BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER AMULET

    MDR report key: 17199398 · Received June 26, 2023

    Report

    Report Number
    2135147-2023-02747
    Event Type
    Malfunction
    Date Received
    June 26, 2023
    Date of Event
    June 9, 2023
    Report Date
    June 26, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    PMA / PMN Number
    P200049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ADDITIONAL PATIENT EFFECTS REPORTED IN THE ARTICLE ARE CAPTURED UNDER A SEPARATE MEDWATCH REPORT. 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 LEFT ATRIAL APPENDAGE CLOSURE WAS REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING ARTERIAL HYPERTENSION, DIABETES MELLITUS, PRIOR STROKE/TIA AND PRIOR DIAGNOSIS OF DEVICE-RELATED THROMBUS.. SOME OF THE COMPLICATIONS REPORTED WERE STROKE, DEVICE-RELATED THROMBUS, ATRIAL FIBRILLATION, 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, "SYMPTOMATIC VS. NON-SYMPTOMATIC DEVICE-RELATED THROMBUS AFTER LAAC: A SUB-ANALYSIS FROM THE MULTICENTER EUROC-DRT REGISTRY", WAS REVIEWED. THE ARTICLE IS A RETROSPECTIVE EXPERIENCE AIMED TO IDENTIFY PREDISPOSING FACTORS FOR STROKE/SYSTEMIC EMBOLISM (SE) IN DEVICE-RELATED THROMBUS (DRT) PATIENTS AFTER LEFT ATRIAL APPENDAGE CLOSURE (LAAC). DEVICES MENTIONED IN THE STUDY INCLUDED AMPLATZER AMULET, LAMBRE, ULTRASEAL, WATCHMAN, WAVECREST, AND OCCLUTECH. THE ARTICLE CONCLUDED STROKE/SE ARE DOCUMENTED IN 14.2% AND OCCUR BOTH IN CLOSE TEMPORAL RELATION TO THE DRT FINDING AND CHRONOLOGICALLY INDEPENDENTLY THEREFROM. IDENTIFICATION OF RISK FACTORS REMAINS CUMBERSOME, PUTTING ALL DRT PATIENTS AT SUBSTANTIAL RISK FOR STROKE/SE. FURTHER STUDIES ARE NECESSARY TO MINIMIZE THE RISK OF DRT AND ISCHEMIC EVENTS. [THE PRIMARY AND CORRESPONDING AUTHOR IS ALEXANDER SEDAGHAT, DEPARTMENT OF CARDIOLOGY, UNIVERSITY HOSPITAL BONN, VENUSBERG-CAMPUS 1, 53127 BONN, GERMANY, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY IS UNKNOWN. A TOTAL OF 176 PATIENTS WERE INVOLVED IN THIS STUDY WITH THE AVERAGE AGE OF 76-YEAR-OLD AND AVERAGE GENDER WAS MALE. COMORBIDITIES INCLUDED ARTERIAL HYPERTENSION, DIABETES MELLITUS, PRIOR STROKE/TIA, PRIOR DIAGNOSIS OF DEVICE-RELATED THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834275 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown