BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 18991861 · Received March 28, 2024

    Report

    Report Number
    2124215-2024-18336
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    October 26, 2023
    Report Date
    March 28, 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 AS 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 SERIOUS INJURIES 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 CLOSURE (LAAC) ABLATION REGISTRY WHO UNDERWENT CONCOMITANT LAAC AND ABLATION AND ALSO HAD SYSTOLIC HEART FAILURE. PROCEDURAL COMPLICATIONS WERE REPORTED IN A TOTAL OF 6 PATIENTS. 4 PATIENTS EXPERIENCED ACUTE DECOMPENSATED HEART FAILURE, 1 PERICARDIAL EFFUSION NOT REQUIRING PERICARDIOCENTESIS, AND ONE AIR EMBOLISM. 3-MONTH POST-PROCEDURAL IMAGING EVALUATION OF PATIENTS WHO UNDERWENT THE COMBINED PROCEDURE WAS ALSO PERFORMED. 3 PATIENTS HAD A DEVICE RELATED THROMBUS (DRT), AND 13 PATIENTS HAD PERI-DEVICE LEAKS </= 5MM. WITH AN AVERAGE OF 27.4 +/- 7.5 MONTHS FOLLOW-UP, 1 STROKE AND 1 MAJOR BLEEDING WERE OBSERVED, AND REHOSPITALIZATION WAS OBSERVED IN 4 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220845 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| H