BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER AMULET

    MDR report key: 22829064 · Received August 18, 2025

    Report

    Report Number
    2135147-2025-04604
    Event Type
    Death
    Date Received
    August 18, 2025
    Date of Event
    August 14, 2021
    Report Date
    September 22, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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, CONGESTIVE HEART FAILURE, HYPERTENSION, VASCULAR DISEASE, PRIOR BLEEDING, INTRACRANIAL BLEEDING, CORONARY ARTERY DISEASE, PRIOR LEFT ATRIAL APPENDAGE OCCLUSION INTERVENTION, AND PRIOR CARDIAC STRUCTURAL INTERVENTION. COMPLICATIONS REPORTED INCLUDED DEATH, SURGICAL INTERVENTION, UNEXPECTED MEDICAL INTERVENTION (PERICARDIOCENTESIS), HOSPITALIZATION, STROKE, CARDIAC TAMPONADE, MYOCARDIAL INFARCTION, PERICARDIAL EFFUSION, TRANSIENT ISCHEMIC ATTACK, BLEEDING, DEVICE EMBOLIZATION, THROMBUS, RESIDUAL SHUNT; 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. B2: DATE OF DEATH IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: OUTCOMES FOR SINGLE ANTIPLATELET, DUAL ANTIPLATELET, OR ORAL ANTICOAGULATION AFTER AMULET: INSIGHTS FROM EMERGE LAA POST-APPROVAL STUDY.

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION B2: DATE OF DEATH WAS ESTIMATED D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: OUTCOMES FOR SINGLE ANTIPLATELET, DUAL ANTIPLATELET, OR ORAL ANTICOAGULATION AFTER AMULET: INSIGHTS FROM EMERGE LAA POST-APPROVAL STUDY.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THE ARTICLE, "OUTCOMES FOR SINGLE ANTIPLATELET, DUAL ANTIPLATELET, OR ORAL ANTICOAGULATION AFTER AMULET: INSIGHTS FROM EMERGE LAA POST-APPROVAL STUDY", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, MULTICENTER STUDY ON OUTCOMES FROM PATIENTS DISCHARGED ON DUAL ANTIPLATELET THERAPY (DAPT) VERSUS SINGLE ANTIPLATELET THERAPY (SAPT) OR ORAL ANTICOAGULATION (OAC) FOLLOWING AMULET IMPLANT IN THE EMERGE LAA POST -APPROVAL STUDY. DEVICES INCLUDED IN THE STUDY WERE SOLELY AMPLATZER AMULET. THE ARTICLE CONCLUDED THAT IN THE PRESENT COHORT OF PATIENTS TREATED WITH AMULET LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) THERE WERE HIGH RATES OF LAA COMPLETE CLOSURE, AND SAPT EMERGED AS A VIABLE ALTERNATIVE TO THE CURRENT DAPT REGIMEN POTENTIALLY REDUCING THE RISK OF BLEEDING COMPLICATIONS IN PATIENTS AT HIGH RISK WITHOUT COMPROMISING EFFECTIVENESS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS ATMAN SHAH, THE UNIVERSITY OF CHICAGO, GOLDBLATT PAVILION, 5841 S MARYLAND AVE, CHICAGO, IL 60637, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS 14 AUGUST 2021 TO 15 DECEMBER 2023. A TOTAL OF 11,445 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH ALL RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 77.0 YEARS AND THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED ATRIAL FIBRILLATION, PRIOR STROKE, DIABETES MELLITUS, CONGESTIVE HEART FAILURE, HYPERTENSION, VASCULAR DISEASE, PRIOR BLEEDING, INTRACRANIAL BLEEDING, CORONARY ARTERY DISEASE, PRIOR LEFT ATRIAL APPENDAGE OCCLUSION INTERVENTION, AND PRIOR CARDIAC STRUCTURAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680217 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL UNK AMPLATZER AMULET

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death