BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 18597706 · Received January 29, 2024

    Report

    Report Number
    2124215-2024-02177
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    November 1, 2014
    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 01NOV2014 AS THE DATE RANGE IS FROM NOVEMBER 2014 TO APRIL 2022. 4 WATCHMAN FLX AND 2 WATCHMAN 2.5 COMPLAINT EVENTS WERE OPENED FOR BELGIUM BASED ON REVIEW OF THE ATTACHED LITERATURE ARTICLE PER THE LOCATION OF THE LEAD AUTHOR AS THE DETAILS OF WHERE EACH EVENT OCCURRED WERE NOT SPECIFIED; IF ADDITIONAL INFORMATION IS RECEIVED A LATER DATE, IT WILL BE REVIEWED AT THAT TIME. 8 WATCHMAN FLX AND 1 WATCHMAN 2.5 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 THROMBOSIS OCCURRED. LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PROCEDURES WERE PERFORMED WITH MINIATURIZED TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PROBES FOR 546 PATIENTS BETWEEN (B)(6) 2014 AND (B)(6) 2022. OF THE IMPLANTED DEVICES FROM THE STUDY, 301 WERE ATTRIBUTED TO THE WATCHMAN PRODUCT. THE PRESENCE OF DEVICE RELATED THROMBUS WAS DETECTED IN 21 PATIENTS IN THE STUDY. 13 CASES WERE DETECTED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), 4 CASES WERE DETECTED BY COMPUTED TOMOGRAPHY (CT), AND 4 CASES WERE DETECTED BY BOTH TEE AND CT. DEVICE RELATED THROMBUS OCCURRED ON A WATCHMAN 2.5 CLOSURE DEVICE IN 3 CASES AND A WATCHMAN FLX CLOSURE DEVICE IN 12 CASES. THE OTHER CASES WERE NON-BOSTON SCIENTIFIC PRODUCTS. THE MEDIAN DAYS TO IMAGING FOLLOW UP WAS 64 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825752 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other