BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCI RETRIEVER V 2.5 SOFT

    MDR report key: 1583515 · Received January 18, 2010

    Report

    Report Number
    2954917-2009-00027
    Event Type
    Injury
    Date Received
    January 18, 2010
    Date of Event
    November 18, 2009
    Report Date
    January 18, 2010
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K081305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    PATIENT WAS A MALE WHO PRESENTED WITH STROKE SYMPTOMS. MECHANICAL THROMBECTOMY WAS FIRST ATTEMPTED WITH THE PENUMBRA SYSTEM WITHOUT SUCCESS. AFTER THAT, 4 RETRIEVAL ATTEMPTS WERE MADE USING THE MERCI RETRIEVER V 2.5 FIRM FOLLOWED BY 1 RETRIEVAL ATTEMPT WITH THE MERCI RETRIEVER V 2.5. SOFT. THE V 2.5 SOFT DEVICE FRACTURED AND THE DISTAL DEVICE FRAGMENT WAS RETRIEVED USING A SNARE. THE PATIENT WAS LEFT WITH A PARTIAL OCCLUSION OF THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY AND NO FURTHER COMPLICATIONS. THE RETRIEVED DISTAL DEVICE FRAGMENT WAS RETURNED FOR EVALUATION. THE CORE WIRE FRACTURED JUST PROXIMAL FROM THE PROXIMAL END OF THE RETRIEVER HELIX. THE FRACTURE SURFACE WAS INDICATIVE OF A TORSIONAL FAILURE MODE. THE RETRIEVER IFU HAS A WARNING WITH RECOMMENDATIONS TO REDUCE THE RISK OF FRACTURE. THE PHYSICIAN INDICATED, THERE WAS PLAQUE IN THE VESSEL AND HE TORQUED THE RETRIEVER UP TO 5 REVOLUTIONS (UP TO BUT NOT BEYOND THE IFU WARNING LIMIT). HE ALSO INDICATED THAT HE MAINTAINED THE MICROCATHETER POSITION UP TO THE HELIX LOOPS AS RECOMMENDED IN AN IFU WARNING INTENDED TO PREVENT RISK OF FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 2.5 SOFT CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90111 33319

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other