BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT

    MDR report key: 22035259 · Received May 16, 2025

    Report

    Report Number
    22035259
    Event Type
    Death
    Date Received
    May 16, 2025
    Date of Event
    April 16, 2025
    Report Date
    May 8, 2025
    Manufacturer
    ABBOTT
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025 A 74-YEAR-OLD PATIENT HAD A LEFT ATRIAL APPENDAGE CLOSURE WITH AN AMULET CLOSURE DEVICE. THE PATIENT WAS STABLE AFTER THE PROCEDURE AND DISCHARGED THE SAME DAY. THE PATIENT EXPIRED LATER THAT NIGHT. THE PRESUMED CAUSE OF DEATH WAS EROSION OF THE LEFT ATRIAL APPENDAGE ON THE PULMONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182900 ABBOTT 28 MM WATCHMAN AMPLATZER AMULET LAA CLOSSURE DEVICE NGV ABBOTT AM28 10388008

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death