BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 15182437 · Received August 8, 2022

    Report

    Report Number
    2134265-2022-07780
    Event Type
    Injury
    Date Received
    August 8, 2022
    Date of Event
    January 1, 2022
    Report Date
    August 8, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TURAGAM MK, DOSHI SK, KAWAMURA I, DUKKIPATI SR, HALA P, NEUZIL P, REDDY VY. INCIDENCE AND OUTCOMES OF PATIENTS WITH WATCHMAN FLX "FLUTTERING". JACC CLIN ELECTROPHYSIOL. 2022 JUN;8(6):822-823. DOI: 10.1016/J.JACEP.2022.02.010. EPUB 2022 APR 27. PMID: (B)(6). DATE OF EVENT - ESTIMATED AS (B)(6) 2022 SINCE THIS IS WHEN THE ARTICLE WAS PUBLISHED. IMPLANT DATE - ESTIMATED AS (B)(6) 2021 SINCE THIS WAS 1 YEAR PRIOR TO THE ESTIMATED EVENT. DATE WITH THE ALLEGATION OCCURRING AT THE 1 YEAR FOLLOW UP APPOINTMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT THE CLOSURE DEVICE DID NOT SEAL. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED. ONE YEAR FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING REVEALED FLUTTERING OF THE CLOSURE DEVICE FABRIC AND A 5MM LEAK INTO A PARTIALLY UN-THROMBOSED CAVITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2532024 WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other