BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

    MDR report key: 22513219 · Received July 15, 2025

    Report

    Report Number
    2124215-2025-46114
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    November 19, 2024
    Report Date
    July 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT - ARTICLE PUBLISH DATE USED AS EVENT DATE IS UNKNOWN. D4 MODEL NUMBER, D4 LOT NUMBER, D4 EXPIRATION DATE, D4 UNIQUE IDENTIFIER (UDI) # ARE UNKNOWN AS THE INFORMATION WAS NOT PROVIDED IN THE LITERATURE ARTICLE. D6A IMPLANT DATE WAS REPORTED AS BETWEEN (B)(6) 2021 AND (B)(6) 2023.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT THERE WAS A THROMBUS. THIS STUDY WAS AIMED AT ASSESSING 1 YEAR CLINICAL AND TRANSESOPHAGEAL ECHOCARDIOGRAPHIC (TEE) OUTCOMES IN A CONSECUTIVE SERIES OF PATIENTS UNDERGOING LEFT ATRIAL APPENDAGE (LAA) CLOSURE WITH A SINGLE-SEAL (WATCHMAN FIRST GENERATION OR WATCHMAN FLX) OR DUAL- SEAL DEVICE (NON-BOSTON SCIENTIFIC DEVICE). RESULTS: BETWEEN JANUARY 2021 AND JANUARY 2023 47 PATIENTS WERE ENROLLED, WITH PAROXYSMAL, PERSISTENT OR PERMANENT NON VALVULAR ATRIAL FIBRILLATION, A CHA2DS2-VASC SCORE OF 3 AND A HAS-BLED SCORE OF 3, NOT ELIGIBLE FOR LONG-TERM ORAL ANTICOAGULATION. AT ONE (1) YEAR FOLLOW-UP, NO PATIENT REPORTED CLINICAL EVENTS. AT ONE (1) YEAR FOLLOW UP TEE, 1 PATIENT EXHIBITED A PERI-DEVICE LEAK LESS THAN 3MM, WITHOUT ANY CLINICAL EVENT. TWO PATIENTS EXHIBITED DEVICE- RELATED THROMBOSIS (1 WATCHMAN AND 1 NON-BOSTON SCIENT DEVICE). THESE PATIENTS UNDERWENT LONG-TERM IMAGING SURVEILLANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572750 SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other