BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 22187909 · Received June 11, 2025

    Report

    Report Number
    2124215-2025-38037
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    February 1, 2025
    Report Date
    May 20, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT - ARTICLE PUBLISH DATE USED AS EVENT DATE IS UNKNOWN. 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. D6A IMPLANT DATE WAS REPORTED AS FEBRUARY 1, 2022, THROUGH OCTOBER 31, 2023. LITERATURE CITATION: SULARZ, A., CHAVEZ PONCE, A., AL-ABCHA, A., SIMARD, T., KILLU, A. M., DOSHI, S. K., & ALKHOULI, M. (2025). SAFETY AND FEASIBILITY OF 3D INTRACARDIAC ECHOCARDIOGRAPHY IN GUIDING LEFT ATRIAL APPENDAGE OCCLUSION WITH WATCHMAN FLX. JACC: ADVANCES, 4(2), 101570. HTTPS://DOI.ORG/10.1016/J.JACADV.2024.101570.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT PATIENT ADVERSE EVENTS OCCURRED. THIS PROSPECTIVE MULTICENTER STUDY INVESTIGATED THE FEASIBILITY AND SAFETY OF INTRACARDIAC ECHOCARDIOGRAPHY (ICE) GUIDED LAAO WITH WATCHMAN FLX USING A NOVEL 3-DIMENSIONAL ICE CATHETER. A TOTAL OF 100 PATIENTS UNDERGOING LAAO WITH THE WATCHMAN FLX DEVICE WERE ENROLLED IN THE STUDY BETWEEN FEBRUARY 1, 2022, AND OCTOBER 31, 2023. ALL CASES WERE PERFORMED UNDER MODERATE SEDATION. A SIMPLIFIED 2 ORTHOGONAL VIEW ICE IMAGING PROTOCOL WAS ADOPTED TO ASSESS PASS (POSITION, ANCHORING, SIZING, AND SEALING) CRITERIA. THE FEASIBILITY ENDPOINT WAS SUCCESSFUL IMPLANTATION OF THE FLX DEVICE AND ADEQUATE SEAL (PERI-DEVICE LEAK LESS THAN 5MM) AT 45 DAYS. THE SAFETY ENDPOINT WAS THE INCIDENCE OF MAJOR COMPLICATIONS AT 7 AND 45 DAYS. RESULTS: POSTPROCEDURAL COMPLICATION RATES WERE LOW. THERE WAS 1 CASE OF ISCHEMIC STROKE AND 1 CASE OF PERICARDITIS (TREATED MEDICALLY). FIVE PATIENTS HAD MINOR ACCESS SITE BLEEDING. THERE WAS 1 DEATH SECONDARY TO A MYOCARDIAL INFARCTION AT DAY 33, CONSIDERED UNRELATED TO LAAO. 1 PATIENT HAD A LEAK GREATER THAN 5MM AT 45 DAYS. THERE WERE 2 GASTROINTESTINAL BLEEDS REQUIRING TRANSFUSION AT 7 DAYS WITH NO OTHER MAJOR COMPLICATIONS. A NEW, ASYMPTOMATIC PERICARDIAL EFFUSION WAS DETECTED IN 1 PATIENT AT THE 45 DAY FOLLOW UP WHICH DID NOT REQUIRE PERICARDIAL INTERVENTION. DEVICE RELATED THROMBUS (DRT) WAS NOTED IN 1 PATIENT VIA TEE AND 3 PATIENTS VIA COMPUTED TOMOGRAPHY (CT) AT 45 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205502 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other