BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI MICROCATHETER 18L

    MDR report key: 2621265 · Received June 11, 2012

    Report

    Report Number
    2954917-2012-00045
    Event Type
    Death
    Date Received
    June 11, 2012
    Date of Event
    May 9, 2012
    Report Date
    June 11, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQO
    PMA / PMN Number
    K003086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE DEVICE WAS NOT RETURNED TO CONCENTRIC MEDICAL, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    PATIENT WAS A (B)(6) FEMALE WITH A MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION. PHYSICIAN USED A MERCI (MC 18L WITH A PENUMBRA 041 AND CHIKAI 14 MICRO GUIDEWIRE) TO TRY TO REMOVE THE CLOT. PHYSICIAN FIRST INSERTED MC 18L AND CHIKAI 14 AND BROUGHT THEM UP TO M2, THEN INTRODUCED PENUMBRA 041 UP TO M1 DISTAL BIFURCATION OF MCA. PHYSICIAN TREATED THE EXTRAVASATION WITH EMBOLIZATION COIL. THE PATIENT EXPIRED A DAY AFTER PROCEDURE DUE TO SUBARACHNOID HEMORRHAGE (SAH). THE RELATION BETWEEN THE EXTRAVASATION AND SAH IS UNKNOWN. THE PHYSICIAN BELIEVES THAT THE CAUSE OF THE EXTRAVASATION IS ATTRIBUTED TO THE USE OF PENUMBRA 041. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI MICROCATHETER 18L CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CONCENTRIC MEDICAL, INC. 90044 35626

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| O| R