BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROPLEX 10-SYSTEM DETACHABLE COIL (MCS)

    MDR report key: 2132241 · Received June 3, 2011

    Report

    Report Number
    2032493-2011-00013
    Event Type
    Death
    Date Received
    June 3, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TREATMENT OF A RUPTURED PCOM ANEURYSM (APPROX 5-6MM IN DIAMETER), SIX EMBOLIZATION COILS WERE DEPLOYED SUCCESSFULLY. HOWEVER, THE MICROCATHETER POSITION WAS STATED TO NOT BE STABLE. A SEVENTH COIL WAS POSITIONED IN THE ANEURYSM. THE DETACHMENT CONTROLLER WAS ACTIVATED AND INDICATED THAT THE DETACHMENT CYCLE WAS COMPLETE. DURING RETRACTION OF THE PUSHER, THE COIL ALSO MOVED PROXIMALLY. AT THIS TIME, THE MICROCATHETER LOST POSITION AND KICKED OUT OF THE ANEURYSM, THUS LEAVING THE TAIL END OF THE COIL IN THE CHOROIDAL ARTERY. AN ATTEMPT WAS MADE TO RETRIEVE THE COIL USING A SNARE, HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. THE PT WAS HEPARINIZED FOR 24 HOURS. AFTER STOPPING THIS REGIMEN, THE PT DEVELOPED A CLOT AND SUBSEQUENTLY DIED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPLEX 10-SYSTEM DETACHABLE COIL (MCS) EMBOLIZATION COIL HCG MICROVENTION, INC. 100202HS-V 110329H8

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death