BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 15258089 · Received August 19, 2022

    Report

    Report Number
    2124215-2022-31353
    Event Type
    Death
    Date Received
    August 19, 2022
    Date of Event
    June 1, 2018
    Report Date
    August 19, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF DEATH - ESTIMATED AS (B)(6) 2018 AS THE DATE RANGE IS FROM JUNE 2018 TO MAY 2021. DATE OF EVENT - ESTIMATED AS (B)(6) 2018 AS THE DATE RANGE IS FROM JUNE 2018 TO MAY 2021. (B)(6). LITERATURE CITATION: GALEA R, DE MARCO F, MENEVEAU N, AMINIAN A, ANSELME F, GRANI C, HUBER AT, TEIGER E, IRIART X, BABONGO BOSOMBO F, HEG D, FRANZONE A, VRANCKX P, FISCHER U, PEDRAZZINI G, BEDOGNI F, RABER L, VALGIMIGLI M. AMULET OR WATCHMAN DEVICE FOR PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE: PRIMARY RESULTS OF THE SWISS-APERO RANDOMIZED CLINICAL TRIAL. CIRCULATION. 2022 MAR 8;145(10):724-738. DOI: 10.1161/CIRCULATIONAHA.121.057859. EPUB 2021 NOV 6. PMID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT A DEATH OCCURRED. LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURES WERE PERFORMED FOR 110 PATIENTS BETWEEN JUNE 2018 AND MAY 2021. A WATCHMAN FLX LAA CLOSURE DEVICE WAS USED FOR 85 PATIENTS AND A WATCHMAN 2.5 CLOSURE DEVICE WAS USED FOR 25 PATIENTS BEFORE OCTOBER 2019. THIS WAS SCREENED ACROSS 8 EUROPEAN HEALTH CENTERS. THE PRIMARY END POINT OF THE STUDY WAS DETECTED VIA COMPUTED TOMOGRAPHY ANGIOGRAPHY (CCTA) AT 45 DAYS AND THE SECONDARY END POINT OF THE STUDY INCLUDED ANY PROCEDURAL COMPLICATIONS AND CLINICAL OUTCOMES AT 45 DAYS. THE MEAN PATIENT AGE WAS 77.3 YEARS WITH A MEAN CHA2DS2-VASC SCORE OF 4.4 AND HAS BLED SCORE OF 3.2. THERE WERE 77 MALES AND 33 FEMALES IN THE WATCHMAN STUDY GROUP. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PERFORMED AT 45 DAYS IDENTIFIED THAT PERI-DEVICE LEAKS OCCURRED IN 27.5% OF PATIENTS, HOWEVER, NO LEAKS WERE GREATER THAN 5MM. DEVICE RELATED THROMBUS WAS FOUND IN 3 PATIENTS AT CCTA AND 5 PATIENTS AT TEE. THE SECONDARY END POINT OF THE STUDY AT 45 DAYS WAS MEASURED. DEATHS OCCURRED IN 4 PATIENTS WITH 3 BEING DUE TO FATAL BLEEDING. THE EVENTS LEADING TO DEATH WERE A HEMORRHAGIC STROKE AT 30 DAYS, HEMORRHAGIC TRANSFORMATION OF AN ISCHEMIC STROKE FOLLOWING THROMBOLYSIS 24 DAYS POST LAAC, 1 HEMORRHAGIC SHOCK 10 DAYS POST LAAC, AND 1 SUDDEN DEATH AT HOME 30 DAYS POST LAAC. THE WATCHMAN STUDY GROUP ALSO SAW 25 BLEEDING EVENTS, 8 ONSET PERICARDIAL EFFUSIONS, 2 STROKES, AND 5 VASCULAR ACCESS SITE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069942 WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death