BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 18597579 · Received January 29, 2024

    Report

    Report Number
    2124215-2024-02222
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    October 1, 2015
    Report Date
    January 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT - ESTIMATED AS 01OCT2015 AS THE DATE RANGE IS FROM NOVEMBER 2014 TO APRIL 2022, BUT THE WATCHMAN FLX DEVICE WAS NOT APPROVED IN THE EU UNTIL OCTOBER 2015. THIS LITERATURE IDENTIFIED PERIPROCEDURAL COMPLICATIONS RELATING TO WATCHMAN AND NON-BSC PRODUCTS INCLUDING DEATH. THE 2 DEATHS WERE IDENTIFIED AS DUPLICATES TO EXISTING COMPLAINTS. LITERATURE CITATION: AMINIAN A, LEDUC N, FREIXA X, SWAANS MJ, BEN YEDDER M, MAARSE M, SANCHIS L, CEPAS-GUILLEN P, CRUZ-GONZALEZ I, BLANCO-FERNANDEZ F, ESCHALIER R, BOERSMA LVA. LEFT ATRIAL APPENDAGE OCCLUSION UNDER MINIATURIZED TRANSESOPHAGEAL ECHOCARDIOGRAPHIC GUIDANCE AND CONSCIOUS SEDATION: MULTICENTER EUROPEAN EXPERIENCE. JACC CARDIOVASC INTERV. 2023 AUG 14;16(15):1889-1898. DOI: 10.1016/J.JCIN.2023.06.007. PMID: 37587597.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT CARDIAC TAMPONADE (MAJOR BLEEDING) AND TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PROCEDURES WERE PERFORMED WITH MINIATURIZED TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PROBES FOR 546 PATIENTS BETWEEN NOVEMBER 2014 AND APRIL 2022. OF THE IMPLANTED DEVICES FROM THE STUDY, 301 WERE ATTRIBUTED TO THE WATCHMAN PRODUCT. A TOTAL OF 16 PERIPROCEDURAL CLINICAL OUTCOMES OCCURRED IN 15 PATIENTS. THE PERIPROCEDURAL COMPLICATIONS INCLUDED CARDIAC TAMPONADE IN 9 PATIENTS, MAJOR BLEEDING EVENTS IN 4 PATIENTS, TRANSIENT ISCHEMIC ATTACK (TIA) IN 1 PATIENT, AND DEATH IN 2 PATIENTS. ONE PATIENT DEVELOPED SEVERE PROCEDURAL TAMPONADE DUE TO ATRIAL PERFORATION REQUIRING LAA SURGICAL REPAIR AND LIGATION AND ULTIMATELY DIED FROM POSTOPERATIVE CIRCULATORY SHOCK AND MULTIORGAN FAILURE. THE OTHER PATIENT DIED FROM TYPE 2 ACUTE CORONARY SYNDROME IN THE SETTING OF RECURRENT AND SEVERE GASTROINTESTINAL BLEEDING EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824749 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 Unknown Other