BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCI RETRIEVER V 2.5 FIRM

    MDR report key: 1664684 · Received April 16, 2010

    Report

    Report Number
    2954917-2010-00006
    Event Type
    Injury
    Date Received
    April 16, 2010
    Date of Event
    February 26, 2010
    Report Date
    April 16, 2010
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K081305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE MALFUNCTIONS WERE REPORTED. THE RETRIEVER INSTRUCTIONS FOR USE (IFU) LISTS VESSEL PERFORATION, INTRACRANIAL HEMORRHAGE, NEUROLOGICAL DEFICITS INCLUDING STROKE; AND DEATH AS A POSSIBLE COMPLICATIONS. THE IFU ALSO CONTAINS A WARNING THAT PROVIDES RECOMMENDATIONS TO REDUCE THE RISK OF VESSEL DAMAGE.

    Description of Event or Problem · 1

    PT PRESENTED WITH ACUTE OCCLUSION OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) M1/M2 JUNCTION. A MECHANICAL THROMBECTOMY PROCEDURE USING A MERCI RETRIEVER V 2.5 FIRM IN COMBINATION WITH A PENUMBRA ASPIRATION CATHETER AND INTRA-ARTERIAL TPA INFUSION. AFTER THE SECOND RETRIEVAL ATTEMPT, WHICH RESULTED IN PARTIAL RECANALIZATION OF THE VESSEL, IT WAS NOTED THAT THERE WAS AN EXTREME ACUTE ANGULATION IN THE M1/M2 VESSELS. THE THIRD RETRIEVAL ATTEMPT RESULTED IN SIGNIFICANTLY BETTER PERFUSION AT THE ACUTE BEND WITH INCREASED PERFUSION OF THE M3 VESSELS. A SMALL AREA OF EXTRAVASATION WAS SEEN IN THE PROXIMAL M2 VESSEL. THE TPA INFUSION (10 MG TOTAL INFUSION) WAS DISCONTINUED WHEN THE EXTRAVASATION WAS SEEN. THE PHYSICIAN INDICATED THE EXTRAVASATION WAS LIKELY DUE TO THE MERCI DEVICE'S TRACTION ON THE ARTERY. THE PROCEDURE WAS TERMINATED SO AS TO NOT EXACERBATE THE AREA OF HEMORRHAGE. THE LAST CEREBRAL ANGIOGRAM SHOWED NO SIGNIFICANT ACUTE HEMORRHAGE. THE 24 HOUR CT SHOWED EXTRAVASCULAR BLOOD. SITE PERSONNEL INDICATED THE HEMORRHAGE MAY HAVE CONTRIBUTED TO THE NEUROLOGICAL DETERIORATION OF THE PT. THE BASELINE NIHSS SCORE WAS 7. THE NIHSS SCORE 24 HOURS POST-PROCEDURE WAS 9. THE SITE'S PROCEDURE NOTES INDICATED THAT DUE TO THE EXTREME TORTUOSITY OF THIS VESSEL, MECHANICAL THROMBECTOMY IS EXTREMELY DIFFICULT AS PULLING THE DEVICE THROUGH THIS KINK CAN BE EXTREMELY DIFFICULT. THE NOTES ALSO INDICATED THAT DESPITE THIS UNFAVORABLE ANATOMY, MECHANICAL THROMBECTOMY WAS PERFORMED AND THERE WAS SIGNIFICANT PARTIAL RECANALIZATION OF THE MIDDLE CEREBRAL VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 2.5 FIRM CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90112 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other