BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 9694669 · Received February 11, 2020

    Report

    Report Number
    2134265-2020-01337
    Event Type
    Death
    Date Received
    February 11, 2020
    Date of Event
    January 1, 2018
    Report Date
    February 11, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    Unique Complaint ID Number,Initial or Supplement,Type of event,TTE in days,Device Brand Name,Medical device identifier,Device Codes;12089805,,D,850;851,WATCHMAN LAA Closure Device & Delivery System,WU2706,2993

    Additional Manufacturer Narrative · 1

    SUMMARY REPORTING EXEMPTION APPROVAL NUMBER: E2017028. THIS REPORT INCLUDES 1 PATIENT ADVERSE EVENT REPORT FOR STROKE AND DEATH. DATE OF EVENT: UNKNOWN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED EVENTS AS PART OF THE LAAO/NCDR REGISTRY FOR THE WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICES, FALLING UNDER THE LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) REGISTRY OF THE AMERICAN COLLEGE OF CARDIOLOGY'S NATIONAL CARDIOVASCULAR DATA REGISTRY (NCDR). THE DATA IS COLLECTED IN ORDER TO ASSESS WHETHER THE RATES OF SAFETY AND EFFECTIVENESS DURING EARLY COMMERCIALIZATION ARE CONSISTENT WITH PREMARKET FINDINGS. BECAUSE LAAOR DATA IS REDACTED BEFORE BEING TRANSMITTED TO BSC, THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED. THE EVENTS ARE MOST LIKELY DUPLICATES WITH POTENTIAL FOR NON-DEVICE RELATED ADVERSE EVENTS INCLUDED. THIS REPORT INCLUDES 1 PATIENT ADVERSE EVENT REPORT FOR STROKE AND DEATH 850 &851 DAYS POST IMPLANT. NO FURTHER INFORMATION IS AVAILABLE TO BSC. THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2017028 FOR PRODUCT CODE NGV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158397 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371

    Patients

    Seq Age Sex Outcome Treatment
    1 Death