BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 17646314 · Received August 29, 2023

    Report

    Report Number
    2124215-2023-45429
    Event Type
    Injury
    Date Received
    August 29, 2023
    Date of Event
    August 20, 2023
    Report Date
    September 1, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT - AWARE DATE OF 20AUG2023 USED AS EVENT DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT - AWARE DATE OF 20AUG2023 USED AS EVENT DATE IS UNKNOWN. D6A IMPLANT DATE - UPDATED. E1 INITIAL REPORTER INFORMATION - UPDATED. G2 REPORT SOURCE - UPDATED.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT ORIGINATED FROM SOCIAL MEDIA, AND THEREFORE DESPITE GOOD FAITH EFFORTS THE INFORMATION IS OFTEN INCOMPLETE. ADDITIONALLY, DUE TO THE LIMITED INFORMATION RECEIVED THROUGH GOOD FAITH EFFORTS, THIS EVENT MAY REPRESENT A DUPLICATE OF AN EVENT WHICH WAS ALREADY KNOWN TO BOSTON SCIENTIFIC. IT WAS REPORTED VIA SOCIAL MEDIA THAT MULTIPLE TRANSIENT ISCHEMIC ATTACKS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). APPROXIMATELY ONE YEAR POST INDEX PROCEDURE, THE PATIENT EXPERIENCED SEVERAL TRANSIENT ISCHEMIC ATTACKS AND ATRIAL FIBRILLATION. THE PATIENT WAS INSTRUCTED TO RESUME ANTICOAGULATION MEDICATION.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT ORIGINATED FROM SOCIAL MEDIA, AND THEREFORE DESPITE GOOD FAITH EFFORTS THE INFORMATION IS OFTEN INCOMPLETE. ADDITIONALLY, DUE TO THE LIMITED INFORMATION RECEIVED THROUGH GOOD FAITH EFFORTS, THIS EVENT MAY REPRESENT A DUPLICATE OF AN EVENT WHICH WAS ALREADY KNOWN TO BOSTON SCIENTIFIC. IT WAS REPORTED VIA SOCIAL MEDIA THAT MULTIPLE TRANSIENT ISCHEMIC ATTACKS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). APPROXIMATELY ONE YEAR POST INDEX PROCEDURE, THE PATIENT EXPERIENCED SEVERAL TRANSIENT ISCHEMIC ATTACKS AND ATRIAL FIBRILLATION. THE PATIENT WAS INSTRUCTED TO RESUME ANTICOAGULATION MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082711 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other