BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCI RETRIEVER K MINI

    MDR report key: 1511107 · Received October 12, 2009

    Report

    Report Number
    2954917-2009-00022
    Event Type
    Malfunction
    Date Received
    October 12, 2009
    Date of Event
    February 9, 2009
    Report Date
    October 12, 2009
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K061059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INSTRUCTION FOR USE INCLUDES A WARNING INTENDED TO REDUCE THE RISK OF FRACTURE.

    Description of Event or Problem · 1

    TERMINALLY ILL LUNG CANCER PT WAS IN HOSP FOR ABOUT 1 WEEK BEFORE EXPERIENCING ISCHEMIC STROKE. PT HAD EMBOLIC OCCLUSION OF THE PROXIMAL M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY. MULTIPLE ATTEMPTS WERE MADE TO REVASCULARIZE THE ARTERY, FIRST WITH PENUMBRA DEVICES, FOLLOWED BY A RETRIEVER K MINI DEVICE. REVASCULARIZATION WAS NOT ACHIEVED. THE K MINI DEVICE FRACTURED AFTER THE THIRD RETRIEVAL ATTEMPT, AND THE DEVICE FRAGMENT WAS RETAINED WITHIN THE EMBOLUS IN THE PROXIMAL M1 SEGMENT. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE FRAGMENT UTILIZING A FOREIGN BODY RETRIEVAL DEVICE; HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL, AS THE RETAINED FRAGMENT WAS DENSELY INTERTWINED AND ADHERENT TO THE EMBOLUS IN THE M1 SEGMENT. THE CASE NOTES OBTAINED FROM THE SITE INDICATED THE PT TOLERATED THE PROCEDURES WELL WITHOUT CHANGE IN HEMODYNAMIC OR NEUROLOGIC STATUS. THE PT DIED 7 DAYS AFTER THE PROCEDURE DATE. THE CAUSE OF DEATH WAS REPORTED TO BE RESPIRATORY FAILURE SECONDARY TO SMALL CELL LUNG CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER K MINI CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL, INC. 90092 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other