BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 1951987 · Received December 29, 2010

    Report

    Report Number
    2954740-2010-00026
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 8, 2010
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE EXACT ROOT CAUSE OF THE PROBLEM REPORTED COULD NOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS. A SEARCH OF OUR FIELD SURVEILLANCE DATABASE YIELDED NO OTHER COMPLAINTS OF THIS TYPE WITH THIS LOT.

    Description of Event or Problem · 1

    PER RECEIVED REPORT: THE CAUSE WAS A WIDE NECKED PARAOPTHALMIC ANEURYSM. A 28MM CORDIS ENTERPRISE STENT WAS DEPLOYED PRIOR TO ATTEMPTING TO COIL THE ANEURYSM. THE MICROCATHETER POSITION WITH THE BOSTON SCIENTIFIC'S EXCELSIOR 10 MICROCATHETER WAS NOT OPTIMAL AND UPON INTRODUCTION OF THE COIL, THE MICROCATHETER GOT PUSHED OUT OF THE ANEURYSM. DURING REPOSITIONING, THE COIL WOULD NOT ADVANCE OR RETRACT. AT THIS POINT, THE COIL HAD STRETCHED AND BROKE BUT REMAINED INSIDE THE MICROCATHETER. A SMALL TAIL OF THE COIL PROTRUDED OUT OF THE MICROCATHETER. THE PHYSICIAN THOUGHT THAT AN ATTEMPT TO RETRIEVE THE REMAINING COIL WAS NOT NECESSARY. INSTEAD, ANOTHER STENT WAS DEPLOYED TO "TUCK" IN THE PROTRUDING COIL. PATIENT WAS PRESCRIBED WITH ASPIRIN AND PLAVIX AND WAS REPORTED TO BE INTACT AND NO COMPLICATIONS NOTED POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORPORATION F55322

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention