BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 12597851 · Received October 8, 2021

    Report

    Report Number
    2134265-2021-12588
    Event Type
    Injury
    Date Received
    October 8, 2021
    Date of Event
    February 10, 2021
    Report Date
    October 8, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729838241
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6).

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. ON (B)(6) 2021, 782 DAYS POST INDEX PROCEDURE, THE PATIENT WAS NOTED WITH THE CHIEF COMPLAINT OF RIGHT FACE WEAKNESS AND THE INABILITY TO SPEAK. THE PATIENT'S HEALTH CONDITION CONTINUED TO DECLINE EVEN AFTER ALL THE MEDICAL TREATMENT AND NOTED WITH FLUCTUATION IN THE MENTAL STATUS. A STROKE CODE WAS CALLED. THE PATIENT WAS NOT A GOOD CANDIDATE FOR TPA DUE TO ACTIVE GASTROINTESTINAL BLEEDING AND WAS ALSO NOT A CANDIDATE FOR MECHANICAL THROMBECTOMY DUE TO PHYSICAL MEDICAL CONDITION. THE NEUROLOGIST WAS CONSULTED, AND IT WAS SUSPECTED THAT THE PATIENT HAD SUFFERED A LEFT MCA TERRITORY STROKE AND SUFFERED MULTIPLE STROKES IN BOTH HEMISPHERES BUT THAT REMAINED TO BE DETERMINED. THE NEUROLOGIST SUSPECTED THE EVENT WAS POSSIBLY RELATED TO LARGE VESSEL ATHEROSCLEROTIC DISEASE OR SOME OTHER MECHANISM. THE INITIAL COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD WITHOUT CONTRAST WAS UNREMARKABLE FOR ACUTE INTRACRANIAL PROCESS AND MILD ATROPHY WITH MODERATE WHITE MATTER DISEASE. THE NEUROLOGIST RECOMMENDED TO UNDERGO CT SCAN OF THE BRAIN TO DETERMINE THE ETIOLOGY OF THE STROKE, TRANSESOPHAGEAL ECHO, CAROTID ULTRASOUND, IF POSSIBLE, MRI SINCE THE PATIENT HAD A PACEMAKER AND ADVISED TO CONTINUE ON CARDIAC TELEMETRY. THE DURATION OF FOCAL OR GLOBAL NEUROLOGICAL DEFICIT WAS LESS THAN 24 HOURS IN CASE OF IMAGING-DOCUMENTED NEW HEMORRHAGE OR INFARCT. ON (B)(6) 2021, 783 DAYS POST INDEX PROCEDURE, THE PATIENT DIED DUE TO SHOCK. AS PER THE DEATH CERTIFICATE, THE IMMEDIATE CAUSE OF DEATH WAS ASYSTOLE AND SEQUENTIAL CAUSE OF DEATH WAS INFECTION. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493771 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371 0021925116 08714729838241

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other