BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 6405398 · Received March 15, 2017

    Report

    Report Number
    2134265-2017-02500
    Event Type
    Injury
    Date Received
    March 15, 2017
    Report Date
    February 20, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    M110009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: HÄNER, J.D. & SEILER, C. J THROMB THROMBOLYSIS (2017) 43: 130. DOI:10.1007/S11239-016-1453-1. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT DEVICE THROMBUS OCCURRED. A PATIENT UNDERWENT ROUTINE TRANSESOPHAGEAL ECHOCARDIOGRAPHY 5 MONTHS AFTER CLOSURE OF THE LEFT ATRIAL APPENDAGE (LAA) USING A WATCHMAN DEVICE AS AN ALTERNATIVE STROKE PREVENTION STRATEGY IN ATRIAL FIBRILLATION AND FOLLOWING SEVERAL BLEEDING COMPLICATIONS UNDER ORAL ANTICOAGULATION FROM AN UROTHELIAL CARCINOMA. IMMEDIATELY AFTER CLOSURE OF THE LAA ORAL ANTICOAGULATION HAD BEEN STOPPED AND THE PATIENT REMAINED UNDER ACETYLIC SALICYLIC ACID. BESIDES PAROXYSMAL ATRIAL FIBRILLATION, HE HAD A HISTORY OF CORONARY ARTERY DISEASE WITH CORONARY ARTERY GRAFTING 18 YEARS AND MYOCARDIAL INFARCTION 10 YEARS AGO AND A MODERATE AORTIC STENOSIS. FIVE MONTHS BEFORE, A THREE-CHAMBER PACEMAKER WAS IMPLANTED FOR CARDIAC RESYNCHRONIZATION THERAPY (CRT) FOR SEVERELY REDUCED SYSTOLIC LEFT VENTRICULAR FUNCTION AND LEFT BUNDLE BRANCH BLOCK. THE ACTUAL TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED TWO INTRA-CARDIAC THROMBI. THE LARGER THROMBUS WAS ATTACHED TO THE RIGHT VENTRICULAR CRT-LEAD AND SITUATED IN THE RIGHT ATRIUM. THE SECOND THROMBUS ADHERED TO THE LAA CLOSURE DEVICE IN THE LEFT ATRIUM AND MEASURED 9X10 MM. A PATENT FORAMEN OVALE WAS EXCLUDED. THE SIMULTANEOUS APPEARANCE OF TWO THROMBI IN THE LEFT AND THE RIGHT ATRIUM WAS ASSUMED TO BE CAUSED BY INCREASED, POSSIBLY PARANEOPLASTIC, HYPERCOAGULABLE CONDITIONS IN THIS PATIENT SUFFERING FROM UROTHELIAL CARCINOMA. THE PRESENTED PATIENT WAS REFERRED TO THE REGIONAL HOSPITAL FOR THE INITIATION OF AN ANTICOAGULATION USING (LOW-MOLECULAR WEIGHT) HEPARINS, IN ACCORDANCE TO CURRENT RECOMMENDATIONS ON THE TREATMENT OF CANCER-ASSOCIATED VTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190455 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE UNK727

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other