BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETRIEVER V 2.5 FIRM

    MDR report key: 2642525 · Received July 2, 2012

    Report

    Report Number
    2954917-2012-00075
    Event Type
    Death
    Date Received
    July 2, 2012
    Date of Event
    July 7, 2011
    Report Date
    July 2, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K081305
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INSTRUCTIONS FOR USE LISTS RELATED POSSIBLE COMPLICATIONS. ALSO, WHILE THE CONCENTRIC MEDICAL DEVICE USE MAY HAVE CAUSED OR CONTRIBUTED TO THE PT OUTCOME, THERE ARE OTHER FACTORS INDEPENDENT OF THE SUBJECT DEVICE (E.G., PT 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 MFG RECORDS FOR THE MERCI RETRIEVER V 2.5 FIRM DEVICE COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    PT WAS A (B)(6) FEMALE WITH LEFT INTERNAL CAROTID ARTERY (ICA) OCCLUSION TWO PASSES WITH A MERCI RETRIEVER A V 2.5 FIRM AND ONE PASS WITH A MERCI RETRIEVER V 3.0 FIRM WERE MADE. PT HAD A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 0 AFTER PROCEDURE. V 3.0 FIRM RETRIEVER GOT STUCK AT THE DISTAL PORTION OF LEFT ICA. A CT SCAN REVEALED A SUBARACHNOID HEMORRHAGE (SAH). THE PT EXPERIENCED RESPIRATORY ARREST. A POST-OPERATIVE CT SCAN SHOWED EXTENSIVE BRAIN INFARCTION OF THE LEFT HEMISPHERE AS WELL AS SAH. A CT SCAN ON THE FOLLOWING DAY SHOWED DEVELOPMENT OF BRAIN EDEMA AND BRAIN HERNIA. REDUCTION OF BLOOD PRESSURE AND HEART RATE APPEARED AS THE BRAIN HERNIA WORSENED. THE PT EXPIRED ON (B)(6) 2011. DURING PROCEDURE, 40.2 MG OF TISSUE PLASMINOGEN ACTIVATOR (T-PA) WAS INTRAVENOUSLY ADMINISTERED TO THE PT. PHYSICIAN BELIEVES THAT THE SAH IS RELATED TO THE USE OF THE MERCI RETRIEVER. PHYSICIAN ALSO STATED THAT THE CAUSE OF PT'S OUTCOME IS EXTENSIVE CEREBRAL INFARCTION AND NOT RELATED TO THE SAH.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| O| R