BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETRIEVER V 2.0 SOFT

    MDR report key: 2621264 · Received June 11, 2012

    Report

    Report Number
    2954917-2012-00046
    Event Type
    Death
    Date Received
    June 11, 2012
    Date of Event
    November 5, 2011
    Report Date
    June 11, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K082034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. BECAUSE THE DEVICE WAS NOT RETURNED TO CONCENTRIC MEDICAL, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. ALSO, BECAUSE THE LOT NUMBER FOR THE DEVICE WAS NOT REPORTED TO CONCENTRIC MEDICAL, THE MANUFACTURING RECORDS FOR THE MERCI RETRIEVER V 2.0 SOFT DEVICE COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    PATIENT WAS A (B)(6) FEMALE WITH A RIGHT INTERNAL CAROTID ARTERY (ICA) AND RIGHT MIDDLE CEREBRAL ARTERY (MCA) M1 OCCLUSION. PHYSICIAN MADE ONE PASS WITH A MERCI RETRIEVER V 2.0 SOFT, ONE PASS WITH A MERCI RETRIEVER V 2.5 FIRM AND ONE PASS WITH A V 3.0 FIRM. PATIENT HAD A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2B AFTER TREATMENT. ONE DAY POST PROCEDURE, COMPUTED TOMOGRAPHY SCAN REVEALED A SUBARACHNOID HEMORRHAGE (SAH) AT SYLVIAN FISSURE OF RIGHT HEMISPHERE. PATIENT DEVELOPED AN EXTENSIVE BRAIN EDEMA OF RIGHT HEMISPHERE AND EXPIRED ON (B)(6) 2011. TISSUE PLASMINOGEN ACTIVATOR WAS NOT ADMINISTERED. HEPARIN DOSAGE WAS REDUCED AS MEDICAL INTERVENTION. PHYSICIAN BELIEVES THAT THE SAH IS ATTRIBUTED TO THE HEMORRHAGIC INFARCTION. PHYSICIAN STATED THAT THE PATIENT'S OUTCOME IS DUE TO CEREBRAL EDEMA FROM INADEQUATE RECANALIZATION. PHYSICIAN ALSO BELIEVES THAT THE SAH ALSO CONTRIBUTED TO THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 2.0 SOFT CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90109 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| O| R