BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCI RETRIEVER L6

    MDR report key: 1375330 · Received February 19, 2009

    Report

    Report Number
    2954917-2009-00007
    Event Type
    Malfunction
    Date Received
    February 19, 2009
    Date of Event
    February 10, 2009
    Report Date
    February 18, 2009
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K071172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE MERCI RETRIEVER L6 WAS DEPLOYED IN THE M1 BRANCH OF THE LEFT MCA. DURING THE FIRST ATTEMPT TO RETRIEVE THE CLOT, THE DISTAL PORTION OF THE RETRIEVER FRACTURED. THE PHYSICIAN INDICATED THAT HE DID NOT TORQUE THE RETRIEVER, AND THE MICROCATHETER 18L WAS PLACED JUST PROXIMAL TO THE PROXIMAL HELIX LOOP. HE ALSO INDICATED THAT HE BELIEVED THE RETRIEVER FRACTURED JUST PROXIMAL TO THE PROXIMAL HELIX LOOP. THE DETACHED TIP WAS LOCATED IN THE MCA PROXIMAL M1. THE PHYSICIAN SUCCESSFULLY REMOVED THE RETRIEVER TIP FROM THE PT USING A SNARE DEVICE. HE THEN CONTINUED THE STROKE INTERVENTION BY DEPLOYING ADDITIONAL MERCI RETRIEVERS. HE WAS ABLE TO RESTORE FLOW IN THE TARGETED VESSELS AND THE CASE WAS ANGIOGRAPHICALLY SUCCESSFUL. NO PT COMPLICATIONS WERE REPORTED. SINCE THE DEVICE WAS NOT RETURNED TO CONCENTRIC MEDICAL, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THE DEVICE INSTRUCTIONS FOR USE (IFU) INCLUDES A WARNING THAT PROVIDES RECOMMENDATIONS TO REDUCE THE RISK OF FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER L6 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL, INC. 90060 33198

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention