BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENDITUR LAA EXCLUSION SYSTEM

    MDR report key: 23244605 · Received October 8, 2025

    Report

    Report Number
    MW5176986
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    April 13, 2025
    Report Date
    October 2, 2025
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    PZX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TEE DEMONSTRATED FLOW INTO THE LEFT ATRIAL APPENDAGE AFTER LEFT ATRIAL APPENDAGE LIGATION CLIP WAS PLACED. AT TIME OF INSERTION, THE CLIP WAS PLACED AND THERE WAS NO FLOW INTO THE LEFT ATRIAL APPENDAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509475 PENDITUR LAA EXCLUSION SYSTEM LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE PZX MEDTRONIC PERFUSION SYSTEMS LAAC45 T4J029X

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other