BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 18987816 · Received March 27, 2024

    Report

    Report Number
    2124215-2024-18333
    Event Type
    Death
    Date Received
    March 27, 2024
    Date of Event
    October 26, 2023
    Report Date
    March 27, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED AS 10/26/2023 AS THE PUBLISHED DATE FOR THE ARTICLE IS NOTED 26 OCTOBER 2023 CITATION: SUN, J.; ZHANG, R.; YANG, M.; LI, W.; ZHANG, P.-P.; MO, B.-F.;WANG, Q.-S.; CHEN, M.; LI, Y.-G. COMBINED RADIOFREQUENCY ABLATION AND LEFT ATRIAL APPENDAGE CLOSURE IN ATRIAL FIBRILLATION AND SYSTOLIC HEART FAILURE. DIAGNOSTICS 2023, 13, 3325. HTTPS://DOI.ORG/10.3390/ DIAGNOSTICS13213325

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT PATIENT DEATH OCCURRED. THE FOLLOWING EVENT WAS OBTAINED VIA A RETROSPECTIVE ARTICLE FOLLOWING 802 PATIENTS WHO HAD THE WATCHMAN LAA CLOSURE DEVICE IMPLANTED IN THE LEFT ATRIAL APPENDAGE (LAA) LAACABLATION REGISTRY WHO UNDERWENT CONCOMITANT LAAC AND ABLATION AND ALSO HAD SYSTOLIC HEART FAILURE. WITH AN AVERAGE OF 27.4 +/- 7.5 MONTHS FOLLOW-UP, DEATH WAS OBSERVED IN 3 PATIENTS INCLUDING TWO CARDIOVASCULAR DEATHS AND ONE DEATH FROM PANCREATIC CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130025 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death