BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETRIEVER V 2.5 SOFT

    MDR report key: 1292346 · Received January 16, 2009

    Report

    Report Number
    2954917-2009-00001
    Event Type
    Death
    Date Received
    January 16, 2009
    Date of Event
    January 9, 2009
    Report Date
    January 14, 2009
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K081305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NONE OF THE REPORTED INFO SUGGESTED THAT ANY CONCENTRIC MEDICAL DEVICE MALFUNCTIONED. BECAUSE THE DEVICE WAS NOT RETURNED TO CONCENTRIC MEDICAL, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THE CURRENT DEVICE INSTRUCTIONS FOR USE (IFU) LISTS VESSEL DISSECTION 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 FEMALE PRESENTED WITH AN M1/M2 OCCLUSION. VERY TORTUOUS ICA SIPHON MADE THIS A VERY TOUGH CASE. A TOTAL OF 3 RETRIEVAL ATTEMPTS WERE MADE USING 2 MERCI RETRIEVER V 2.5 SOFT DEVICES, RESULTING IN PARTIAL RECANALIZATION OF THE VESSEL. INTRA-ARTERIAL TPA WAS ALSO USED. THE SUPERIOR DIVISION OF THE M2 ENDED UP WITH A DISSECTION. THE PHYSICIAN FELT THAT THE USE OF THE MERCI RETRIEVER V 2.5 SOFT CONTRIBUTED TO THE DISSECTION; NOT DUE TO POOR PERFORMANCE BUT JUST AN UNFORTUNATE CIRCUMSTANCE. THE DISSECTION LED TO A HEMORRHAGE THAT THE PHYSICIAN BELIEVED CONTRIBUTED TO THE PT'S DEATH 12 HRS AFTER THE PROCEDURE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death