BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETRIEVAL SYSTEM

    MDR report key: 1083582 · Received July 30, 2008

    Report

    Report Number
    1083582
    Event Type
    Death
    Date Received
    July 30, 2008
    Date of Event
    March 3, 2008
    Report Date
    July 22, 2008
    Manufacturer
    CONTENTRIC MEDICAL
    Product Code
    NRY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADMITTED WITH ACUTE ONSET OF APHASIA AND RIGHT HEMIPARESIS SECONDARY TO ACUTE LEFT MIDDLE CEREBRAL ARTERY TERRITORY INFARCT. PATIENT UNDERWENT A CEREBRAL ANGIOGRAM, DURING PROCEDURE A MERCI RETRIEVAL DEVICE WAS UTILIZED TO REMOVE THE ANTERIOR AND MIDDLE CEREBRAL ARTERY THROMBUS. UPON REMOVAL OF THE MERCI RETRIEVAL DEVICE THE DISTAL TIP FRACTURED WITHIN THE THROMBUS. TWO ATTEMPTS WERE MADE TO RETRIEVE THE FRACTURED WIRE, BOTH UNSUCCESSFUL. POST CT SCAN OBTAINED AND CONFIRMED RETAINED TIP OF MERCI RETRIEVAL DEVICE IN LEFT MIDDLE CEREBRAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVAL SYSTEM MERCI L5 REVIEVAL SYSTEM NRY CONTENTRIC MEDICAL 90050

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death| O