BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIP¿ LAA EXCLUSION SYSTEM WITH PRELOADED V-CLIP

    MDR report key: 19084724 · Received April 10, 2024

    Report

    Report Number
    3011706110-2024-00026
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 17, 2024
    Report Date
    April 10, 2024
    Manufacturer
    ATRICURE, INC.
    Product Code
    PZX
    PMA / PMN Number
    K210293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE CONDUCTED AS THE LOT NUMBER FOR THE DEVICE WAS NOT REPORTED OR ABLE TO BE ASCERTAINED.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A SUCCESSFUL VIDEO-ASSISTED THORACOSCOPIC (VATS) LEFT ATRIAL APPENDAGE EXCLUSION (LAAE) USING A PROV45 ATRICLIP DEVICE. AFTERWARD, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). WHILE IN THE ICU, THE PATIENT EXPERIENCED BLEEDING, WITH APPROXIMATELY 400CC OF BLOOD ACCUMULATING IN THEIR PERICARDIAL DRAIN. CONSEQUENTLY, THE PATIENT RETURNED TO THE OPERATING ROOM FOR FURTHER INVESTIGATION. THE SURGICAL TEAM IDENTIFIED AND REPAIRED A TEAR ON THE ATRIUM USING SURGICEL. THE SURGEON SUSPECTS THAT THE PATIENT¿S FRIABLE TISSUE AND PRESSURE FROM COUGHING MAY HAVE ALSO CONTRIBUTED TO THE TEAR. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062942 ATRICLIP¿ LAA EXCLUSION SYSTEM WITH PRELOADED V-CLIP IMPLANTABLE CLIP AND CLIP APPLIER PZX ATRICURE, INC. PROV45 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Life Threatening| R