BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    AMPLATZER AMULET

    MDR report key: 17406650 · Received July 27, 2023

    Report

    Report Number
    2135147-2023-03275
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    June 30, 2022
    Report Date
    July 27, 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

    AMULET LAAO REGISTRY DATA REPORTS 6 PATIENTS WITH DEVICE SYSTEMIC EMBOLIZATION WITH SURGICAL RETRIEVAL AND DEVICE SYSTEMIC EMBOLIZATION WITH CATHETER RETRIEVAL. NO DEVICES WERE RETURNED. 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. D6A - IMPLANT DATE: THE EARLIEST IMPLANT DATE WAS USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH AMULET LAAO REGISTRY DATA THAT AMPLATZER AMULET DEVICES MAY BE RELATED TO 6 DEVICE SYSTEMIC EMBOLIZATION WITH SURGICAL RETRIEVAL AND DEVICE SYSTEMIC EMBOLIZATION WITH CATHETER RETRIEVAL ADVERSE EVENTS WHICH ARE CONSIDERED SERIOUS INJURY. THE RELATIONSHIP OF THE SERIOUS INJURY TO THE AMPLATZER AMULET DEVICES COULD NOT BE DETERMINED BASED ON THE LIMITED DATA RECEIVED FROM THE REGISTRY. AMULET 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 30 JUN. 2022 ¿ 27 SEP. 2022. PATIENTS¿ MEAN AGE IS 82 YEARS, RANGING FROM 75 - 87 YEARS. 50% OF THE PATIENTS WERE MALE, 50% OF THE PATIENTS WERE FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322771 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other