BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 20441111 · Received October 14, 2024

    Report

    Report Number
    2124215-2024-63418
    Event Type
    Injury
    Date Received
    October 14, 2024
    Date of Event
    July 23, 2024
    Report Date
    October 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOU Q, JIANG C, LIN P, YU Y, LI J, ZHAO F, HU H AND SUN S (2024) MANAGEMENT OF COMPLICATIONS ASSOCIATED WITH PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE WITH OR WITHOUT ABLATION: EXPERIENCE FROM 512 CASES OVER A 4- YEAR PERIOD. FRONT. CARDIOVASC. MED. 11:1388024. DOI: 10.3389/FCVM.2024.1388024.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT CARDIAC PERFORATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 21MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PHYSICIAN POSITIONED THE WAS IN THE LAA OF THE PATIENT AND THEN INSERTED THE WDS. THE CLOSURE DEVICE WAS DEPLOYED IN THE PATIENT BUT WAS IN A SUB OPTIMAL POSITION. WHILE THE PHYSICIAN WAS RECAPTURING THE CLOSURE DEVICE, THEY PERFORATED THE LAA WHICH RESULTED IN A PERICARDIAL EFFUSION. THE PHYSICIAN DEPLOYED THE CLOSURE DEVICE A SECOND TIME IN THE LAA WHICH HELPED WITH THE BLEEDING FROM THE PERFORATION. THE CLOSURE DEVICE MET ALL RELEASE CRITERIA AND WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. THERE WERE NO OTHER COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS DISCHARGED ON RIVAROXABAN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810079 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other