BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER

    MDR report key: 17390852 · Received July 24, 2023

    Report

    Report Number
    MW5120015
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    September 9, 2022
    Report Date
    July 21, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    "CANNOT TAKE OAK." DOCUMENTED YEARS BACK. ATRIAL FIBRILLATION. VASC SCORE 2 BEFORE LAAO (B)(6) 2022 IN (B)(6). DRT DETECTED POST PROCEDURE 101 DAYS WITH THE ABBOTT AMPLATZER AMULET DEVICE. NOW AT HIGH RISK FOR ADVERSE EVENTS. NO INFORMATION WHATSOEVER OF DRT BEFORE LAAO, THOUGH DATA ON THROMBUS CHARACTERISTICS, TREATMENT STRATEGIES, AND CLINICAL OUTCOMES FROM THE EUROC-DRT-REGISTRY WERE PUBLISHED ONLY A YEAR BEFORE PROCEDURE. OPERATOR PART OF PUBLICATION. (REF CIRC CARDIOVASC INTERV.(CIRCULATION CARDIOVASCULAR INTERVENTIONS) 2021;14:E10195). SECOND CT SCANNING PERFORMED 23-03-2023 +195 DAYS. SAME RESULT. NOW ON 75 MG ASA. SLIGHT SPOTS NOW AND THEN. DO NOT AGREE ON HOSPITAL RISK ASSESSMENT. FROM HOSPITAL CASE CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635038 AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Life Threatening