BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX?

    MDR report key: 22043875 · Received May 19, 2025

    Report

    Report Number
    2124215-2025-31869
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    October 3, 2022
    Report Date
    June 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860495
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    D4 MODEL NUMBER, LOT NUMBER, CATALOG NUMBER, EXPIRATION DATE: UPDATED WITH ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    REPORTED VIA CLINICAL STUDY IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED FOR A WATCHMAN CLINICAL STUDY. THE PATIENT WAS CROSSOVER TO DEVICE GROUP AND UNDERWENT SUCCESSFUL PLACEMENT OF A COMMERCIALLY AVAILABLE 24 MM WATCHMAN FLX LAA CLOSURE DEVICE WITH A COMPLETE LAA SEAL. THE PATIENT WAS DISCHARGED ON 5-OCT-2021 ON ASPIRIN (81 MG/DAY) AND CLOPIDOGREL (75 MG/DAY). ON 03-OCT-2022, 363 DAYS POST INDEX PROCEDURE, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED WHICH REVEALED A THROMBUS ON THE CLOSURE DEVICE. AT THE TIME OF EVENT, THE PATIENT WAS ON ASPIRIN (81 MG/DAY). IN RESPONSE TO THE EVENT, APIXABAN (10 MG/DAY) WAS STARTED. ON 03-NOV-2022, TEE IMAGING WAS PERFORMED WHICH REVEALED A COMPLETE LAA SEAL WITH ESTIMATED LEFT VENTRICULAR EJECTION FRACTION (LVEF) OF 50% AND A LAMINAR, NON-MOBILE THROMBUS ON THE ATRIAL FACING SURFACE OF THE CLOSURE DEVICE. ON 17-JAN-2023, THE EVENT WAS CONSIDERED TO BE RESOLVED.

    Description of Event or Problem · 0

    REPORTED VIA CLINICAL STUDY: IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED FOR A WATCHMAN CLINICAL STUDY. THE PATIENT WAS CROSSOVER TO DEVICE GROUP AND UNDERWENT SUCCESSFUL PLACEMENT OF A COMMERCIALLY AVAILABLE 24 MM WATCHMAN FLX LAA CLOSURE DEVICE WITH A COMPLETE LAA SEAL. THE PATIENT WAS DISCHARGED ON (B)(6) 2021 ON ASPIRIN (81 MG/DAY) AND CLOPIDOGREL (75 MG/DAY). ON (B)(6) 2022, 363 DAYS POST INDEX PROCEDURE, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED WHICH REVEALED A THROMBUS ON THE CLOSURE DEVICE. AT THE TIME OF EVENT, THE PATIENT WAS ON ASPIRIN (81 MG/DAY). IN RESPONSE TO THE EVENT, APIXABAN (10 MG/DAY) WAS STARTED. ON (B)(6) 2022, TEE IMAGING WAS PERFORMED WHICH REVEALED A COMPLETE LAA SEAL WITH ESTIMATED LEFT VENTRICULAR EJECTION FRACTION (LVEF) OF 50% AND A LAMINAR, NON-MOBILE THROMBUS ON THE ATRIAL FACING SURFACE OF THE CLOSURE DEVICE. ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142956 WATCHMAN FLX? SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU50240 0027827769 08714729860495

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other