BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP

    MDR report key: 16691483 · Received April 6, 2023

    Report

    Report Number
    3011706110-2023-00014
    Event Type
    Injury
    Date Received
    April 6, 2023
    Date of Event
    March 7, 2023
    Report Date
    April 6, 2023
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    UDI-DI
    10840143901225
    PMA / PMN Number
    K210293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AS THERE WAS NO REPORTED DEVICE MALFUNCTION. THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT 112045. THERE IS NOTHING IN THE DEVICE HISTORY RECORD THAT WOULD INDICATE THAT THE DEVICES WERE RELEASED WITH ANY NON-CONFORMANCES THAT WOULD CONTRIBUTE TO THE COMPLAINT.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT AN ON-PUMP, HEPARINIZED MINI MITRAL VALVE REPAIR WITH CONCOMITANT MAZE PROCEDURE AND LEFT ATRIAL APPENDAGE EXCLUSION. A PROV40 CLIP WAS PLACED SUCCESSFULLY. POST-OPERATIVE HEART CATHETERIZATION INDICATED THAT THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS OCCLUDED. PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE THE SURGEON PERFORMED A LEFT THORACOTOMY AND REMOVED THE PROV40 AND PLACED A BALLOON PUMP. HEART CATHETERIZATION THE NEXT DAY SHOWED THE LAD HAD NORMAL FLOW. THE PATIENT IS DOING WELL. 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
    1911951 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP FZP ATRICURE, INC. PROV40 112045 10840143901225

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| L