BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCI RETRIEVER V 2.5 FIRM

    MDR report key: 1080383 · Received July 22, 2008

    Report

    Report Number
    2954917-2008-00008
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 22, 2008
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K081305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED ON THE RETURNED DEVICE. THE RESULTS OF THE INVESTIGATION ON THE RETURNED DEVICE SHOWED THAT THE RETRIEVER DISTAL HELIX LOOPS WERE PROLAPSED (I.E. CROSSED OVER EACH OTHER) AND THERE WAS MINOR PLATINUM COIL SEPARATION IN THE HELIX. THIS IS TYPICAL OF ANY RETRIEVER DEVICE THAT IS USED IN A PT FOR A THROMBECTOMY PROCEDURE. THE MFG RECORD FOR MERCI RETRIEVER V 2.5 FIRM DEVICE, LOT NUMBER, 33245, WAS RETRIEVED AND NO ANOMALIES WERE FOUND THAT ARE RELATED TO THIS COMPLAINT. THE CURRENT DEVICE INSTRUCTIONS FOR USE (IFU) LISTS VESSEL DISSECTION AND PERFORATION AS KNOWN COMPLICATIONS. ALSO, THERE IS A WARNING IN THE IFU THAT PROVIDES RECOMMENDATIONS TO PREVENT VESSEL DAMAGE.

    Description of Event or Problem · 1

    A MALE PRESENTED WITH A CLOT LOCATED AT THE LEFT MCA BIFURCATION. ACCORDING TO THE PHYSICIAN, THE CLOT WAS WELL ADHERED TO THE VESSEL WALL. THE PHYSICIAN PERFORMED 3 CLOT RETRIEVAL ATTEMPTS USING THE MERCI RETRIEVER V 2.5 FIRM IN THE M1/M2 SEGMENT OF THE MCA. ON THE THIRD RETRIEVAL ATTEMPT, THERE WAS NO FLOW RESTORATION AND ACCORDING TO THE PHYSICIAN THE DISTAL M2 VESSEL WAS PERFORATED. THE PROCEDURE WAS STOPPED AT THAT TIME. THE LAST INFO RECEIVED REGARDING THE PT'S CONDITION INDICATED THAT THE PT WAS STABLE AND DOING OK GIVEN THE CIRCUMSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 2.5 FIRM CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL, INC. 90112 33245

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other