BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 10267140 · Received July 13, 2020

    Report

    Report Number
    2134265-2020-09113
    Event Type
    Death
    Date Received
    July 13, 2020
    Date of Event
    June 19, 2020
    Report Date
    July 30, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B2 DATE OF DEATH WAS ESTIMATED. THE DATE OF DEATH WAS REPORTED, AS BEING 1 OR 2 DAYS AFTER THE PROCEDURE DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT A PATIENT DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED, AND A WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO REPORTED COMPLICATIONS THAT OCCURRED DURING THE PROCEDURE. LATER THAT EVENING, THE PATIENT HAD AN INTRA-CRANIAL HEMORRHAGE. THE PATIENT THEN PASSED AWAY A DAY OR TWO LATER.

    Additional Manufacturer Narrative · 1

    DATE OF DEATH WAS ESTIMATED. THE DATE OF DEATH WAS REPORTED AS BEING 1 OR 2 DAYS AFTER THE PROCEDURE DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE CLOSRE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. NO COMPLICATIONS WERE REPORTED TO HAVE OCCURRED DURING THE PROCEDURE. LATER THAT EVENING THE PATIENT HAD AN INTRA-CRANIAL HEMORRHAGE. THE PATIENT THEN PASSED AWAY A DAY OR TWO LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732385 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371 0024020258

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death