BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED V-CLIP

    MDR report key: 20043425 · Received August 22, 2024

    Report

    Report Number
    3011706110-2024-00050
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 22, 2024
    Manufacturer
    ATRICURE, INC.
    Product Code
    PZX
    UDI-DI
    10840143907647
    PMA / PMN Number
    K210293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION HOWEVER, A DEVICE HISTORY REVIEW WAS CONDUCTED AND THERE IS NOTHING IN THE PRODUCT HISTORY RECORD THAT WOULD INDICATE THAT THE DEVICES WERE RELEASED WITH ANY NON-CONFORMANCES THAT WOULD CONTRIBUTE TO THE SUBJECT COMPLAINT.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A CONVERGENT PROCEDURE WITH CONCOMITANT VIDEO-ASSISTED THORACOSCOPIC (VATS) LEFT ATRIAL APPENDAGE EXCLUSION (LAAE) USING A PROV45 ATRICLIP DEVICE. DURING PLACEMENT OF THE CLIP DEVICE, AN INJURY OCCURRED AT THE BASE OF THE LEFT ATRIAL APPENDAGE (LAA). THE PROCEDURE WAS CONVERTED TO STERNOTOMY AND THE INJURY WAS REPAIRED WITH SUTURE. THE PROV45 WAS THEN SUCCESSFULLY PLACED AT THE BASE OF THE LAA. THE PATIENT IS REPORTEDLY RECOVERING. 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
    1363937 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED V-CLIP IMPLANTABLE CLIP AND CLIP APPLIER PZX ATRICURE, INC. PROV45 136668 10840143907647

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| L