BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 7001185 · Received November 3, 2017

    Report

    Report Number
    2134265-2017-11171
    Event Type
    Death
    Date Received
    November 3, 2017
    Date of Event
    January 1, 2017
    Report Date
    February 10, 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;A00662967,,D,180,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00662969,,D,190,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00663012,,D,215,WATCHMAN ® LAA Closure Device & Delivery System,WU2106,2993

    Additional Manufacturer Narrative · 1

    SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2017028. THIS SUMMARY REPORT REPRESENTS 3 PATIENTS. THERE IS ONE ROW FOR EACH PRODUCT INVOLVED. IF THERE WERE MULTIPLE PATIENT OUTCOMES, THOSE ARE LISTED AS MULTIPLE PATIENT CODES AND THE TTE LISTS THE DAYS FROM PROCEDURE WHEN THOSE PATIENT OUTCOMES WERE OBSERVED. (B)(4).

    Additional Manufacturer Narrative · 1

    SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2017028. THIS SUPPLEMENTAL REPORT IS BEING FILED AFTER A RETROSPECTIVE REVIEW REQUESTED BY FDA. DATE OF EVENT: UNKNOWN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED EVENTS FOR THE WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICES AS PART OF THE LEFT ATRIAL APPENDAGE OCCLUSION (LAAO); REGISTRY OF THE (B)(6). THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER E2017028 FOR PRODUCT CODE NGV.

    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). THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2017028. THIS SUPPLEMENTAL REPORT IS BEING FILED AS REQUESTED BY FDA TO INCLUDE PATIENT, DEVICE AND EVALUATION CODES IN THIS SUMMARY MARKER REPORT. 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 FOR THESE 3 PATIENTS. THESE EVENTS ARE MOST LIKELY DUPLICATES WITH POTENTIAL FOR NON-DEVICE RELATED ADVERSE EVENTS INCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779121 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371

    Patients

    Seq Age Sex Outcome Treatment
    1 Death