BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 16902590 · Received May 10, 2023

    Report

    Report Number
    2124215-2023-20384
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    April 20, 2023
    Report Date
    May 22, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ASAP TOO STUDY. IT WAS REPORTED AN ISCHEMIC CEREBRAL VASCULAR ACCIDENT OCCURRED. IN SEPTEMBER 2020, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). THE PATIENT WAS DISCHARGED ON (B)(6) 2020. IN (B)(6) 2023 939 DAYS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER EXPERIENCING AN ALTERED MENTAL STATUS AND METABOLIC ENCEPHALOPATHY. HEAD COMPUTED TOMOGRAPHY (CT) AND BRAIN MAGNETIC RESONANCE IMAGING (MRI) WERE PERFORMED. MRI IDENTIFIED A SMALL, SUB-ACUTE HEMORRHAGIC INFRACTION SUSPECTED IN THE POSTERIOR RIGHT OCCIPITAL PARIETAL REGION, MODERATE TO SEVERE AGE RELATED CHRONIC MICROVASCULAR ISCHEMIC CHANGES, AND SMALL FOCUS OF HEMOSIDERIN SUSPECTED IN THE RIGHT POSTERIOR PARIETAL TEMPORAL REGION. CT ANGIOGRAPHY THE OF HEAD AND NECK REVEALED FOCAL EDEMA IN THE PARAMEDIAN RIGHT PARIETAL LOBE MOST SUGGESTIVE OF RECENT INFARCT AND BILATERAL CAROTID BULB DISEASE DUE TO CALCIFIED PLAQUE BUT WITHOUT SIGNIFICANT STENOSIS. THE PATIENT WAS DIAGNOSED WITH ISCHEMIC STROKE WITH HEMORRHAGIC TRANSFORMATION AND DURATION OF FOCAL OR GLOBAL NEUROLOGICAL DEFICIT GREATER THAN TWENTY-FOUR (24) HOURS. THREE DAYS POST ADMITTANCE TO THE HOSPITAL A REPEAT HEAD CT WAS CONDUCTED WHICH REVEALED A SIMILAR APPEARANCE IN THE RIGHT POSTERIOR PARIETAL LOBE INFARCT. FOUR DAYS POST ADMITTANCE TO THE HOSPITAL THE PATIENT WAS PRESCRIBED CLOPIDOGREL. FIVE DAYS POST ADMITTANCE TO THE HOSPITAL, THE MENTAL STATUS OF THE PATIENT RETURNED TO BASELINE AND NO ADDITIONAL NEUROLOGICAL DEFICITS WERE OBSERVED. THE PATIENT WAS DISCHARGED FIVE DAYS POST ADMITTANCE TO THE HOSPITAL. IT WAS FURTHER REPORTED IN THAT IN (B)(6) 2023 960 DAYS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A TRANSIENT EPISODE OF DISORIENTATION, ALTERED BEHAVIOR, AND DELIRIUM ASSOCIATED WITH A POSSIBLE ACUTE CEREBROVASCULAR EVENT. THE RESULTS OF AN ELECTROENCEPHALOGRAM (EEG) WERE NEGATIVE FOR EVIDENCE OF EPILEPTIFORM ACTIVITY. THE PATIENT UNDERWENT A TRANSESOPHAGEAL ECHOCARDIOGRAM AND A COMPUTED TOMOGRAPHY SCAN WHICH REVEALED THE SUGGESTION OF NON HEMORRHAGIC ACUTE TO SUB ACUTE INFRACTION INVOLVING THE RIGHT PARIETAL LOBE. THE PATIENT WAS DIAGNOSED WITH DECOMPENSATED HEPATIC ENCEPHALOPATHY. THREE DAYS POST ADMITTANCE TO THE HOSPITAL THE PATIENT WAS DISCHARGED.

    Description of Event or Problem · 0

    ASAP TOO STUDY. IT WAS REPORTED AN ISCHEMIC CEREBRAL VASCULAR ACCIDENT OCCURRED. IN (B)(6) 2020, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). THE PATIENT WAS DISCHARGED ON (B)(6) 2020. IN (B)(6) 2023, 939 DAYS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER EXPERIENCING AN ALTERED MENTAL STATUS AND METABOLIC ENCEPHALOPATHY. HEAD COMPUTED TOMOGRAPHY (CT) AND BRAIN MAGNETIC RESONANCE IMAGING (MRI) WERE PERFORMED. MRI IDENTIFIED A SMALL, SUB-ACUTE HEMORRHAGIC INFRACTION SUSPECTED IN THE POSTERIOR RIGHT OCCIPITAL PARIETAL REGION, MODERATE TO SEVERE AGE RELATED CHRONIC MICROVASCULAR ISCHEMIC CHANGES, AND SMALL FOCUS OF HEMOSIDERIN SUSPECTED IN THE RIGHT POSTERIOR PARIETAL TEMPORAL REGION. CT ANGIOGRAPHY THE OF HEAD AND NECK REVEALED FOCAL EDEMA IN THE PARAMEDIAN RIGHT PARIETAL LOBE MOST SUGGESTIVE OF RECENT INFARCT AND BILATERAL CAROTID BULB DISEASE DUE TO CALCIFIED PLAQUE BUT WITHOUT SIGNIFICANT STENOSIS. THE PATIENT WAS DIAGNOSED WITH ISCHEMIC STROKE WITH HEMORRHAGIC TRANSFORMATION AND DURATION OF FOCAL OR GLOBAL NEUROLOGICAL DEFICIT GREATER THAN TWENTY-FOUR (24) HOURS. THREE DAYS POST ADMITTANCE TO THE HOSPITAL A REPEAT HEAD CT WAS CONDUCTED WHICH REVEALED A SIMILAR APPEARANCE IN THE RIGHT POSTERIOR PARIETAL LOBE INFARCT. FOUR DAYS POST ADMITTANCE TO THE HOSPITAL THE PATIENT WAS PRESCRIBED CLOPIDOGREL. FIVE DAYS POST ADMITTANCE TO THE HOSPITAL, THE MENTAL STATUS OF THE PATIENT RETURNED TO BASELINE AND NO ADDITIONAL NEUROLOGICAL DEFICITS WERE OBSERVED. THE PATIENT WAS DISCHARGED FIVE DAYS POST ADMITTANCE TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882240 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0025289076 08714729860518

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other| H