BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER AMULET

    MDR report key: 24235769 · Received February 2, 2026

    Report

    Report Number
    2135147-2026-00574
    Event Type
    Death
    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

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF AMPLATZER AMULET WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING ARTERIAL HYPERTENSION, DIABETES MELLITUS, DYSLIPIDEMIA, HEART FAILURE DISEASE, LUNG DISEASE, CANCER HISTORY, ATRIAL FIBRILLATION, AND PRIOR STROKE. COMPLICATIONS REPORTED INCLUDED PERICARDIAL EFFUSION, STROKE, BLEEDING, UNEXPECTED MEDICAL INTERVENTION (MEDICATION REQUIRED), DEATH; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT 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 ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. LITERATURE ATTACHMENT: LEFT ATRIAL APPENDAGE CLOSURE IN PATIENTS WITH HEREDITARY HEMORRHAGIC TELANGIECTASIA AND ATRIAL FIBRILLATION: A PROSPECTIVE STUDY AND SYSTEMATIC REVIEW. B3: EVENT DATE WAS ESTIMATED. B2: DEATH DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    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 (B)(6).] THIS STUDY INCLUDED ALL PATIENTS WITH AF AND A DEFINITE HHT DIAGNOSIS FROM (B)(6) 2011 TO (B)(6) 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
    293152 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL UNK AMPLATZER AMULET

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death