BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 6332503 · Received February 15, 2017

    Report

    Report Number
    2134265-2017-01062
    Event Type
    Death
    Date Received
    February 15, 2017
    Date of Event
    November 8, 2016
    Report Date
    January 26, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT EXPIRED. IN (B)(6) 2013, A 21 MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM WAS SUCCESSFULLY IMPLANTED DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. THERE WERE NO RECAPTURES PERFORMED DURING THE PROCEDURE AND A COMPLETE SEAL OF THE LAA WAS OBSERVED. IN (B)(6) 2016, IT WAS REPORTED THAT THE PATIENT EXPIRED. THE CAUSE OF THE DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2016, THE PATIENT EXPERIENCED CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). NO ADDITIONAL ACTIONS OR DIAGNOSTICS WERE PERFORMED. THE EVENT WAS NOT CONSIDERED RELATED TO THE DEVICE OR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116029 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WS21060

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death