BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 19247904 · Received May 6, 2024

    Report

    Report Number
    2124215-2024-25956
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    July 22, 2019
    Report Date
    May 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JOURNAL ARTICLE PUBLISHED DATE USED AS EVENT DATE LITERATURE CITATION: FENDER, E ET AL. (JULY 22, 2019). LEFT ATRIAL APPENDAGE PERIDEVICE LEAK PRESENTING WITH STROKE. JACC: CARDIOVASCULAR INTERVENTIONS. 12(14). HTTPS://DOI.ORG/10.1016/J.JCIN.2019.04.033.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE IT WAS REPORTED THAT INCOMPLETE CLOSURE, THROMBUS, AND STROKE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A 30MM WATCHMAN LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS) WAS USED, AND THE CLOSURE DEVICE WAS IMPLANTED. THE PROCEDURE WAS CONCLUDED. THE PATIENT WAS PLACED ON ASPIRIN AND ELIQUIS FOR ORAL ANTICOAGULATION (OAC) MEDICATION REGIMEN. AT THE 45 DAY ROUTINE FOLLOW UP, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A 1 TO 2 MM PERI- CLOSURE DEVICE LEAK, AND THE PATIENT WAS TRANSITIONED TO ASPIRIN AND PLAVIX FOR AN ADDITIONAL 45 DAYS. THREE (3) WEEKS LATER, THE PATIENT PRESENTED WITH APHASIA, RIGHT HEMIPARESIS AND RIGHT HEMISENSORY LOSS AND WAS FOUND TO HAVE A LEFT MIDDLE CEREBRAL ARTERY STROKE. A TEE IDENTIFIED A 3MM LEAK ADJACENT TO THE CLOSURE DEVICE AND A 10 X 9MM MOBILE THROMBUS WITHIN THE LAA. THE PATIENT WAS RESUMED ON THERAPEUTIC OAC WITH WARFARIN. A REPEAT TEE IS PLANNED AFTER THREE (3) MONTHS OF OAC. NO FURTHER INTERVENTIONS OR PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576644 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10365

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Other