BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER AMULET

    MDR report key: 23633095 · Received November 24, 2025

    Report

    Report Number
    2135147-2025-06881
    Event Type
    Death
    Date Received
    November 24, 2025
    Date of Event
    August 14, 2021
    Report Date
    December 12, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 ATRIAL FIBRILLATION, PRIOR STROKE, DIABETES MELLITUS, HEART FAILURE, HYPERTENSION, VASCULAR DISEASE, PRIOR BLEEDING, LEFT ATRIAL APPENDAGE OCCLUSION INTERVENTION, AND PRIOR CARDIAC STRUCTURAL INTERVENTION. COMPLICATIONS REPORTED INCLUDED DEATH, PERICARDIAL EFFUSION, STROKE, MYOCARDIAL INFARCTION, CARDIAC ARREST, THROMBUS, BLEEDING, SYSTEMIC EMBOLISM, PSEUDOANEURYSM, TRANSIENT ISCHEMIC ATTACK, SURGICAL INTERVENTION (N/A), SURGICAL INTERVENTION (SURGICAL EXPLANT), UNEXPECTED MEDICAL INTERVENTION (N/A), UNEXPECTED MEDICAL INTERVENTION (PERICARDIOCENTESIS), HOSPITALIZATION/PROLONGED-HOSPITALIZATION, DEVICE EMBOLIZATION, PATIENT DEVICE INTERACTION PROBLEM (THROMBUS); 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.

    Additional Manufacturer Narrative · 0

    LITERATURE ATTACHMENT: IMPACT OF PRE- AND POST-DILATATION ON LONG-TERM OUTCOMES AFTER SELF-EXPANDING AND BALLOON-EXPANDABLE TAVI. 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, "COMPARATIVE OUTCOMES OF INTRACARDIAC VS TRANSESOPHAGEAL ECHOCARDIOGRAPHIC GUIDANCE FOR LEFT ATRIAL APPENDAGE OCCLUSION", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE OUTCOMES FROM PROCEDURES GUIDED BY INTRACARDIAC ECHOCARDIOGRAM (ICE) VERSUS TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) VERSUS BOTH FOR GUIDANCE OF AMPLATZER AMULET IMPLANTATION IN THE EMERGE LEFT ATRIAL APPENDAGE (LAA) POST-APPROVAL STUDY. THE DEVICE INCLUDED IN THE STUDY WAS THE AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER. THE ARTICLE CONCLUDED THAT BOTH ICE AND TEE ARE SAFE AND EFFECTIVE FOR AMULET LAAO GUIDANCE, WITH HIGH ACUTE SUCCESS AND CLOSURE RATES. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MOHAMAD ALKHOULI, MAYO CLINIC SCHOOL OF MEDICINE, 200 FIRST STREET SW, ROCHESTER, MINNESOTA 55905, USA. WITH CORRESPONDING E-MAIL: [email protected].] THIS STUDY INCLUDED PATIENTS ENROLLED IN THE EMERGE LAA POST-APPROVAL STUDY FROM 14 AUGUST 2021 TO 15 DECEMBER 2023. A TOTAL OF 11,848 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH ALL RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE OF THE INTRACARDIAC ECHOCARDIOGRAM (ICE) GROUP WAS 76.5 YEARS. THE AVERAGE AGE OF THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) GROUP WAS 77.1 YEARS. THE AVERAGE AGE OF THE ICE AND TEE GROUP WAS 77.2 YEARS. THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED ATRIAL FIBRILLATION, PRIOR STROKE, DIABETES MELLITUS, HEART FAILURE, HYPERTENSION, VASCULAR DISEASE, PRIOR BLEEDING, LEFT ATRIAL APPENDAGE OCCLUSION INTERVENTION, AND PRIOR CARDIAC STRUCTURAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627929 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL UNK AMPLATZER AMULET

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death