BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 18504198 · Received January 12, 2024

    Report

    Report Number
    2124215-2024-01330
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    December 1, 2021
    Report Date
    January 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE OPTION STUDY ON (B)(6) 2020 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT DEVICE DID NOT SEAL. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS NOT ADMINISTERED. ALONG WITH A CONCOMITANT ATRIAL FIBRILLATION ABLATION USING PULMONARY VEIN ISOLATION AND MV ISTHMUS LINE WITH CARTO METHOD, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 19 MM. POST IMPLANT, ASPIRIN AND APIXABAN WAS STARTED. ON (B)(6) 2020, THE PATIENT WAS DISCHARGED. ON (B)(6) 2021, 383 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR A ROUTINE 12-MONTH FOLLOW-UP VISIT. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING REVEALED A RESIDUAL JET AROUND THE DEVICE MORE THAN 5MM WITH AN APPROXIMATE ANGLE OF JET AT 30 DEGREES. THE PATIENT WAS PLACED ON 2.5 MG OF RIVAROXABAN, TWICE DAILY. THERE WERE NO PATIENT COMPLICATIONS REPORTED. ON 02-NOV-2022, THE EVENT WAS CONSIDERED AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2100549 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0025668661

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Other