BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 7444711 · Received April 19, 2018

    Report

    Report Number
    2134265-2018-03059
    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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: SAW J, ET AL. (2017). EARLY CANADIAN MULTI-CENTER EXPERIENCE WITH WATCHMAN FOR PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE. J CARDIOVASC ELECTROPHYSIOL, 28, PP. 396-401. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. ONE HUNDRED AND SIX PATIENTS UNDERWENT LAA CLOSURE WITH WATCHMAN ® LAA CLOSURE DEVICE FROM MAY 2013 TO OCT 2015. THE MEAN AGE WAS 74.8 +/- 7.7, MEAN CHADS2 SCORE 2.8 +/- 1.2, CHA2 DS2 -VASC SCORE 4.3+/-1.5, AND HASBLED SCORE 3.2 +/- 1.2. PERMANENT ATRIAL FIBRILLATION (AF) WAS PRESENT IN 67.9% AND PAROXYSMAL AF IN 32.1%. INDICATIONS FOR LAA CLOSURE WERE PRIOR BLEEDING 89.6% (87 MAJOR BLEEDING, AND 8 MINOR BLEEDING), 9.4% WERE DEEMED HIGH-RISK FOR BLEEDING, AND 0.9% WITH RECURRENT STROKES ON WARFARIN. PROCEDURAL SUCCESS WAS 97.2% (103/106), WITH ONE DEVICE EMBOLIZATION (SNARED SUCCESSFULLY PERCUTANEOUSLY). REPEAT DEVICE IMPLANTATION WAS NOT ATTEMPTED. THERE WAS ONE IMPLANT FAILURE DUE TO INADEQUATE LAA DEPTH. AND THERE WAS ONE CARDIAC PERFORATION WITH THE ACCESS SHEATH THAT REQUIRED SURGICAL REPAIR BEFORE WATCHMAN IMPLANTATION; THIS PATIENT DIED 5 DAYS LATER DUE TO SEPSIS. THE COMPOSITE MAJOR SAFETY EVENT-RATE WAS 1.9% (1 DEATH, 1 DEVICE EMBOLIZATION ). THE MEAN HOSPITAL STAY WAS 1.8 +/- 4.7 DAYS. ANTITHROMBOTIC THERAPY POSTIMPLANT INCLUDED DUAL ANTIPLATELET THERAPY IN 76 OF 103 (73.8%). MEAN FOLLOW-UP WAS 210 ± 182 DAYS; THERE WERE TWO TRANSIENT ISCHEMIC ATTACKS, WITH ESTIMATED 66% REDUCTION IN THROMBOEMBOLIC EVENTS RELATIVE TO CHADS2 PREDICTED RISK. OTHER IN-HOSPITAL EVENTS INCLUDED SMALL PERICARDIAL EFFUSION THAT DID NOT REQUIRE DRAINAGE (1.9%), ASYMPTOMATIC HEMOGLOBIN DROP REQUIRING TRANSFUSIONS (1.9%), AND PSEUDOANEURYSM REQUIRING THROMBIN INJECTION (0.9%). THE MEAN FOLLOW-UP DURATION WAS 210.3 ± 182.2 DAYS. THROUGHOUT THE STUDY DURATION, THERE WERE TWO CARDIOVASCULAR DEATHS (1 IN-HOSPITAL DEATH DUE TO CARDIAC PERFORATION AND 1 DUE TO AORTIC DISSECTION UNRELATED TO THE PROCEDURE), TWO NONCARDIOVASCULAR DEATHS, NO STROKE OR SYSTEMIC EMBOLIZATION, TWO TIA EVENTS, ONE MI, AND FIVE MAJOR BLEEDING EVENTS (3 ON DAPT, 1 ON WARFARIN, AND 1 ON ASPIRIN ALONE) FOLLOW-UP DEVICE SURVEILLANCE IMAGING WAS PERFORMED IN 73 WITH TEE AND 31 WITH CARDIAC CT ANGIOGRAPHY. THERE WAS ONLY ONE DEVICE-ASSOCIATED THROMBUS THAT WAS IDENTIFIED, AND THIS PATIENT WAS TREATED WITH OAC WITHOUT SEQUEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288416 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