BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER AMULET

    MDR report key: 18841921 · Received March 5, 2024

    Report

    Report Number
    2135147-2024-01011
    Event Type
    Death
    Date Received
    March 5, 2024
    Date of Event
    February 5, 2023
    Report Date
    March 28, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THE ADDITIONAL PATIENT EFFECTS AND MALFUNCTIONS REPORTED IN THE ARTICLES ARE CAPTURED UNDER SEPARATE MEDWATCH REPORTS. B2 - DATE OF DEATH IS ESTIMATED. B3 - DATE OF EVENT IS ESTIMATED. D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF AMPLATZER AMULET WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING MITRAL VALVE DISEASE, HISTORY OF TRANSCATHETER EDGE-TO-EDGE PROCEDURE, HISTORY OF SURGICAL MITRAL VALVE REPAIR, ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, CARDIOMYOPATHY, CONGESTIVE HEART FAILURE, ANEMIA, DIABETES MELLITUS, CHRONIC KIDNEY DISEASE, VASCULAR DISEASE, PERIPHERAL ARTERY DISEASE, HISTORY OF STROKE, CHRONIC LIVER DISEASE, AND ALCOHOL USE. SOME OF THE COMPLICATIONS REPORTED WERE DEATH, SURGICAL INTERVENTION, UNEXPECTED MEDICAL INTERVENTION, HOSPITALIZATION, MYOCARDIAL INFARCTION, STROKE, BLEEDING, FISTULA/PSEUDOANEURYSM, PERICARDIAL EFFUSION, THROMBUS, TRANSIENT ISCHEMIC ATTACK, DEVICE EMBOLIZATION, AND 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.

    Description of Event or Problem · 0

    THE ARTICLE, "ASSOCIATION OF ATRIAL MYOPATHY IN MITRAL VALVE DISEASE ON SAFETY OUTCOMES IN LEFT ATRIAL APPENDAGE CLOSURE", WAS REVIEWED. THE ARTICLE PRESENTED A PROSPECTIVE, MULTI-CENTER STUDY TO IDENTIFY HOW ATRIAL MYOPATHY IN MITRAL VALVE DISEASE (MVD) INFLUENCES OUTCOMES IN LEFT ATRIAL APPENDAGE (LAA) OCCLUSION (LAAO). DEVICES INCLUDED IN THIS STUDY WERE WATCHMAN, AMPLATZER CARDIAC PLUG, AND AMPLATZER AMULET. THE ARTICLE CONCLUDED THAT PATIENTS WITH MVD PRESENT WITH ALTERED LA ANATOMY WITH INCREASED LA AND LAA DIAMETER. HOWEVER, PROCEDURAL SUCCESS AND SAFETY IN LAAO ARE NOT COMPROMISED. ONE-YEAR MORTALITY IS NUMERICALLY HIGHER IN PATIENTS WITH MVD BUT DRIVEN BY COMORBIDITIES. [THE PRIMARY AND CORRESPONDING AUTHOR WAS SHINWAN KANY, DIVISION OF CARDIOLOGY, UNIVERSITY HEART AND VASCULAR CENTER HAMBURG-EPPENDORF, MARTINISTRASSE 52, 20251 HAMBURG, GERMANY, WITH CORRESPONDING EMAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS NOT REPORTED. A TOTAL OF 528 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 287 (54.4%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 78.2 YEARS FOR THE MITRAL VALVE DISEASE (MVD) GROUP AND 75.9 YEARS FOR THE NO-MVD GROUP. THE AVERAGE GENDER WAS FEMALE FOR THE MVD GROUP, MALE FOR THE NO-MVD GROUP, AND MALE FOR OVERALL. THE AVERAGE WEIGHT WAS 68 KG FOR THE MVD GROUP AND 80 KG FOR THE NO-MVD GROUP. COMORBIDITIES INCLUDED MITRAL VALVE DISEASE, HISTORY OF TRANSCATHETER EDGE-TO-EDGE PROCEDURE, HISTORY OF SURGICAL MITRAL VALVE REPAIR, ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, CARDIOMYOPATHY, CONGESTIVE HEART FAILURE, ANEMIA, DIABETES MELLITUS, CHRONIC KIDNEY DISEASE, VASCULAR DISEASE, PERIPHERAL ARTERY DISEASE, HISTORY OF STROKE, CHRONIC LIVER DISEASE, ALCOHOL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144257 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death