BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 13051695 · Received December 21, 2021

    Report

    Report Number
    2134265-2021-16031
    Event Type
    Injury
    Date Received
    December 21, 2021
    Date of Event
    December 14, 2017
    Report Date
    December 21, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729838234
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ASAP TOO STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS ADMINISTERED AND AFTER THE IMPLANT PROCEDURE THE PATIENT WAS STARTED ON CLOPIDOGREL, ASPIRIN WAS CONTINUED. THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A 24 MM WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 17 MM. ONE DAY POST INDEX PROCEDURE, THE PATIENT WAS DISCHARGED. ON (B)(6) 2017, 85 DAYS POST INDEX PROCEDURE AT THE 3 MONTH FOLLOW-UP VISIT, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A THROMBUS ON THE ATRIAL FACING SURFACE OF THE DEVICE. OF NOTE, DURING 3-MONTH CORE LAB TEE FOLLOW-UP VISIT THE THROMBUS WAS NOTED, HOWEVER, PER SITE NO THROMBUS WAS NOTED. THE SIZE OF THE MAXIMUM AREA OF DEVICE THROMBUS 0.42 CM2 AND THE THROMBUS WAS NON MOBILE. DURING THIS TIME, THE PATIENT WAS ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2018, DURING THE 12 MONTH FOLLOW-UP VISIT NO THROMBUS WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953040 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371 0020270378 08714729838234

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other