BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI MICROCATHETER 18L

    MDR report key: 1816451 · Received August 19, 2010

    Report

    Report Number
    2954917-2010-00010
    Event Type
    Death
    Date Received
    August 19, 2010
    Date of Event
    November 23, 2009
    Report Date
    August 19, 2010
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQO
    PMA / PMN Number
    K003086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 PATIENT OUTCOME, THERE ARE OTHER FACTORS INDEPENDENT OF THE SUBJECT DEVICE (E.G., PATIENT FACTORS, DEVICE USE FACTORS, OTHER DEVICES EMPLOYED, DRUGS ADMINISTERED, ETC.) THAT ALSO MAY HAVE CAUSED OR CONTRIBUTED TO THE OUTCOME.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH RIGHT HEMIPARESIS AND DYSARTHRIA CAUSED BY OCCLUSIVE THROMBUS EXTENDING FROM THE PROXIMAL LEFT INTERNAL CAROTID ARTERY (ICA) TO THE LEFT MIDDLE CEREBRAL ARTERY. THE INTERVENTIONAL PROCEDURE WAS INITIATED ABOUT 8 HOURS AFTER SYMPTOM ONSET. SEVERAL INTRAVASCULAR DEVICES AND INTRA-ARTERIAL TPA INJECTIONS WERE INVOLVED WITH SEVERAL ATTEMPTS TO REMOVE THE OCCLUSIVE THROMBUS, WITH LIMITED SUCCESS. THE PHYSICIAN NOTED EXTRAVASATION OF CONTRAST WHICH THE PHYSICIAN ATTRIBUTED TO POSSIBLE PERFORATION OF THE LEFT ANTERIOR CHOROIDAL ARTERY WHEN ATTEMPTING TO ACCESS THE OCCLUDED SUPRACLINOID LEFT ICA USING THE X-CELERATOR 0.014" GUIDEWIRE (MANUFACTURED BY EV3, INC.) AND THE MICROCATHETER 18L. HEPARIN WAS REVERSED AND THE PROCEDURE WAS STOPPED. CT/MR IMAGING AT 24 HOURS REVEALED EXTRAVASCULAR BLOOD. THE (B)(6) WORSENED BY MORE THAN 4 POINTS AND HEMORRHAGE WAS IDENTIFIED AS THE PREDOMINANT CAUSE OF THE NEUROLOGIC DETERIORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI MICROCATHETER 18L CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CONCENTRIC MEDICAL, INC. 90044 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death