BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCI RETRIEVER V 2.5 FIRM

    MDR report key: 1327461 · Received February 25, 2009

    Report

    Report Number
    2954917-2009-00008
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    February 4, 2009
    Report Date
    February 23, 2009
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K081305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NONE OF THE REPORTED INFORMATION SUGGESTED THAT ANY CONCENTRIC MEDICAL DEVICE MALFUNCTIONED. BECAUSE THE DEVICE WAS NOT RETURNED TO CONCENTRIC MEDICAL, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. EMBOLI, ACUTE OCCLUSION, ISCHEMIA AND NEUROLOGICAL DEFICITS INCLUDING STROKE ARE LISTED AS POSSIBLE COMPLICATIONS IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    A FEMALE PATIENT (HEMIPLEGIC) PRESENTED WITH MI OCCLUSION. FULL RECANALIZATION WAS ACHIEVED IN THE MCA AFTER ONE PASS WITH MERCI RETRIEVER V 2.5 FIRM AND DISTAL ACCESS CATHETER. HOWEVER, PROXIMAL ACA A2 WAS EMBOLIZED DURING THE CLOT RETRIEVAL. THIS VESSEL WAS OPEN DURING PRE RETRIEVAL ANGIO AND WAS AN UNINVOLVED TERRITORY BEFORE CLOT RETRIEVAL. DR. DECIDED TO LEAVE CLOT IN A2 DUE TO DIFFICULTY OF USING MERCI IN A2. PATIENT WAS INELIGIBLE FOR LYTICS DUE TO SUBDURAL HEMATOMA SUFFERED DURING FALL CAUSED BY THE SYMPTOM ONSET. THE PHYSICIAN CONSIDERS THIS A 'WIN' AND A GOOD ANGIOGRAPHIC RESULT. HE FELT THAT RECANALIZING MCA OUTWEIGHS LOSS OF EMBOLIZING ACA TERRITORY. HE FELT THAT EVEN THOUGH THIS PATIENT WILL GO ON TO HAVE A STROKE, MCA RECANALIZATION WILL GIVE HER THE BEST CHANCE TO AVOID MORTALITY AND LIVE WITH FEWER DISABILITIES IF HE WAS NOT TO HAVE OPENED THE MCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 2.5 FIRM CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90112 33388

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other