BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 11021723 · Received December 16, 2020

    Report

    Report Number
    2134265-2020-17841
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    May 1, 2020
    Report Date
    January 5, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT - ESTIMATED BASED ON THE 45-DAY FOLLOW-UP DATE PROVIDED OF EARLY (B)(6)2020.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. AT THE 45-DAY FOLLOW-UP TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), A DEVICE RELATED THROMBUS WAS NOTED ON THE DEVICE. THE PATIENT WAS KEPT ON ORAL ANTICOAGULANT (OAC) FOR ANOTHER MONTH AND A REPEAT TEE WAS PERFORMED. AT THAT TIME THE THROMBUS DID NOT CHANGE SO THE PATIENT WAS CHANGED TO DIRECT ORAL ANTICOAGULANTS (DOAC) AND A REPEAT TEE WAS PERFORMED 4-6 WEEKS LATER. UPON THE REPEAT TEE, THE THROMBUS HAD GROWN SO THE PATIENT CURRENTLY REMAINS ON OAC. IT WAS FURTHER REPORTED THAT THE THROMBUS WAS NON-MOBILE AND ON THE FACE OF THE DEVICE. THE DEVICE LOOKED PROPERLY SEATED AND NO LEAK WAS NOTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: ESTIMATED BASED ON THE AWARE DATE OF (B)(6) 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. AT THE 45-DAY FOLLOW-UP TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), A DEVICE RELATED THROMBUS WAS NOTED ON THE DEVICE. THE PATIENT WAS KEPT ON ORAL ANTICOAGULANT (OAC) FOR ANOTHER MONTH AND A REPEAT TEE WAS PERFORMED. AT THAT TIME THE THROMBUS DID NOT CHANGE SO THE PATIENT WAS CHANGED TO DIRECT ORAL ANTICOAGULANTS (DOAC) AND A REPEAT TEE WAS PERFORMED 4-6 WEEKS LATER. UPON THE REPEAT TEE, THE THROMBUS HAD GROWN SO THE PATIENT CURRENTLY REMAINS ON OAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488310 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371 0024643356

    Patients

    Seq Age Sex Outcome Treatment
    1 Other