BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19930144 · Received August 7, 2024

    Report

    Report Number
    2124215-2024-44946
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    July 12, 2024
    Report Date
    August 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL MEDIA WAS PROVIDED TO AID IN THE INVESTIGATION AND WAS REVIEWED BY A BSC QUALITY ENGINEER. THE MEDIA PROVIDED DID NOT APPEAR TO DEPICT ANY DEVICE OR USER RELATED ALLEGATIONS AND RESULTED IN NO QUESTIONS REQUIRING FURTHER INVESTIGATION. H6: CODE UPDATED FROM CMC-NO PROBLEM DETECTED TO KNOWN INHERENT RISK OF DEVICE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED UNDER TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING, AND A 31 WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS PLACED ON ELIQUIS ORAL ANTICOAGULANT (OAC) REGIMEN. AT THE 45-DAY ROUTINE FOLLOW-UP, COMPUTED TOMOGRAPHY (CT) IMAGING REVEALED A DEVICE RELATED THROMBUS (DRT) COVERING THE TOP OF THE CLOSURE DEVICE. THE CLOSURE DEVICE REMAINED COMPLETELY SEALING THE LAA. THE PATIENT REPORTED STOPPING ELIQUIS TWO (2) WEEKS AFTER THE INDEX PROCEDURE AND NOT FOLLOWING POST PROCEDURE INSTRUCTIONS. THE PHYSICIANS RESUMED THE OAC REGIMEN 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 UNDER TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING, AND A 31 WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS PLACED ON ELIQUIS ORAL ANTICOAGULANT (OAC) REGIMEN. AT THE 45-DAY ROUTINE FOLLOW-UP, COMPUTED TOMOGRAPHY (CT) IMAGING REVEALED A DEVICE RELATED THROMBUS (DRT) COVERING THE TOP OF THE CLOSURE DEVICE. THE CLOSURE DEVICE REMAINED COMPLETELY SEALING THE LAA. THE PATIENT REPORTED STOPPING ELIQUIS TWO (2) WEEKS AFTER THE INDEX PROCEDURE AND NOT FOLLOWING POST PROCEDURE INSTRUCTIONS. THE PHYSICIANS RESUMED THE OAC REGIMEN IN RESPONSE TO THE DRT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560460 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0032535204 08714729860518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other