BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 22065056 · Received May 21, 2025

    Report

    Report Number
    2124215-2025-32700
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    March 28, 2025
    Report Date
    May 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT: ESTIMATED AS 03/28/2025 AS THE ONLINE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS MARCH 28, 2025. CITATION: HIGGINS, A, ZIMMERMAN, S, WANG, Y. ET AL. LONG-TERM OUTCOMES FOLLOWING LEFT ATRIAL APPENDAGE OCCLUSION IN MEDICARE BENEFICIARIES: OUTCOMES FROM THE NATIONAL CARDIOVASCULAR DATA REGISTRY. JACC. 2025 APR, 85 (12_SUPPLEMENT) 869. HTTPS://DOI.ORG/10.1016/S0735-1097(25)01353-1.

    Description of Event or Problem · 0

    REPORTED VIA LITERATURE ARTICLE: IT WAS REPORTED STROKE(S) OCCURRED. THE NATIONAL CARDIOVASCULAR DATA REGISTRY LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) REGISTRY DATA WAS USED FOR INPATIENT MEDICARE CLAIMS DATA USING DETERMINISTIC MATCHING AND ESTABLISHED A COHORT OF PATIENTS >/=65 YEARS OF AGE WHO UNDERWENT LAAO BETWEEN JANUARY 2016 AND DECEMBER 2019. EVENT FREE SURVIVAL WAS CALCULATED USING THE KAPLAN-MEIER METHOD FOR DEATH AND THE CUMULATIVE INCIDENCE FUNCTION, ACCOUNTING FOR COMPETING RISK OF DEATH, FOR STROKE. RESULTS: A TOTAL OF 34,975 PATIENTS WITH AN AVERAGE AGE 77.5 YEARS (SD 6.5) AND 41.8% FEMALE WERE INCLUDED. THE AVERAGE CHA(2) DS(2)-VASC SCORE WAS 4.7 (SD 1.4). MEDIAN FOLLOW-UP WAS 2.8 YEARS (IQR 2.2-3.7 YEARS). THE INCIDENCE OF ANY STROKE AND ISCHEMIC STROKE WERE 1.80 (95% CI 1.66-94) AND 1.47 (95% CI 1.35-1.59) PER 100 PERSON-YEAR, RESPECTIVELY. THE FIVE-YEAR RATES OF ANY STROKE AND ISCHEMIC STROKE WERE 5.70% (95% CI 5.37-6.05) AND 5.03% (95% CI 4.71-5.36%), RESPECTIVELY. THE INCIDENCE OF DEATH WAS 10.37 (10.05-10.68) PER 100 PERSON-YEARS AND THE FIVE-YEAR MORTALITY RATE WAS 44.34% (95% CI 43.45-45.23%). CONCLUSION: LONG-TERM ISCHEMIC STROKE RATES IN A LARGE NATIONALLY REPRESENTATIVE COHORT OF MEDICARE PATIENTS FOLLOWING WATCHMAN LAAO WERE LOW DESPITE A HIGH EMBOLIC RISK. CITATION: HIGGINS, A, ZIMMERMAN, S, WANG, Y. ET AL. LONG-TERM OUTCOMES FOLLOWING LEFT ATRIAL APPENDAGE OCCLUSION IN MEDICARE BENEFICIARIES: OUTCOMES FROM THE NATIONAL CARDIOVASCULAR DATA REGISTRY. JACC. 2025 APR, 85 (12_SUPPLEMENT) 869. HTTPS://DOI.ORG/10.1016/S0735-1097(25)01353-1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937406 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other