BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 8651986 · Received May 29, 2019

    Report

    Report Number
    2134265-2019-05719
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 29, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: K K, M S, R M, V L. POST APPROVAL COMMUNITY HOSPITAL EXPERIENCE IN THE UNITED STATES WITH LEFT ATRIAL APPENDAGE CLOSURE DEVICE (WATCHMAN). J STROKE CEREBROVASC DIS. 2018; 27 (9): 2538-42. HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/29857929.

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED VIA JOURNAL ARTICLE THAT DEVICE THROMBUS AND TRANSIENT ISCHEMIC ATTACK OCCURRED. THIS WAS A RETROSPECTIVE CASE SERIES OF 48 PATIENTS CARRIED OUT IN 2 COMMUNITY HOSPITALS IN THE UNITED STATES. PATIENTS WITH NVAF WHO HAD A CHADS2 HIGHER THAN 2 OR CHADS2VASC2 (CONGESTIVE HEART FAILURE, HYPERTENSION, AGE GREATER THAN 75 YEARS, DIABETES MELLITUS, PRIOR STROKE OR TRANSIENT ISCHEMIC ATTACK [TIA] OR THROMBOEMBOLISM, VASCULAR DISEASE, AGE 65-74 YEARS, AND FEMALE GENDER) SCORE OF 3 OR HIGHER AND WERE NOT CANDIDATES FOR LONG-TERM OAC. THESE PATIENTS WERE SELECTED FOR IMPLANTATION OF WATCHMAN DEVICE. THEY WERE FOLLOWED UP AT 45 DAYS, 6 MONTHS, 9 MONTHS, AND 12 MONTHS AFTER IMPLANTATION OF WATCHMAN DEVICE TO ASSESS FOR COMPLICATIONS INVOLVING THE DEVICE AND TO DETERMINE IF ANTICOAGULATION COULD BE DISCONTINUED AT THE 45 DAYS FOLLOW-UP. THEY WERE MONITORED FOR ANY SYSTEMIC THROMBOEMBOLISM WHILE OFF ANTICOAGULATION. RESULTS: THE SUCCESS RATE OF DEVICE IMPLANTATION WAS 98% (48 OF 49). ONLY A SINGLE PATIENT COULD NOT GET WATCHMAN IMPLANTATION BECAUSE OF UNFAVORABLE LEFT ATRIAL APPENDAGE ANATOMY. ACCESS-RELATED AND DEVICE IMPLANTATION-RELATED COMPLICATIONS WERE ZERO (0%). AT 45 DAYS FOLLOW-UP AND END OF FOLLOW-UP DURATION, THE RATE OF THROMBUS FORMATION ON THE WATCHMAN DEVICE WAS 4% (2 OF 48). ONE PATIENT HAD TIA AFTER WARFARIN DISCONTINUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442376 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other