BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19287982 · Received May 10, 2024

    Report

    Report Number
    2124215-2024-27438
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    April 11, 2024
    Report Date
    May 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE CORRECTED. B5: INFORMATION ADDED. B6: INFORMATION ADDED. D6A: DATE ADDED.

    Additional Manufacturer Narrative · 0

    B3: BOSTON SCIENTIFIC AWARE DATE USED FOR EVENT DATE, AS EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED, AND A WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS PLACED ON AN ORAL ANTICOAGULANT (OAC) MEDICATION REGIMEN. THE PATIENT WAS DISCHARGED. AT THE 45-DAY ROUTINE FOLLOW UP, IMAGING REVEALED A POTENTIAL DEVICE RELATED THROMBUS (DRT). THE PHYSICIANS RECOMMENDED THE PATIENT CONTINUE ON OAC. NO FURTHER INTERVENTIONS WERE REPORTED. IT WAS FURTHER CLARIFIED THAT THE IMPLANTED DEVICE WAS A 31MM WATCHMAN FLX CLOSURE DEVICE, AND THE DRT WAS FOUND AT THE ROUTINE ONE YEAR FOLLOW UP. IT WAS FURTHER REPORTED THAT THE POST-IMPLANT OAC REGIMEN WAS XARELTO 20MG, ASPIRIN FOR 45 DAYS, AND PLAVIX. THE MEDICATION REGIMEN WAS NOT FOLLOWED. DRT WAS IDENTIFIED USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND COMPUTED TOMOGRAPHY (CT) IMAGING. THE DRT WAS LOCATED NEAR THE THREADED INSERT OF THE CLOSURE DEVICE AND LAMINAR IN NATURE. THE PHYSICIANS COULD NOT RULE OUT DRT, YET IT LOOKED LIKE HYPO ATTENUATED THICKENING (HAT).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED, AND A WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS PLACED ON AN ORAL ANTICOAGULANT (OAC) MEDICATION REGIMEN. THE PATIENT WAS DISCHARGED. AT THE 45-DAY ROUTINE FOLLOW UP, IMAGING REVEALED A POTENTIAL DEVICE RELATED THROMBUS (DRT). THE PHYSICIANS RECOMMENDED THE PATIENT CONTINUE ON OAC. NO FURTHER INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2498648 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0030553409

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Other