BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2459726 · Received February 8, 2012

    Report

    Report Number
    2954740-2012-00005
    Event Type
    Injury
    Date Received
    February 8, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 12, 2012
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED AND WILL NOT BE 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

    PER RECEIVED REPORT: IT WAS A PT WITH 3 ANEURYSMS. THE FIRST ONE HAS BEEN CLIPPED ABOUT ONE WEEK BEFORE THIS INTERVENTION. DURING THIS PROCEDURE, THE COIL HAS BEEN STRETCHED AND TORN OFF. THIS WAS THE SECOND COIL, THE FIRST ONE WAS A MICROSPHERE WHICH HAD BEEN PLACED SUCCESSFULLY IN THE ANEURYSM. THEY USED A EXCELSIOR SL 10 AS MICRO CATHETER, A ENVOY 6F AS GUIDING CATHETER AND AS GUIDEWIRE A SYNCHRO. THE NEUROSURGEON (HE WAS PRESENT DURING THE PROCEDURE BECAUSE OF THE DIFFICULT ANATOMICAL CHARACTERISTICS) DECIDED TO CLIP ALSO THE SECOND ANEURYSM, BUT FIRST THEY REMOVED THE HELIPAQ. THE PT OUTCOME IS GOOD. ADD'L INFO/CLARIFICATION RECEIVED ON (B)(6) 2012 STATED THAT THE COIL STRETCHED DURING WITHDRAWAL AND THE ANEURYSM PORTION OF THE COIL WAS RETRIEVED, HOWEVER, THE INTRAVASCULAR PORTION HAD TO BE CLIPPED AND 2CM OF THE COIL WAS LEFT IN THE PETROSAL PART OF THE CAROTID ARTERY. THE PT WAS PRESCRIBED ASS 100 FOR SIX WEEKS FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORPORATION F64051

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention