BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 11289011 · Received February 5, 2021

    Report

    Report Number
    2134265-2021-01122
    Event Type
    Injury
    Date Received
    February 5, 2021
    Date of Event
    January 14, 2021
    Report Date
    October 26, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729838234
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER - (B)(6).

    Description of Event or Problem · 0

    (B)(6). IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT OCCURRED. THE SUBJECT WAS ON ASPIRIN MEDICATION PRIOR TO CONSENT AND SCREENING FOR THE STUDY. THE SUBJECT WAS UNSUITABLE FOR ORAL ANTICOAGULANT'S (OAC'S) DUE TO OTHER CLINICALLY RELEVANT ORGAN BLEEDING GASTROINTESTINAL LESIONS. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 20.3MM. AFTER THE IMPLANT THE SUBJECT WAS STARTED ON ASPIRIN AND CLOPIDOGREL. THE SUBJECT WAS DISCHARGED ON (B)(6) 2018. ON (B)(6) 2021, 911 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF DOUBLE VISION AND GAIT INSTABILITY. THE SUBJECT DENIED WEAKNESS, NUMBNESS, CHANGE IN SPEECH AND TRAUMA. AT THE TIME OF REPORTING, THE SUBJECT WAS NOT ON ANTICOAGULATION OR ANTIPLATELET MEDICATION. THE SUBJECT WAS STOPPED ON ELIQUIS FOR ATRIAL FIBRILLATION SINCE THE SUBJECT HAD ANEMIA OF UNCLEAR ORIGIN. THE SUBJECT WAS STARTED ON TISSUE PLASMINOGEN ACTIVATOR (TPA). ON (B)(6) 2021, A COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD WITHOUT CONTRAST WAS PERFORMED AND A CT SCAN ANGIOGRAPHY OF THE HEAD AND NECK INCLUDING MAXIMUM INTENSITY PROJECTION (MIP) RECONSTRUCTION WAS PERFORMED. UPON DISCUSSION WITH NEUROLOGIST THE SUBJECT WAS TRANSFERRED AND MONITORED IN THE INTENSIVE CARE UNIT. THE SUBJECT WAS RECOMMENDED TO FOLLOW UP WITH VASCULAR SURGERY, BUT THE SURGERY WAS DECLINED DUE TO STENOSIS <70% AND WAS ADVISED TO MANAGE MEDICALLY. ON (B)(6) 2021, AN X-RAY OF THE CHEST AND A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED. ON THE SAME DAY, AN MRI OF THE BRAIN WITHOUT INTRAVENOUS CONTRAST REVEALED NO ACUTE INFRACTION OR HEMORRHAGE. THE EVENT WAS CLASSIFIED AS ISCHEMIC STROKE. THE SUSPECTED CAUSE WAS CHRONIC CALCIFIC ATHEROSCLEROTIC PLAQUE. THE SUBJECT WAS RECOMMENDED TO FOLLOW UP AS AN OUTPATIENT FOR SCHEDULED NEUROLOGY AND CARDIOLOGY CONSULT. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED HOME ON ASPIRIN, CLOPIDOGREL AND OTHER MEDICATIONS. IT WAS FURTHER REPORTED THAT ON (B)(6) 2021, THE SUBJECT UNDERWENT ELECTIVE RIGHT TRANS CERVICAL CAROTID ARTERY REVASCULARIZATION TO TREAT THE EVENT.

    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 OCCURRED. THE SUBJECT WAS ON ASPIRIN MEDICATION PRIOR TO CONSENT AND SCREENING FOR THE STUDY. THE SUBJECT WAS UNSUITABLE FOR ORAL ANTICOAGULANT'S (OAC'S) DUE TO OTHER CLINICALLY RELEVANT ORGAN BLEEDING GASTROINTESTINAL LESIONS. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 20.3MM. AFTER THE IMPLANT THE SUBJECT WAS STARTED ON ASPIRIN AND CLOPIDOGREL. THE SUBJECT WAS DISCHARGED ON (B)(6) 2018. ON (B)(6) 2021, 911 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF DOUBLE VISION AND GAIT INSTABILITY. THE SUBJECT DENIED WEAKNESS, NUMBNESS, CHANGE IN SPEECH AND TRAUMA. AT THE TIME OF REPORTING, THE SUBJECT WAS NOT ON ANTICOAGULATION OR ANTIPLATELET MEDICATION. THE SUBJECT WAS STOPPED ON ELIQUIS FOR ATRIAL FIBRILLATION SINCE THE SUBJECT HAD ANEMIA OF UNCLEAR ORIGIN. THE SUBJECT WAS STARTED ON TISSUE PLASMINOGEN ACTIVATOR (TPA). ON (B)(6) 2021, A COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD WITHOUT CONTRAST WAS PERFORMED AND A CT SCAN ANGIOGRAPHY OF THE HEAD AND NECK INCLUDING MAXIMUM INTENSITY PROJECTION (MIP) RECONSTRUCTION WAS PERFORMED. UPON DISCUSSION WITH NEUROLOGIST THE SUBJECT WAS TRANSFERRED AND MONITORED IN THE INTENSIVE CARE UNIT. THE SUBJECT WAS RECOMMENDED TO FOLLOW UP WITH VASCULAR SURGERY, BUT THE SURGERY WAS DECLINED DUE TO STENOSIS <70% AND WAS ADVISED TO MANAGE MEDICALLY. ON (B)(6) 2021, AN X-RAY OF THE CHEST AND A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED. ON THE SAME DAY, AN MRI OF THE BRAIN WITHOUT INTRAVENOUS CONTRAST REVEALED NO ACUTE INFRACTION OR HEMORRHAGE. THE EVENT WAS CLASSIFIED AS ISCHEMIC STROKE. THE SUSPECTED CAUSE WAS CHRONIC CALCIFIC ATHEROSCLEROTIC PLAQUE. THE SUBJECT WAS RECOMMENDED TO FOLLOW UP AS AN OUTPATIENT FOR SCHEDULED NEUROLOGY AND CARDIOLOGY CONSULT. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED HOME ON ASPIRIN, CLOPIDOGREL AND OTHER MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185736 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371 0020597116 08714729838234

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| O