BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 16026323 · Received December 21, 2022

    Report

    Report Number
    2124215-2022-53819
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    December 15, 2022
    Report Date
    January 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT - AWARE DATE OF (B)(6) 2022 USED AS EVENT DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT - UPDATED. D6A: IMPLANT DATE - UPDATED. H6: PATIENT CODE CORRECTED FROM MYOCARDIAL INFARCTION E061202 TO ATRIAL FIBRILLATION E060102.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA SOCIAL MEDIA THAT CARDIAC ARREST OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED. ONE WEEK POST IMPLANT, THE PATIENT HAD A HEART ATTACK.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA SOCIAL MEDIA THAT CARDIAC ARREST OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED. ONE WEEK POST IMPLANT, THE PATIENT HAD A HEART ATTACK. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE CHEST PAIN. THEIR BLOOD PRESSURE AND HEART RATE WERE EXTREMELY HIGH. A MYOCARDIAL INFARCTION AND THROMBUS WERE RULED OUT. THEIR LEVELS OF TROPONIN WERE ELEVATED. THE PHYSICIAN DETERMINED THAT THE PATIENT WAS IN ACUTE ATRIAL FIBRILLATION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2840681 WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other