BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 7442747 · Received April 19, 2018

    Report

    Report Number
    2134265-2018-03179
    Event Type
    Death
    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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: MAZZONE, PATRIZIO, ET AL. ¿PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE WITH WATCHMAN DEVICE: RESULTS FROM THE TRAPS REGISTRY¿, EUROPEAN SOCIETY OF CARDIOLOGY(2016) 18:I7. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE INVESTIGATION CONCLUSION IS DEVICE NOT RETURNED AS THE COMPLAINT DID NOT INCLUDE RETURNED DEVICE REVIEW AND LACKED THE OBJECTIVE EVIDENCE OR DESCRIPTIVE CONDITIONS OF THE EVENT REQUIRED TO DETERMINE WHAT COULD HAVE CONTRIBUTED TO THE EVENT. (B)(4). [(B)(4)].

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. SAME ARTICLE AS MDR ID: 2134265-2018-03118. IT WAS REPORTED VIA JOURNAL ARTICLE THAT DURING THE MEDIAN FOLLOW-UP OF 16 MONTH, A PATIENT EXPIRED ON AN UNKNOWN DATE. THE CAUSE OF DEATH WAS ALSO UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288149 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE UNK727

    Patients

    Seq Age Sex Outcome Treatment
    1 Death