BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETRIEVER V 2.0 FIRM

    MDR report key: 2492661 · Received March 13, 2012

    Report

    Report Number
    2954917-2012-00020
    Event Type
    Death
    Date Received
    March 13, 2012
    Date of Event
    December 7, 2010
    Report Date
    March 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

    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 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 2.0 FIRM DEVICE COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    PT WAS AN (B)(6) FEMALE WITH A RIGHT M2 MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION. ONE PASS WAS MADE WITH A MERCI RETRIEVER V 2.0 FIRM RESULTING IN A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2B. DIFFUSE BLEEDING-SUBARACHNOID HEMORRHAGE (SAH) WAS CONFIRMED AT IMMEDIATE POST-OPERATIVE CT SCAN. EXTERNAL VENTRICULAR DRAINAGE WAS PERFORMED FOR THE SAH. THE PT BECAME BEDRIDDEN FROM SAH AND DEVELOPED AN ASPIRATION PNEUMONITIS AND EXPIRED ON (B)(6) 2011. TISSUE PLASMINOGEN ACTIVATOR (T-PA) WAS NOT USED DURING THE CASE. PHYSICIAN BELIEVES THAT THE MERCI DEVICE CAUSED THE SAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 2.0 FIRM CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90110 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| O| R