BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 11572970 · Received March 25, 2021

    Report

    Report Number
    2134265-2021-03774
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    December 19, 2019
    Report Date
    March 25, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729838241
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ID - (B)(6).

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT OCCURRED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 22.2 MM. AFTER THE IMPLANT THE SUBJECT WAS STARTED ON ASPIRIN AND CLOPIDOGREL. THE SUBJECT WAS DISCHARGED ON (B)(6) 2019. ON (B)(6) C2019, 163 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS HOSPITALIZED FOR ACUTE RESPIRATORY FAILURE WITH HYPOXIA. THE SUBJECT WAS DIAGNOSED WITH HEART FAILURE AND TREATED WITH ORAL PREDNISONE. ON (B)(6) 2019, THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED. ON (B)(6) 2019, 171 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED VIA EMERGENCY MEDICAL SERVICES (EMS) WITH COMPLAINTS OF SHORTNESS OF BREATH THAT BEGAN A FEW HOURS PRIOR. THE SUBJECT ALSO COMPLAINED OF COUGH WITH YELLOW SPUTUM, NAUSEA, DIARRHEA AND NEAR EMESIS. PER EMS UPON ARRIVAL, THE SUBJECT WAS HYPOXIC WITH 74% OXYGEN SATURATION ON ROOM AIR BUT QUICKLY RETURNED TO 95% ON CPAP. THE SUBJECT HAD A FEVER OF 103 DEGREES. THE SUBJECT WAS HOSPITALIZED FOR FURTHER TREATMENT AND MANAGEMENT OF THE EVENT. A CT SCAN OF THE HEAD WAS PERFORMED THAT WAS SUSPICIOUS FOR CHRONIC RIGHT CEREBELLAR AND A NEW ACUTE VS SUBACUTE INFRACT OF LEFT FRONTAL LOBE. AN EEG RULED OUT SEIZURES. ON (B)(6) 2020, 175 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH STROKE OF UNKNOWN TYPE AND THE SUSPECTED CAUSE WAS UNKNOWN. AN MRI REVEALED A NEW RIGHT CEREBELLAR STROKE IN THE AREA OF THE OLD RIGHT CEREBELLAR STROKE. NO ACTION WAS TAKEN TO TREAT THE EVENT. ON (B)(6) 2019, THE SUBJECT HAD TWO EPISODES OF POLYMORPHIC VENTRICULAR TACHYCARDIA CARDIAC ARREST AND THE SUSPECTED CAUSE WAS VENTRICULAR FIBRILLATION. THE SUBJECT RECEIVED ELECTRICAL CARDIOVERSION (SHOCK), CPR AND ACHIEVED RETURN OF SPONTANEOUS CIRCULATION BOTH TIMES. THE SUBJECT WAS ALSO GIVEN AMIODARONE. CARDIAC CATH WAS NEGATIVE FOR CULPRIT LESION ON ANGIOGRAPHY. TRANSTHORACIC ECHO (TTE) REVEALED AN OVERALL LEFT VENTRICULAR EJECTION FRACTION OF 25-30%, SEVERELY DECREASED GLOBAL LEFT VENTRICULAR SYSTOLIC FUNCTION AND MILD TO MODERATE MITRAL VALVE REGURGITATION. THE TISSUE DOPPLER INDICATED ELEVATED LEFT VENTRICULAR END DIASTOLIC PRESSURE. ON (B)(6) 2019, A CT HEAD / BRAIN WITHOUT CONTRAST REVEALED A NEW ILL-DEFINED AREA OF DECREASED ATTENUATION WITH DIMINISHED GREY-WHITE DIFFERENTIATION IN THE INFERIOR ASPECT OF THE LEFT FRONTAL LOBE, SUSPICIOUS FOR ACUTE VERSUS SUBACUTE ISCHEMIC INFARCT. ON (B)(6) 2019, THE ABNORMAL EEG REVEALED A MODERATE DEGREE OF CEREBRAL DYSFUNCTION CONSISTENT WITH A METABOLIC, TOXIC OR HYPOXIC ENCEPHALOPATHY. ON (B)(6) 2019, THE SUBJECT WAS DIAGNOSED WITH PULMONARY ALVEOLAR HEMORRHAGE. ON (B)(6) 2019 THE SUBJECT WAS NOTED WITH PULMONARY INFILTRATES. NO ACTION WAS TAKEN TO TREAT THE EVENT. OVER THE NEXT COUPLE OF HOURS, THE SUBJECT DEVELOPED A FEVER WITH INCREASED PROCALCITONIN LEVELS TO 2.13. AS A RESULT OF POOR PROGNOSIS, IT WAS DECIDED TO PROVIDE PALLIATIVE CARE AND TO WITHDRAW ALL OTHER MEASURES. THE SUBJECT WAS EXTUBATED. ON (B)(6) 2019, 181 DAYS POST ENROLLMENT, THE SUBJECT DIED. AS PER THE DEATH CERTIFICATE DATED (B)(6) 2019, THE IMMEDIATE CAUSE OF DEATH WAS HEART FAILURE AND THE UNDERLYING CAUSES WERE PULMONARY EDEMA, GLOBAL SYSTOLIC DYSFUNCTION AND VENTRICULAR ARRHYTHMIAS. OTHER SIGNIFICANT CONDITION CONTRIBUTING TO DEATH WAS ACUTE KIDNEY INJURY, PER DEATH CERTIFICATE. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469627 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371 0022786551 08714729838241

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other