BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2050985 · Received April 4, 2011

    Report

    Report Number
    2954740-2011-00018
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    November 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL. WITHOUT THE RETURN OF THE DEVICE, THE EXACT ROOT CAUSE OF THE PROBLEM REPORTED COULD NOT BE DETERMINED. 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 TREATMENT OF AN ANEURYSM OF THE POSTERIOR COMMUNICATING SEGMENT, AT THE TIME OF IMPLANTATION OF THE LAST COIL IN THE ANEURYSM (DELTAPLUSH 2X2), THE PHYSICIAN NOTED THAT IT WAS NECESSARY TO REPOSITION THE COIL BY PULLING IT INTO THE MICROCATHETER. THE COIL DETACHED FROM THE DPU WITHOUT PRESSING THE "DETACH" BUTTON OF THE DCB. THERE WAS NO HARM TO THE PT BECAUSE THERE WAS A SELF EXPANDABLE STENT (ENTERPRISE) POSITIONED AT THE ANEURYSM NECK. EVENTUALLY, THE COIL WAS CAUGHT BETWEEN THE VESSEL WALL AND THE STENT. IN THIS PROCEDURE, 7 (SEVEN) MICROCOILS WERE USED WITHOUT ANY MORE DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORPORATION F63208

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention