BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 7379458 · Received March 28, 2018

    Report

    Report Number
    2134265-2018-03112
    Event Type
    Injury
    Date Received
    March 28, 2018
    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

    Additional Manufacturer Narrative · 0

    SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2017028 THIS SUPPLEMENTAL REPORT IS BEING FILED AFTER A RETROSPECTIVE REVIEW REQUESTED BY FDA TO INCLUDE H6 CODES IN THE SUMMARY 3500A. DATE OF EVENT: UNKNOWN.

    Description of Event or Problem · 0

    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 21 PATIENTS. THESE EVENTS ARE MOST LIKELY DUPLICATES WITH POTENTIAL FOR NON-DEVICE RELATED ADVERSE EVENTS INCLUDED.

    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;A00695686,,SI,392,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00695689,,SI,373,WATCHMAN ® LAA Closure Device & Delivery System,WU3306,2993;A00695690,,SI,211,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00695695,,SI,246,WATCHMAN ® LAA Closure Device & Delivery System,WU3306,2993;A00695679,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00695759,,SI,70,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00695682,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00695760,,SI,42,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00695762,,SI,349,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00695763,,SI,414,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00695765,,SI,309,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00695766,,SI,204,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00695696,,SI,124,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00695768,,SI,385,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00695707,,SI,293,WATCHMAN ® LAA Closure Device & Delivery System,WU3306,2993;A00695708,,SI,363,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00695709,,SI,293,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00695711,,SI,364;379,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00695776,,SI,321,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00695716,,SI,227,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00695717,,SI,354,WATCHMAN ® LAA Closure Device & Delivery System,WU2106,2993

    Additional Manufacturer Narrative · 1

    SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2017028. THIS SUMMARY REPORT REPRESENTS 19 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).

    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 FOR PRODUCT CODE NGV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219554 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371

    Patients

    Seq Age Sex Outcome Treatment
    1 Other