BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 6024516 · Received October 12, 2016

    Report

    Report Number
    3003502395-2016-00127
    Event Type
    Injury
    Date Received
    October 12, 2016
    Report Date
    September 13, 2016
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER THE DEVICE HISTORY REVIEW WAS UNABLE TO BE COMPLETED AS THE RELEVANT DEVICE LOT/SERIAL NUMBER WAS NOT REPORTED OR ABLE TO BE SUBSEQUENTLY ASCERTAINED. THE COMPLAINT COULD NOT BE CONFIRMED. DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A PATIENT, APPROXIMATELY THREE YEARS EARLIER HAD AN AVR / MAZE / ATRICLIP PLACEMENT. THEY THEN PRESENTED TO THE ER EARLIER IN THE SUMMER OF 2016 WITH AORTIC VALVE ENDOCARDITIS. BLOOD CULTURES WERE DONE AND CAME BACK POSITIVE. AT THAT TIME, THE ATRICLIP WAS EXPLANTED AND CULTURED, THE CULTURES CAME BACK POSITIVE. THE CULTURES FROM THE PERICARDIUM CAME BACK NEGATIVE. THE EXTENT OF THE PERICARDIAL INFECTION WAS LIMITED TO THE LAA. THE CURRENT STATUS OF THE PATIENT IS LIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672877 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP UNKNOWN FZP ATRICURE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R