BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 17695073 · Received September 6, 2023

    Report

    Report Number
    2135147-2023-03878
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    September 9, 2022
    Report Date
    October 30, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF THROMBUS WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. INFORMATION FROM THE FIELD INDICATED THAT A DEVICE-RELATED THROMBUS (DRT) WAS ON THE DISC'S BACKSIDE, AND IT WAS LESS THAN 5MM IN SIZE. THERE WAS NO INFILTRATION OR PLEURAL ACCUMULATION. THE UNCHANGED DRT WAS STILL SEEN ON THE DISC. PATIENT STATES THAT THEY ARE UNABLE TO TAKE ANTICOAGULATION DUE TO HISTORY OF HEMATURIA. LATER ON, A SECOND CT SCAN WAS PERFORMED, AND THE SAME RESULT WAS OBTAINED. THE PATIENT ONLY TAKES 75MG ASPIRIN DAILY. THE PATIENT STATUS WAS STABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THROMBUS IS A POSSIBLE OUTCOME OF THE PROCEDURE PER THE AMPLATZER AMULET INSTRUCTIONS FOR USE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    USER FACILITY MEDWATCH REPORT # MW5120015 RECEIVED THAT STATES "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. IT WAS REPORTED THAT ON (B)(6) 2022, AN UNKNOWN SIZE AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SUCCESSFULLY IMPLANTED DURING A LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) FOR ATRIAL FIBRILLATION (AF). AFTER 101 DAYS, POST PROCEDURE A DEVICE RELATED THROMBUS (DRT) WAS FOUND. THERE WAS NO INFORMATION ABOUT THE THROMBUS BEFORE THE LAAO. ON (B)(6) 2023, SECOND COMPUTED TOMOGRAPHY (CT) SCANNING WAS PERFORMED, SAME RESULT WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995708 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other