BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 11699539 · Received April 21, 2021

    Report

    Report Number
    3011706110-2021-00017
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 21, 2021
    Manufacturer
    ATRICURE, INC.
    Product Code
    PZX
    PMA / PMN Number
    K191413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CASE (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED. THERE WAS NOTHING IN THE DEVICE HISTORY RECORD THAT WOULD INDICATED THAT THE DEVICES WERE RELEASED WITH ANY NON-CONFORMANCES THAT WOULD CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT ON (B)(6) 2021 A PATIENT UNDERWENT AN ON-PUMP MINIMALLY INVASIVE MITRAL VALVE PROLAPSE, TRICUSPID ANNULOPLASTY AND MAZE PROCEDURES WITH LEFT ATRIAL APPENDAGE MANAGEMENT. AFTER THE COMPLETION OF THE PROCEDURES, PATIENT WENT INTO VENTRICULAR FIBRILLATION. A TRANSESOPHAGEAL ECHOCARDIOGRAM CONFIRMED THAT THE POSTERIOR WALL OF THE LEFT ATRIUM WAS NOT FUNCTIONING NORMALLY AND THERE WAS NO FLOW TO THE LEFT CIRCUMFLEX ARTERY. THE SURGEON OPTED TO REMOVE THE PRO140 ATRICLIP FROM THE LEFT ATRIAL APPENDAGE AND A TRANSESOPHAGEAL ECHOCARDIOGRAM CONFIRMED FLOW WAS RESTORED TO THE LEFT CIRCUMFLEX ARTERY AS WELL AS THE POSTERIOR WALL. 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
    601485 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP PZX ATRICURE, INC. PRO140 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention