BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 24235574 · Received February 2, 2026

    Report

    Report Number
    2135147-2026-00572
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    September 1, 2011
    Report Date
    February 2, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NA. THE DEVICE REMAINS IMPLANTED IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    THE ARTICLE, "LEFT ATRIAL APPENDAGE CLOSURE IN PATIENTS WITH HEREDITARY HEMORRHAGIC TELANGIECTASIA AND ATRIAL FIBRILLATION: A PROSPECTIVE STUDY AND SYSTEMATIC REVIEW", WAS REVIEWED. THIS RESEARCH ARTICLE IS A PROSPECTIVE SINGLE-CENTER EXPERIENCE TO EVALUATE THE EFFICACY AND SAFETY OF PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE (LAAC) WITH A SIMPLIFIED REGIMEN IN HEREDITARY HEMORRHAGIC TELANGIECTASIA (HHT) PATIENTS AND COMPARE THE RESULTS WITH WHAT HAD BEEN PREVIOUSLY REPORTED. THE DEVICES INCLUDED IN THIS STUDY WERE AMPLATZER AMULET AND WATCHMAN. THE ARTICLE CONCLUDED THAT PERCUTANEOUS LAAC APPEARED TO BE A SAFE AND POTENTIALLY EFFECTIVE STRATEGY FOR PREVENTING ISCHEMIC STROKE IN HHT PATIENTS WITH ATRIAL FIBRILLATION (AF). [THE PRIMARY AND CORRESPONDING AUTHOR WAS ANTONI RIERA-MESTRE, INTERNAL MEDICINE DEPARTMENT, HOSPITAL UNIVERSITARI DE BELLVITGE, C/ FEIXA LLARGA S/N, L¿HOSPITALET DE LLOBREGAT, BARCELONA 08907, SPAIN, WITH CORRESPONDING E-MAIL: [email protected].] THIS STUDY INCLUDED ALL PATIENTS WITH AF AND A DEFINITE HHT DIAGNOSIS FROM 01 SEPTEMBER 2011 TO 31 DECEMBER 2024. A TOTAL OF 23 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 73.9% (17) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 72.52 YEARS. THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED ARTERIAL HYPERTENSION, DIABETES MELLITUS, DYSLIPIDEMIA, HEART FAILURE DISEASE, LUNG DISEASE, CANCER HISTORY, ATRIAL FIBRILLATION, AND PRIOR STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295546 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL UNK AMPLATZER AMULET

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability| D| R