BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCI RETRIEVER L6

    MDR report key: 1289516 · Received January 14, 2009

    Report

    Report Number
    2954917-2008-00023
    Event Type
    Injury
    Date Received
    January 14, 2009
    Date of Event
    July 10, 2007
    Report Date
    January 14, 2009
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K071172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NONE OF THE REPORTED INFORMATION SUGGESTED THAT ANY CONCENTRIC MEDICAL DEVICE MALFUNCTIONED. THE CURRENT DEVICE INSTRUCTIONS FOR USE (IFC) LISTS VESSEL PERFORATION AS KNOWN COMPLICATIONS. ALSO, THERE IS A WARNING IN THE IFU THAT PROVIDES RECOMMENDATIONS TO PREVENT VESSEL DAMAGE. BECAUSE THE DEVICE WAS NOT RETURNED TO CONCENTRIC MEDICAL, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    A CONCENTRIC EMPLOYEE FIRST BECAME AWARE OF THIS EVENT IN LATE 2008, WHEN REVIEWING MERCI REGISTRY PROCEDURE NOTES RECORDED BY THE SITE. MC18L MICROCATHETER ALONG WITH BOSTON SCIENTIFIC TRANSEND GUIDEWIRE WAS ADVANCED TO THE MIDDLE CEREBRAL ARTERY. FIRST CLOT RETRIEVAL ATTEMPT WITH RETRIEVER L6: MINIMAL FLOW IMPROVEMENT. SECOND RETRIEVAL ATTEMPT WITH RETRIEVER L6: MILD FLOW IMPROVEMENT. 7 MG OF TPA THROMBOLYSIS AGENT WAS SLOWLY INFUSED INTO MCA WITH SOME IMPROVEMENT. THIRD AND FOURTH RETRIEVAL ATTEMPTS WITH RETRIEVAL L6: FURTHER IMPROVEMENT. WHEN PREPARING FOR 5TH RETRIEVER PASS, WHEN CATHETER WAS PLACED IN THE MCA, AN ANGIOGRAM SHOWED SOME EXTRAVASATION OF CONTRAST AND NO FURTHER RETRIEVAL ATTEMPTS WERE PERFORMED AND NO MORE TPA WAS INFUSED. IMPRESSION: PARTIALLY SUCCESSFUL RETRIEVAL OF RIGHT MIDDLE CEREBRAL ARTERY CLOT WITH THROMBOLYSIS. AT END OF PROCEDURE, THERE WAS SOME EXTRAVASATION IN THE MIDDLE CEREBRAL ARTERY TERRITORY. THE PATIENT ULTIMATELY DIED 2 DAYS POST PROCEDURE DUE TO THE STROKE AND ACUTE MI. PATIENT HAD A DNR ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER L6 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL, INC. 90060 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other