BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    AMPLATZER AMULET

    MDR report key: 23875653 · Received December 23, 2025

    Report

    Report Number
    2135147-2025-07617
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    April 22, 2022
    Report Date
    December 23, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    PMA / PMN Number
    P200049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) EVENTS OF PERI-DEVICE LEAK WERE REPORTED IN THE CURRENT REPORTING PERIOD. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS LIMITED INFORMATION WAS PROVIDED INCLUDING THAT THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LIMITED INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, RISK ASSESSMENT WAS COMPLETED FOR THE REPORTED INCIDENTS. (B)(4) SUBJECTS EXPERIENCED PERI-DEVICE LEAK SINCE THE BEGINNING OF THE REGISTRY AT A FOLLOW UP VISIT. THE EVENT OF PERI-DEVICE LEAK AND RATES REPORTED IN THIS STUDY WERE FOUND TO BE ANTICIPATED IN THE STUDY POPULATION AND ARE IN ALIGNMENT WITH RATES OBSERVED IN OTHER CLINICAL STUDIES. NO NEW RISKS HAVE BEEN IDENTIFIED FOR THIS POPULATION. NO NEW HAZARDS OR HARMS WERE IDENTIFIED THAT WOULD IMPACT THE BENEFIT/RISK PROFILE. BASED ON A REVIEW OF THE AVAILABLE INFORMATION, THERE WAS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING. THEREFORE, NO REMEDIAL ACTION IS REQUIRED AT THIS TIME. B3 - DATE OF EVENT: THE EARLIEST EVENT DATE WAS USED. D4 - PRIMARY UDI NUMBER: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. D6A - IMPLANT DATE: THE EARLIEST IMPLANT DATE WAS USED. THIS REPORT IS FOR QUARTER 4 TIMEFRAME BETWEEN 01 OCTOBER 2025 - 31 DECEMBER 2025.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH AMULET LAAO REGISTRY DATA THAT AMPLATZER AMULET DEVICES MAY BE RELATED TO (B)(4) PERI-DEVICE LEAK ADVERSE EVENTS WHICH ARE CONSIDERED MALFUNCTION. THE RELATIONSHIP OF THE ADVERSE EVENTS 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 (B)(6) 2021 ¿ (B)(6) 2023. PATIENTS¿ MEAN AGE IS 78 YEARS, RANGING FROM 49 - (B)(6) YEARS. 61% OF THE PATIENTS WERE MALE, 39% OF THE PATIENTS WERE FEMALE. THIS REPORT IS FOR QUARTER 4 TIMEFRAME BETWEEN 01 OCTOBER 2025 - 31 DECEMBER 2025. AS OF 03 OCTOBER 2025, (B)(4) PATIENTS WERE TREATED WITH THE AMULET DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2702250 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL UNK AMPLATZER AMULET

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male