BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 6293068 · Received February 1, 2017

    Report

    Report Number
    2134265-2017-00166
    Event Type
    Death
    Date Received
    February 1, 2017
    Date of Event
    December 20, 2016
    Report Date
    January 3, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA# OR 510K# UPDATED FROM M110009 TO P130013. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WAS NO 45 DAY TREANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AS SHE WAS HOSPITALIZED AND CRITICALLY ILL WITH OTHER ISSUES DURING THIS TIME. SHE WAS READMITTED IN (B)(6) 2016 WITH ABDOMINAL PAIN. SHE HAD PARTIAL BOWEL OBSTRUCTION AND PNEUMONIA AND PASSED AWAY IN (B)(6) 2016 10 DAYS AFTER SHE WAS READMITTED TO THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED A DEATH OCCURRED. THE PATIENT HAD A PRE-EXISTING GASTROINTESTINAL (GI) ISSUE. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED IN (B)(6) 2016. AFTER THE 45 DAY FOLLOW UP, THE PATIENT HAD A COMPLICATION AND DIED. IT WAS REPORTED TO US THAT THE PATIENT DID NOT SUFFER A STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76781 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WU30060 19077244

    Patients

    Seq Age Sex Outcome Treatment
    1 Death