BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 13805167 · Received March 18, 2022

    Report

    Report Number
    2134265-2022-03068
    Event Type
    Injury
    Date Received
    March 18, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 29, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H6: PATIENT CODE HAS BEEN UPDATED FROM CVA TO NO CLINICAL SIGNS, SYMPTOMS, OR CONDITIONS AND THIS EVENT IS NO LONGER A COMPLAINT.

    Description of Event or Problem · 0

    OPTION STUDY. IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS SUCCESSFULLY PERFORMED USING A 27 MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). POST PROCEDURE, ASPIRIN WAS STARTED AND APIXABAN WAS CONTINUED. ON (B)(6) 2019, THE PATIENT WAS DISCHARGED. ON (B)(6) 2022, 867 DAYS POST INDEX PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR A CEREBRAL VASCULAR ACCIDENT (CVA). THE PATIENT WAS TAKING APIXABAN AT THE TIME OF THE EVENT. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Description of Event or Problem · 0

    OPTION STUDY. IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS SUCCESSFULLY PERFORMED USING A 27 MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). POST PROCEDURE, ASPIRIN WAS STARTED AND APIXABAN WAS CONTINUED. ON (B)(6) 2019, THE PATIENT WAS DISCHARGED. ON (B)(6) 2022, 867 DAYS POST INDEX PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR A CEREBRAL VASCULAR ACCIDENT (CVA). THE PATIENT WAS TAKING APIXABAN AT THE TIME OF THE EVENT. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15473 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10393 0022800010

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other