICROCATHETER WITH NO DETACHMENT ATTEMPTED. TO PREVENT COIL MIGRATION AND THROMBUS PROGRESSION, AN INTRACRANIAL STENT WAS PLACED TO HAVE THE COIL REMAIN IN PLACE. GLYCOPROTEIN IIA-IIIA WAS ADMINISTERED TO PREVENT ACUTE THROMBOSIS. THE PT REMAINED IN INTENSIVE CARE UNIT AS OF THIS REPORT. ADDITIONAL INFO RECEIVED ON 05/13/2011 STATED THAT THE COIL WAS NEVER CONNECTED TO THE DETACHMENT CONTROL BOX (DCB) WHEN IT DETACHED AND THE PT REQUIRED A SURGICAL CLIPPING OF THE ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORPORATION F57505

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention