BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19776830 · Received July 18, 2024

    Report

    Report Number
    2124215-2024-44333
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    July 15, 2024
    Report Date
    July 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: INFORMATION ADDED. B7: INFORMATION ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 35MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS PLACED ON ELIQUIS AND ASPIRIN ORAL ANTICOAGULANT (OAC) MEDICATION REGIMEN. AT THE 45 DAY ROUTINE FOLLOW UP, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A DEVICE RELATED THROMBUS (DRT) ON THE THREADED INSERT OF THE CLOSURE DEVICE. THE PHYSICIANS PLACED THE PATIENT BACK ON ELIQUIS MEDICATION AND WILL DO A FOLLOW UP TEE IN THREE MONTHS IN RESPONSE TO THE DRT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 35MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS PLACED ON ELIQUIS AND ASPIRIN ORAL ANTICOAGULANT (OAC) MEDICATION REGIMEN. AT THE 45-DAY ROUTINE FOLLOW UP, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A DEVICE RELATED THROMBUS (DRT) ON THE THREADED INSERT OF THE CLOSURE DEVICE. THE PHYSICIANS PLACED THE PATIENT BACK ON ELIQUIS MEDICATION AND WILL DO A FOLLOW UP TEE IN THREE MONTHS IN RESPONSE TO THE DRT. IT WAS FURTHER REPORTED THAT THE OAC REGIMEN CONSISTED OF PLAVIX AND ASPIRIN POST INDEX PROCEDURE, AND THE PATIENT REPORTED BEING COMPLIANT. THE DRT WAS LAMINAR IN NATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1962089 WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION WS6035 0033704671

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Required Intervention