BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER AMULET

    MDR report key: 19537581 · Received June 14, 2024

    Report

    Report Number
    2135147-2024-02818
    Event Type
    Death
    Date Received
    June 14, 2024
    Date of Event
    May 16, 2024
    Report Date
    June 14, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2 - DATE OF DEATH IS ESTIMATED. D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED SUMMARIZED PATIENT OUTCOMES OF AN AMPLATZER AMULET PROCEDURE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING SMOKING, PRIOR MAJOR BLEEDING, PAROXYSMAL ATRIAL FIBRILLATION, CAROTID DISEASE, MEDICATION ADHERENCE, HEMORRHAGIC TRANSFORMATION, THROMBOLYSIS, PRIOR ISCHEMIC STROKE, TRANSIENT ISCHEMIC ATTACK, AND HEMORRHAGIC STROKE. SOME OF THE COMPLICATIONS REPORTED WERE STROKE AND 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.

    Description of Event or Problem · 0

    THE ARTICLE, "ISCHEMIC STROKE SEVERITY AND MORTALITY AFTER LEFT ATRIAL APPENDAGE CLOSURE VS NON-WARFARIN ORAL ANTICOAGULANTS IN PATIENTS WITH PRIOR STROKE", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, MULTICENTER STUDY TO ISCHEMIC STROKE (IS) SEVERITY IN PATIENTS WITH ATRIAL FIBRILLATION (AF) AND PRIOR STROKE RECEIVING LEFT ATRIAL APPENDAGE CLOSURE (LAAC) VS NON-VITAMIN K ORAL ANTAGONISTS (NOAC). DEVICES INCLUDED IN THE STUDY WERE WATCHMAN, WATCHMAN FLX, AMPLATZER CARDIAC PLUG, AND AMULET. THE ARTICLE CONCLUDED THIS ANALYSIS DEMONSTRATED THAT IN AF PATIENTS WITH PRIOR STROKE, RECURRENT IS IS LESS OFTEN DISABLING OR FATAL WITH A SECONDARY STROKE PROPHYLAXIS STRATEGY OF LAAC THAN WITH NOAC. THE MECHANISM UNDERLYING REDUCED STROKE SEVERITY IN THE LAAC COHORT IS UNCLEAR. [THE PRIMARY AND CORRESPONDING AUTHOR WAS VIVEK REDDY, HELMSLEY ELECTROPHYSIOLOGY CENTER, MOUNT SINAI FUSTER HEART HOSPITAL, ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI, GUGGENHEIM PAVILLON, SUITE 280, 1190 FIFTH AVE, NEW YORK, NY 10029, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS NOT CONFIRMED. A TOTAL OF 447 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH IT WAS NOT CONFIRMED HOW MANY RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 74.3 YEARS FOR PATIENTS IN THE LEFT ATRIAL APPENDAGE CLOSURE (LAAC) GROUP AND 72.5 YEARS FOR PATIENTS IN THE NON-VITAMIN K ORAL ANTAGONISTS (NOAC) GROUP. NO INFORMATION WAS PROVIDED REGARDING MAJORITY GENDER. COMORBIDITIES INCLUDED SMOKING, PRIOR MAJOR BLEEDING, PAROXYSMAL ATRIAL FIBRILLATION, CAROTID DISEASE, MEDICATION ADHERENCE, HEMORRHAGIC TRANSFORMATION, THROMBOLYSIS, PRIOR ISCHEMIC STROKE, TRANSIENT ISCHEMIC ATTACK, AND HEMORRHAGIC STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394071 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death