BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 7443327 · Received April 19, 2018

    Report

    Report Number
    2134265-2018-03057
    Event Type
    Injury
    Date Received
    April 19, 2018
    Report Date
    March 23, 2018
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    M110009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: MAKSYM J, ET AL. (2018). DUAL ANTIPLATELET THERAPY IS SAFE AND EFFICIENT AFTER LEFT ATRIAL APPENDAGE CLOSURE. KARDIOL POL, 76(2), PP. 459-463. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE INVESTIGATION CONCLUSION IS ANTICIPATED PROCEDURAL COMPLICATION AS THE EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE, AND/OR DEVICE LABELING. (B)(4).

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. BETWEEN 31 MARCH 2015 AND 06 JUNE 2017, 44 (22 MALES, MEAN AGE 74+/-7.8 YEARS) CONSECUTIVE PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION (NVAF) UNDERWENT LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE USING WATCHMAN ® LAA CLOSURE DEVICE FOLLOWED BY DUAL ANTIPLATELET THERAPY (DAPT) (75 MG ASPIRIN AND 75 MG CLOPIDOGREL). AFTER THE PROCEDURE AND DURING 98 DAYS' FOLLOW-UP INCLUDING TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), PERI-PROCEDURAL COMPLICATIONS AND CLINICAL OUTCOMES WERE INVESTIGATED. THE MEAN CHA(2)DS(2)-VASC SCORE WAS 4.9+/-1.5 AND MEAN HAS-BLED SCORE WAS 3.6+/-0,8. THE MAIN LAAC INDICATION WAS ANTICOAGULATION CONTRAINDICATION WITH HAS-BLED SCORE>/=3 IN 95.5% CASES (AMONG THEM HISTORY OF BLEEDING IN 38 PATIENTS, 90.5%). 36.4% OF PATIENTS HAVE HISTORY OF STROKE OR TRANSIENT ISCHEMIC ATTACK (TIA). THE PROCEDURE WAS SUCCESSFUL IN 97.7%. DURING FOLLOW-UP NEITHER STROKE NOR BLEEDING WERE OBSERVED. IN TWO (4.6%) PATIENTS, FOLLOW-UP TEE REVEALED A SMALL THROMBUS ATTACHED TO THE WATCHMAN DEVICE DURING THE TWO-MONTH FOLLOW-UP PERIOD. THESE PATIENTS WERE TREATED WITH LOW-MOLECULAR-WEIGHT HEPARIN (LMWH) FOR SIX WEEKS, AND SUBSEQUENT TEE WAS ARRANGED. IN BOTH CASES, THE THROMBUS RESOLVED COMPLETELY AND NO CLINICALLY EVIDENT THROMBOEMBOLIC EVENTS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287641 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE UNK727

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention