BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19074641 · Received April 9, 2024

    Report

    Report Number
    2124215-2024-19891
    Event Type
    Death
    Date Received
    April 9, 2024
    Date of Event
    October 3, 2023
    Report Date
    April 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED AS 10/03/2023 AS THE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS 03 OCTOBER 2023. LITERATURE CITATION: RANA MA, YOON S, DALLAN LAP, ET AL. (2024) MIDTERM FOLLOW-UP AFTER COMPUTED TOMOGRAPHY ANGIOGRAPHY PLANNED LEFT ATRIAL APPENDAGE CLOSURE. CATHETER CARDIOVASC INTERV. 103(1):129-136. DOI:10.1002/CCD.30843.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT PATIENT DEATHS OCCURRED. THE FOLLOWING EVENT WAS OBTAINED VIA A RETROSPECTIVE ARTICLE FOLLOWING 231 PATIENTS WHO HAD THE WATCHMAN GEN 2.5 OR FLX IMPLANTED IN THE LEFT ATRIAL APPENDAGE (LAA) FROM JANUARY 26, 2017, TO NOVEMBER 23, 2021. ALL PATIENTS HAD CARDIAC COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) USED FOR THE PRE-PROCEDURAL PLANNING. ALL PROCEDURES WERE PERFORMED WITH INTRACARDIAC ECHOCARDIOGRAPHY. THE MEAN FOLLOW UP WAS 608.94 DAYS. OF THE 231 PATIENTS, THERE WERE 51 DEATHS FROM ALL CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288811 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death