BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 18011403 · Received October 26, 2023

    Report

    Report Number
    2135147-2023-04666
    Event Type
    Injury
    Date Received
    October 26, 2023
    Date of Event
    January 10, 2023
    Report Date
    October 26, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF PLEURAL EFFUSION WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS NO ADDITIONAL INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH LEFT ATRIAL APPENDAGE OCCLUDER (LAAO) REGISTRY DATA THAT AMPLATZER AMULET DEVICES MAY BE RELATED TO 8 PLEURAL EFFUSION ADVERSE EVENTS WHICH ARE CONSIDERED SERIOUS INJURY. THE RELATIONSHIP OF THE ADVERSE EVENTS TO THE AMPLATZER AMULET DEVICES COULD NOT BE DETERMINED BASED ON THE LIMITED DATA RECEIVED FROM THE REGISTRY. LEFT ATRIAL APPENDAGE OCCLUDER (LAAO) REGISTRY DATA IS REPORTED AS A SUMMARY PER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - GEN2201026. THE DATA RECEIVED INDICATED THAT THE PROCEDURE DATE RANGE WAS BETWEEN 10 JANUARY 2023 ¿ 27 JUNE 2023. PATIENTS¿ MEAN AGE IS 83 YEARS, RANGING FROM 73 - 90 YEARS. 37% OF THE PATIENTS WERE MALE, 63% OF THE PATIENTS WERE FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000256 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown Other