BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETRIEVER V 3.0 FIRM

    MDR report key: 2426110 · Received January 13, 2012

    Report

    Report Number
    2954917-2012-00001
    Event Type
    Death
    Date Received
    January 13, 2012
    Date of Event
    July 14, 2011
    Report Date
    January 13, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS FOR MERCI RETRIEVER V 3.0 FIR, LOT NUMBER, 34642, WERE REVIEWED AND NO ANOMALIES WERE FOUND THAT ARE RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    PATIENT WAS AN (B)(6) YEAR OLD FEMALE THAT DEVELOPED A SUBARACHNOID HEMORRHAGE (SAH) INTRA PROCEDURE. PATIENT EXPIRED TWO DAYS POST PROCEDURE. PER PHYSICIAN IT IS UNKNOWN WHETHER THE MERCI DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE SAH. IT IS ALSO UNKNOWN WHETHER THE MERCI RETRIEVER V 3.0 FIRM MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. THERE WAS NO EVIDENCE OF CONCENTRIC MEDICAL DEVICE MALFUNCTION AND THE DEVICE INSTRUCTIONS FOR USE LISTS RELATED POSSIBLE COMPLICATIONS. ALSO, WHILE THE CONCENTRIC MEDICAL DEVICE USE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT OUTCOME, THERE ARE OTHER FACTORS INDEPENDENT OF THE SUBJECT DEVICE (E.G., PATIENT FACTORS, DEVICE USE FACTORS, OTHER DEVICES EMPLOYED, DRUGS ADMINISTERED, ETC.) THAT ALSO MAY HAVE CAUSED OR CONTRIBUTED TO THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 3.0 FIRM CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90113 34642

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death