BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 18969208 · Received March 25, 2024

    Report

    Report Number
    2124215-2024-17444
    Event Type
    Injury
    Date Received
    March 25, 2024
    Date of Event
    January 1, 2020
    Report Date
    March 25, 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

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT - ARTICLE DATE YEAR OF 01JAN2020 USED AS EVENT DATE IS UNKNOWN. LITERATURE CITATION: IMMOHR, M., SUGIMURA, Y., LICHTENBERG, A., AKHYARI, P. ATRIAL THROMBOSIS CAUSED BY A DISLOCATED LEFT ATRIAL APPENDAGE CLOSURE DEVICE AFTER MITRAL VALVE REPLACEMENT. JACC: CASE REPORTS, VOLUME 2, ISSUE 15, 2020, PAGES 2327-2330. HTTPS://DOI.ORG/10.1016/J.JACCAS.2020.05.096

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE ARTICLE THAT A DEVICE MOVEMENT, MYOCARDIAL INFARCTION, AND THROMBOSIS OCCURRED. IN 2015, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A WATCHMAN LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). IN 2019 THE PATIENT UNDERWENT MITRAL VALVE SURGERY VIA RIGHT ANTEROLATERAL MINI-THORACOTOMY DUE TO SEVERE FUNCTIONAL MITRAL VALVE REGURGITATION FOLLOWED BY A BIOPROSTHETIC MITRAL VALVE REPLACEMENT PROCEDURE. THE PATIENT WAS INSTRUCTED TO TAKE ENOXAPARIN AND ASPIRIN FOR THREE (3) MONTHS POST PROCEDURALLY. FOUR (4) MONTHS LATER, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH PALPITATIONS AND DYSPNEA. A NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION AND TACHYCARDIA WERE IDENTIFIED. CORONARY CATHETERIZATION SHOWED NO RELEVANT STENOSIS OR ACUTE EMBOLISM OF THE CORONARY ARTERIES AND CARDIAC MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED. CARDIAC MRI DISPLAYED POSTERIOR WALL INFARCTION, MOST LIKELY CAUSED BY PREVIOUS TRANSIENT THROMBOEMBOLISM. IN ADDITION, A NEW ONSET IMPAIRMENT OF LEFT VENTRICULAR FUNCTION WAS FOUND. THE WATCHMAN CLOSURE DEVICE WAS DISLOCATED WITH A LARGE ADHERENT THROMBUS IN THE LEFT ATRIUM. HEPARIN AND BETA BLOCKERS WERE ADMINISTERED. A LEFT ATRIAL THROMBECTOMY WERE PERFORMED AND IT WAS DISCOVERED THE THROMBUS FILLED MORE THAN FIFTY PERCENT OF THE LEFT ATRIAL CAVITY WITH DIFFERENT STAGE OF THROMBOGENESIS PRESENT. THE THROMBUS WAS ATTACHED TO THE ATRIAL WALL AND THE WATCHMAN CLOSURE DEVICE. THE CLOSURE DEVICE WAS EXPLANTED, AND THE LEFT ATRIAL APPENDAGE WAS SURGICALLY REMOVED ALONG WITH THE THROMBOTIC MASS. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR RECOVERY AND DISCHARGED SEVEN (7) DAYS POST EXPLANT PROCEDURE ON RIVAROXABAN AND CLOPIDOGREL. THREE (3) MONTHS POST THROMBECTOMY ECHOCARDIOGRAPHY INDICATED NO RECURRENCE OF THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500483 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention| H