BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2050957 · Received April 4, 2011

    Report

    Report Number
    2954740-2011-00014
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON PRODUCT RECEIPT OF THE PRODUCT, VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED. THE COIL WAS NOT RETURNED NOR THE MICROCATHETER. THE KINKS OBSERVED ON THE HYPOTUBE AS RECEIVED ARE THE SAME FOLDING PATTERN REQUIRED TO FIT THE DEVICE INTO A SMALL BIO BAG. THE DEVICE POSITIONING UNIT (DPU) PASSED ELECTRICAL TESTING. INVESTIGATION REVEALED THAT THE MOST LIKELY ROOT CAUSE OF THE COIL'S NON DETACHMENT FOLLOWED BY AN UNINTENDED DETACHMENT DURING REMOVAL WAS DUE TO THE MELTING DETACHMENT FIBER EXTENDING OVER THE DETACHMENT ZONE. THE COIL WAS FINALLY RELEASED DURING RETRACTION INSIDE THE MICROCATHETER. IN ADDITION, WITHOUT THE RETURN OF THE DETACHMENT CONTROL BOX (DCB) AND THE CONNECTING CABLE USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY RELEVANT 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

    DURING THE STENTING/COILING OF AN UPRUPTURED POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM, THE PHYSICIAN DEPLOYED 15 MICROCOILS. THE SECOND COIL WAS A CASHMERE 4 X 4.5. ONCE THE PHYSICIAN PLACED THE 4 X 4.5 CASHMERE IN THE ANEURYSM AND ATTEMPTED TO DETACH IT, THE COIL DID NOT DETACH. THE PHYSICIAN ATTEMPTED TO REPOSITION COIL AND RE-DETACH COIL OVER 10 TIMES WITHOUT SUCCESS. UPON WITHDRAWAL OF THE COIL, IT DETACHED AFTER APPROX 2 CM WAS PULLED OUT OF THE ANEURYSM. THE PHYSICIAN WAS ABLE TO SLOWLY ADVANCE THE DETACHED COIL BACK INTO THE ANEURYSM WITH THE DPU. NO COIL REMAINED IN THE PARENT VESSEL. PHYSICIAN WAS ABLE TO PLACE 13 MORE COILS TO OCCLUDE THE ANEURYSM WITH NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORPORATION F43615

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention