BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

    MDR report key: 22922566 · Received August 29, 2025

    Report

    Report Number
    2124215-2025-60725
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    January 1, 2025
    Report Date
    August 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: LITERATURE DATE USED AS EVENT DATE, AS EVENT DATES ARE UNKNOWN. D1: BRAND NAME IS BLANK BECAUSE THE DEVICE IS KNOWN TO BE A WATCHMAN LAA CLOSURE DEVICE, BUT THE EXACT BRAND NAME IS UNKNOWN. D4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LITERATURE CITATION: GAHONA, C.T. ET AL (JAN 1, 2025). PERCUTANEOUS LEFT ATRIAL APPENDAGE OCCLUSION AND PERIPROCEDURAL OUTCOMES TREND IN THE UNITED STATES: AN INSIGHT FROM NATIONWIDE READMISSION DATABASE 2016-2019. DOI: 10.2139/SSRN.5212839.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT SERIOUS INJURIES OCCURRED. THE FOLLOWING EVENT WAS OBTAINED VIA A RETROSPECTIVE ARTICLE FOLLOWING 54,903 PROCEDURES PERFORMED ON PATIENTS WHO UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WHERE WATCHMAN CLOSURE DEVICES WERE IMPLANTED DURING THE TIME FRAME OF JANUARY 2016 THROUGH DECEMBER 2019. IT WAS REPORTED THE FOLLOWING SERIOUS INJURIES OCCURRED: PERI-PROCEDURAL STROKES, ACUTE KIDNEY INJURY, CARDIAC ARREST, CARDIOGENIC SHOCK, RESPIRATORY FAILURE, SYSTEMIC EMBOLIZATION, ACUTE MYOCARDIAL INFARCTION, COMPLETE HEART BLOCK, BLEEDING RELATED COMPLICATIONS WHICH INCLUDED MAJOR BLEEDS, GASTROINTESTINAL, CENTRAL NERVOUS SYSTEM, AND BLEEDING DUE TO CARDIAC TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2222566 SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R| H