BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19702945 · Received July 9, 2024

    Report

    Report Number
    2124215-2024-41780
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    May 16, 2024
    Report Date
    July 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED AS 05/16/2024 AS THE PUBLISHED DATE FOR THE POSTER PRESENTATION IS NOTED AS 2024-05-16 TO 2024-05-19. CITATION: ZHANG, C., VINAYAK, M., SALEEM, M., JIA, K., GOLDMAN, M., MUSIKANTOW, DR., LAMPERT, J., MILLER, MA., DUKKIPATI, SR., & REDDY, VY. (2024) PERCUTANEOUS EXTRACTION OF A LARGE ORGANIZED LEFT ATRIAL THROMBUS WITH MECHANICAL ASPIRATION [ABSTRACT]. HEART RHYTHM. 2024; 21 (5 SUPPL): S225-S6. ABSTRACT PO-01-032 HEART RHYTHM 2024 UNITED STATES, BOSTON 2024-05-16 TO 2024-05-19.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE IT WAS REPORTED THAT THE DEVICE DID NOT SEAL, AND THROMBOSIS OCCURRED. A PATIENT WITH CORONARY DISEASE AND PRIOR BYPASS SURGERY, SEVERE MITRAL REGURGITATION WITH BIOPROSTHETIC MITRAL VALVE REPLACEMENT, BI-ATRIAL CRYOMAZE, AND PERSISTENT ATRIAL FIBRILLATION HAD A WATCHMAN FLX CLOSURE DEVICE IMPLANTED AFTER GASTROINTESTINAL BLEEDING REQUIRING TRANSFUSION WHILE ON ORAL ANTICOAGULATION (OAC). A 4MM PERI-DEVICE LEAK WAS CLOSED WITH A NON-BOSTON SCIENTIFIC (BSC) VASCULAR PLUG, AT WHICH POINT OAC WAS HALTED. A 4-MONTH FOLLOW-UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED NO THROMBUS ON THE WATCHMAN, BUT A LARGE, ADHERENT THROMBUS IN THE LEFT ATRIUM (LA). IT WAS INITIALLY RESPONSIVE TO OAC, BUT THE PATIENT DEVELOPED A SPONTANEOUS, LARGE THIGH HEMATOMA PROMPTING CESSATION OF HIGH-DOSE OAC. GIVEN THE STROKE RISK AND SURGICAL CONTRAINDICATIONS, PERCUTANEOUS LA THROMBUS ASPIRATION WAS ATTEMPTED VIA TRANSSEPTAL ACCESS WITH A SENTINEL CEREBRAL PROTECTION. DUE TO ITS FIRM CONSISTENCY, THE MASS WAS DEBULKED PIECE MEAL WITH MECHANICAL SUCTION AND TRACTION; REPEAT TEE REVEALED ONLY MINIMAL RESIDUAL LA THROMBUS. THE PATIENT WAS MAINTAINED ON LOW DOSE APIXABAN. THE PATIENT CONVALESCED WITHOUT COMPLICATIONS (INCLUDING NO STROKE) AND WAS DISCHARGED HOME IN ONE WEEK. HISTOLOGY CONFIRMED FIBRIN CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269411 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention