BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER AMULET

    MDR report key: 24621178 · Received March 17, 2026

    Report

    Report Number
    2135147-2026-01713
    Event Type
    Death
    Date Received
    March 17, 2026
    Date of Event
    February 1, 2019
    Report Date
    March 17, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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 HYPERTENSION, DYSLIPIDEMIA, CONGESTIVE HEART FAILURE, VASCULAR DISEASE, DIABETES, CHRONIC KIDNEY DISEASE, AND PREVIOUS ISCHEMIC STROKE, TRANSIENT ISCHEMIC ATTACK, AND MYOCARDIAL INFARCTION. COMPLICATIONS REPORTED INCLUDED DEVICE MIGRATION, STROKE, PERICARDIAL EFFUSION, TRANSIENT ISCHEMIC ATTACK, UNEXPECTED MEDICAL INTERVENTION (PERICARDIOCENTESIS), 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. LITERATURE ATTACHMENT: REAL-WORLD OUTCOMES OF LEFT ATRIAL APPENDAGE OCCLUSION WITH THE AMPLATZER¿ AMULET¿: A MULTICENTRE OBSERVATIONAL REGISTRY FROM SOUTHEAST ASIA B2: DEATH DATE WAS ESTIMATED B3: EVENT 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, "REAL-WORLD OUTCOMES OF LEFT ATRIAL APPENDAGE OCCLUSION WITH THE AMPLATZER¿ AMULET¿: A MULTICENTRE OBSERVATIONAL REGISTRY FROM SOUTHEAST ASIA", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE THE PROCEDURAL CHARACTERISTICS, SAFETY PROFILES AND 1-YEAR CLINICAL OUTCOMES OF THE AMULET DEVICE. THE DEVICE INCLUDED IN THIS STUDY WAS THE AMPLATZER AMULET. THE ARTICLE CONCLUDED THAT PATIENTS FROM SOUTHEAST ASIA (SEA) HAD MULTIPLE INDICATIONS FOR LEFT ATRIAL APPENDAGE OCCLUSION (LAAO). THE AMULET DEVICE DEMONSTRATED HIGH PROCEDURAL SUCCESS, LOW COMPLICATION RATES AND ASSOCIATED WITH LOW RATE OF ATRIAL FIBRILLATION-RELATED THROMBOEMBOLIC EVENT WHILE USING SINGLE ANTIPLATELET THERAPY IN MOST OF THE PATIENTS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS KENG TAT KOH, DEPARTMENT OF CARDIOLOGY, SARAWAK HEART CENTRE, 3RD ROUNDABOUT, KUCHING - SAMARAHAN EXPRESSWAY, 94300 KOTA SAMARAHAN, SARAWAK, MALAYSIA, WITH CORRESPONDING E-MAIL: [email protected].] THIS STUDY INCLUDED PATIENTS UNDERGOING LAAO FROM 01 FEBRUARY 2019 TO 31 JANUARY 2024. A TOTAL OF 104 PATIENTS WERE INCLUDED IN THE STUDY, ALL OF WHICH RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 67.2 YEARS. THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED HYPERTENSION, DYSLIPIDEMIA, CONGESTIVE HEART FAILURE, VASCULAR DISEASE, DIABETES, CHRONIC KIDNEY DISEASE, AND PREVIOUS ISCHEMIC STROKE, TRANSIENT ISCHEMIC ATTACK, AND MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682335 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL UNK AMPLATZER AMULET

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death