BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETRIEVER V 3.0 FIRM

    MDR report key: 2482979 · Received March 7, 2012

    Report

    Report Number
    2954917-2012-00008
    Event Type
    Death
    Date Received
    March 7, 2012
    Date of Event
    January 20, 2011
    Report Date
    March 7, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO EVIDENCE OF CONCENTRIC MEDICAL DEVICE MALFUNCTION AND THE DEVICE INSTRUCTIONS OF 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 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 3.0 FIRM DEVICE COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    PLEASE REFER TO MEDWATCH MANUFACTURER REPORT NUMBER 2954917-2012-00007. THIS REPORT IS FOR THE SECOND DEVICE INVOLVED IN THE CASE. PT WAS A (B)(6) MALE WITH A LEFT M1 OCCLUSION. PHYSICIAN MADE TWO PASSES WITH A MERCI RETRIEVER V 2.5 FIRM AND TWO PASSES WITH A MERCI RETRIEVER V 3.0 FIRM RESPECTIVELY. PT HAD A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 1 AFTER THE TREATMENT. FOLLOWING USE OF THE MERCI DEVICES, A DISSECTION AT THE LEFT M1 WAS NOTICED. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED FOR RECOVERY THAT RESULTED IN EXTRAVASATIONS FROM LEFT MIDDLE CEREBRAL ARTERY (MCA). THE PT DEVELOPED EXTENSIVE LEFT MCA INFARCTION THAT LED TO ASPIRATION PNEUMONITIS DUE TO DISTURBANCE OF CONSCIOUSNESS. PT WAS TREATED WITH ANTIBIOTICS FOR THE ASPIRATION PNEUMONIA. A 29.0 MG OF TISSUE PLASMINOGEN ACTIVATOR (T-PA) WAS ADMINISTERED TO THE PT. PT EXPIRED ON (B)(6) 2011. PHYSICIAN BELIEVES THAT THE DISSECTION AT LEFT-M1 WAS DUE TO THE USE OF THE MERCI DEVICES AND THAT THE PT OUTCOME WAS DUE TO WORSENING OF THE CEREBRAL INFARCTION AND NOT RELATED TO THE MERCI DEVICES.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R