BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 16014828 · Received December 20, 2022

    Report

    Report Number
    2124215-2022-53769
    Event Type
    Injury
    Date Received
    December 20, 2022
    Date of Event
    December 16, 2022
    Report Date
    January 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT - AWARE DATE OF (B)(6) 2022 USED AS EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED. AT THE 45-DAY FOLLOW-UP TRANSESOPHAGEAL ECHO (TEE), A DEVICE RELATED THROMBUS WAS NOTED. THE PATIENT HAD STOPPED TAKING ALL MEDICATIONS INCLUDING ORAL ANTICOAGULATION PRIOR TO FOLLOW-UP. THE PATIENT WAS EDUCATED ON THE IMPORTANCE OF ORAL ANTICOAGULATION (OAC) REGIMEN. THE PATIENT WAS PLACED ON AN OAC REGIMEN AND IMAGING WILL ASSESS THE DEVICE RELATED THROMBUS IN THREE MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED. AT THE 45-DAY FOLLOW-UP TRANSESOPHAGEAL ECHO (TEE), A DEVICE RELATED THROMBUS WAS NOTED. THE PATIENT HAD STOPPED TAKING ALL MEDICATIONS INCLUDING ORAL ANTICOAGULATION PRIOR TO FOLLOW-UP. THE PATIENT WAS EDUCATED ON THE IMPORTANCE OF ORAL ANTICOAGULATION (OAC) REGIMEN. THE PATIENT WAS PLACED ON AN OAC REGIMEN AND IMAGING WILL ASSESS THE DEVICE RELATED THROMBUS IN THREE MONTHS. IT WAS FURTHER REPORTED THAT THE THROMBUS COVERED A LARGE PORTION OF THE FACE OF THE DEVICE. THE THROMBUS LOOKED TO BE LAMINAR, NON-MOBILE AND DID NOT APPEAR TO BE BIASED TOWARD THE LIMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2908480 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other