BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19703085 · Received July 9, 2024

    Report

    Report Number
    2124215-2024-41772
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    May 16, 2024
    Report Date
    July 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED AS 05/16/2024 AS THE POSTER DATE FOR THE ARTICLE PRESENTATION IS NOTED AS 2024-05-16 TO 2024-05-19. CITATION: GARAPATI, SS., FUENTES ROJAS, SC., ASEMOTA, IR., NA, J., & PATEL, A. (2024). A CASE OF INTRA PROCEDURAL DEVICE RELATED THROMBUS DURING PERCUTANEOUS LEFT ATRIAL APPENDAGE OCCLUSION MANAGED BY MECHANICAL ASPIRATION. HEART RHYTHM. 2024; 21 (5 SUPPL): S314. ABSTRACT PO-02-022 HEART RHYTHM 2024 UNITED STATES, BOSTON 2024-05-16 TO 2024-05-19.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT THROMBOSIS OCCURRED. LEFT ATRIAL APPENDAGE THROMBUS WAS RULED OUT BY A PRE-OP TRANSESOPHAGEAL ECHOCARDIOGRAM. A 27 MM WATCHMAN FLX DEVICE WAS SUCCESSFULLY DEPLOYED GUIDED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IN THE LEFT ATRIUM AND CARTOSOUND TO ANATOMICALLY TRACK THE DEVICE. THE DEVICE WAS SECURELY SEATED WITHOUT EVIDENCE OF PERI-DEVICE LEAK. THE ACTIVATED CLOTTING TIME (ACT) WAS GREATER THAN 300 SECONDS. HOWEVER, ON FINAL ICE SURVEILLANCE, A LARGE THROMBUS (14 MM X 15 MM) WAS NOTED ON THE WATCHMAN DEVICE. ADMINISTRATION OF HEPARIN AND ASPIRATION THROUGH THE WATCHMAN SHEATH WAS UNSUCCESSFUL. THE THROMBUS WAS THEN THOROUGHLY IMAGED WITH ICE AND DRAWN ONTO THE 3-DIMENSIONAL MAP WITH CARTOSOUND. A SECOND TRANSSEPTAL WAS THEN PERFORMED AND A NON-BOSTON SCIENTIFIC (BSC) CATHETER WAS PLACED VIA A NON-BSC SHEATH INTO THE LEFT ATRIUM. THE CATHETER WAS TRACKED ON THE MAPPING SYSTEM TO GUIDE THE SHEATH TOWARD THE ICE CONTOUR OF THE THROMBUS. A NON-BSC EXPORT CATHETER WAS THEN INTRODUCED VIA THE SHEATH THROUGH WHICH THE THROMBUS WAS SUCCESSFULLY ASPIRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250142 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 08714729860501

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention