BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 20956390 · Received December 17, 2024

    Report

    Report Number
    2124215-2024-79513
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    July 1, 2024
    Report Date
    December 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT - ARTICLE PUBLISH DATE USED AS EVENT DATE IS UNKNOWN. LITERATURE CITATION: NAKASHIMA, M., YAMAMOTO, M., SAGO, M., TANAKA, S., CHATANI, R., ASAMI, M., AND OCEAN-LAAC INVESTIGATORS. (2024). COMPARATIVE DATA OF PROCEDURAL AND MIDTERM OUTCOMES IN PATIENTS WHO UNDERWENT PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE BETWEEN THE WATCHMAN FLX AND WATCHMAN 2.5 DEVICES INSIGHT FROM THE OCEAN-LAAC REGISTRY. CIRCULATION JOURNAL, CJ-24. HTTPS://DOI.ORG/10.1253/CIRCJ.CJ-24-0062.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT SERIOUS INJURIES OCCURRED. LIMITED DATA IS AVAILABLE REGARDING CLINICAL OUTCOMES AFTER PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE USING WATCHMAN FLX AND WATCHMAN 2.5 CLOSURE DEVICES IN ASIAN PATIENTS. RESULTS: DATA OF 1,464 CONSECUTIVE PATIENTS WERE EXTRACTED FROM A JAPANESE MULTICENTER REGISTRY, AND CLINICAL DATA WERE COMPARED BETWEEN THE 2 GROUPS. IN THIS STUDY, THE WM-FLX DEVICE WAS USED IN 909 PATIENTS AND THE WM2.5 DEVICE WAS USED IN 505 PATIENTS. NO IN-HOSPITAL DEATHS, PERIPROCEDURAL STROKE, OR DEVICE EMBOLIZATION OCCURRED. PROCEDURAL COMPLICATIONS THAT OCCURRED WERE SIX (6) PATIENTS EXPERIENCING A PERICARDIAL EFFUSION IMPLANTED WITH A WATCHMAN FLX CLOSURE DEVICE AND THREE (3) PATIENTS EXPERIENCING A PERICARDIAL EFFUSION IMPLANTED WITH THE WATCHMAN 2.5 DELIVERY SYSTEM. NINE (9) PATIENTS EXPERIENCE A PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE IMPLANTED WITH A WATCHMAN FLX CLOSURE DEVICE AND TWO (2) PATIENTS EXPERIENCED A PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE IMPLANTED WITH THE WATCHMAN 2.5 DELIVERY SYSTEM. AT THE ONE (1) YEAR FOLLOW UP AN UNKNOWN NUMBER OF PATIENTS IMPLANTED WITH THE WATCHMAN FLX CLOSURE DEVICE EXPERIENCED PERICARDIAL EFFUSION, PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE, CEREBRAL VASCULAR ACCIDENTS, TRANSIENT ISCHEMIC ATTACK, AND DEVICE RELATED THROMBI. AT THE ONE (1) YEAR FOLLOW UP AN UNKNOWN NUMBER OF PATIENTS IMPLANTED WITH THE WATCHMAN FLX CLOSURE DEVICE EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA). AT THE ONE (1) YEAR FOLLOW UP AN UNKNOWN NUMBER OF PATIENTS IMPLANTED WITH THE WATCHMAN 2.5 CLOSURE DEVICE EXPERIENCED PERICARDIAL EFFUSION, PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE, CEREBRAL VASCULAR ACCIDENTS, AND DEVICE RELATED THROMBI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455598 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention