BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 14015220 · Received April 5, 2022

    Report

    Report Number
    2134265-2022-03387
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    December 22, 2021
    Report Date
    April 5, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS SUCCESSFULLY PERFORMED USING A 35MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). ON (B)(6) 2021 AT A FOLLOW-UP EXAMINATION, THE PATIENT PRESENT WITH DYSPNEA, A COUGH, HYPOTENSION, AND ATRIAL FIBRILLATION WITH A RAPID VENTRICULAR RESPONSE. CARDIOVERSION WAS PERFORMED TO REGAIN A NORMAL HEART RHYTHM. ELIQUIS WAS PRESCRIBED FOR THE FOLLOWING FOUR WEEKS AND 81MG OF ASPIRIN WAS CONTINUED. ON (B)(6) 2021, 54 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENT AT THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH AND ATRIAL FIBRILLATION. RADIOGRAPHS REVEALED AN ENLARGED CARDIAC SILHOUETTE AND THE PATIENT WAS DISCHARGED. ON (B)(6) 2021 THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT WITH DYSPNEA, SWELLING OF THE FEET AND LEGS, WEIGHT GAIN OF 25 POUNDS, AND ATRIAL FIBRILLATION. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION WHICH WAS TREATED WITH A PERICARDIOCENTESIS. 950ML OF BLOOD WAS DRAINED. THE PATIENT HAS IMPROVED SINCE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812703 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0027209374 08714729860525

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention