BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 5015672 · Received August 19, 2015

    Report

    Report Number
    2134265-2015-05515
    Event Type
    Death
    Date Received
    August 19, 2015
    Date of Event
    June 4, 2015
    Report Date
    July 24, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    M110009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE, DESCRIBE EVENT OR PROBLEM, OTHER RELEVANT HISTORY: UPDATED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE CAUSE OF DEATH WAS PULMONARY EMBOLISM WHICH IS NOT LIKELY RELATED TO THE WATCHMAN DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED A PATIENT DEATH OCCURRED. IN (B)(6) 2015, THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE AND AN UNKNOWN SIZE WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. ON AN UNKNOWN DATE, THE PATIENT DIED. THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547060 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE UNK727

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death