BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONCENTRIC MERCI RETRIEVER X6

    MDR report key: 754817 · Received August 17, 2006

    Report

    Report Number
    MW1040088
    Event Type
    Other
    Date Received
    August 17, 2006
    Date of Event
    July 21, 2006
    Report Date
    August 11, 2006
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FEMALE PRESENTED WITH LEFT HEMISPERIC STROKE, S/P HYSTERECTOMY 5 DAYS PRIOR TO PROCEDURE. PATIENT WAS NOT A CANDIDATE FOR THROMBOLYTIC THERAPY FOR THIS REASON. ANGIOGRAM WAS PERFORMED THAT SHOWED CLOT OCCLUSION AT THE LEFT INTERNAL CAROTID BIFURCATION. ATTEMPTS WERE MADE WITH THE L5 RETRIEVER, BUT WOULD NOT GRAB THE CLOT. THE MERCI X6 WAS THEN INTRODUCED AND WAS ADVANCED INTO THE VESSEL AND TORQUING OF THE UNIT TO GET IT POSITIONED INTO THE CLOT WAS DONE. WHEN PULLING BACK ON THE UNIT IT WAS VISUALIZED UNDER FLUORO THAT THE CATHETER TIP WAS NOT COMING BACK AS THE BACKEND OF THE SYSTEM WAS BEING WITHDRAWN BY THE PHYSICIAN. FOLLOW UP X-RAY AND CONTRAST INJECTIONS UNDER FLUORO SHOWED THE RETAINED TIP FRAGMENT FOR THE RETRIEVER WITHIN THE CLOT FORMATION AND HAD NOT MOVED. MULTIPLE ATTEMPTS WERE MADE WITH ANOTHER X6 DEVICE AS WELL AS OTHER RETRIEVAL SNARES TO ATTEMPT TO RETRIEVE THE BROKEN FRAGMENT. THE PROCEDURE WAS THEN STOPPED BECAUSE THE CLOT COULD NOT BE RETRIEVED. IMAGES WERE TAKEN FOR DOCUMENTATION OF THE BROKEN DEVICE IN THE PATIENT'S VESSEL. PATIENT'S ATTENDING PHYSICIAN AS WELL AS THE INTERVENTIONAL NEURO-RADIOLOGIST WAS PRESENT FOR THE ENTIRE PROCEDURE AND THEN MADE THE FAMILY AWARE THAT A PIECE OF THE DEVICE WAS LEFT IN THE PATIENT AND THAT THEY WERE UNABLE TO REMOVE, THE CLOT AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCENTRIC MERCI RETRIEVER X6 SAME DQY CONCENTRIC MEDICAL, INC. 90066 32397

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other MICROVENA 4MM SIZE SNARES| MICROVENA 2MM