BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 13387308 · Received January 28, 2022

    Report

    Report Number
    2134265-2022-00696
    Event Type
    Injury
    Date Received
    January 28, 2022
    Date of Event
    October 25, 2021
    Report Date
    February 23, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) STUDY. IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 35MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS) WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 28 MM. PRIOR TO THE INDEX PROCEDURE ON (B)(6) 2020, THE PATIENT WAS TAKING DABIGATRAN AND ASPIRIN. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED. ON (B)(6) 2021, 223 DAYS POST PROCEDURE, THE PATIENT PRESENTED WITH A STROKE AND WAS HOSPITALIZED. AN ISCHEMIC STROKE WAS DIAGNOSED VIA COMPUTED TOMOGRAPHY SCAN, ULTRASOUND, AND X-RAY. INTRAVENOUS MEDICATIONS WERE ADMINISTERED TO RESOLVE THE EVENT AND THE PATIENT WAS DISCHARGED 11 DAYS AFTER ADMITTANCE TO THE HOSPITAL.

    Description of Event or Problem · 0

    OPTION STUDY. IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 35MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS) WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 28 MM. PRIOR TO THE INDEX PROCEDURE ON (B)(6) 2020, THE PATIENT WAS TAKING DABIGATRAN AND ASPIRIN. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED. ON (B)(6) 2021, 223 DAYS POST PROCEDURE, THE PATIENT PRESENTED WITH A STROKE AND WAS HOSPITALIZED. AN ISCHEMIC STROKE WAS DIAGNOSED VIA COMPUTED TOMOGRAPHY SCAN, ULTRASOUND, AND X-RAY. INTRAVENOUS MEDICATIONS WERE ADMINISTERED TO RESOLVE THE EVENT AND THE PATIENT WAS DISCHARGED 11 DAYS AFTER ADMITTANCE TO THE HOSPITAL. IT WAS ADDITIONALLY REPORTED THAT 223 DAYS POST INDEX PROCEDURE ON (B)(6) 2021, THE PATIENT PRESENTED AT THE EMERGENCY DEPARTMENT WITH NUMBNESS OF THE LEFT UPPER EXTREMITY AND APHASIA WITH A REMITTING TREND. THE PATIENT WAS HOSPITALIZED. DURING A NEUROLOGICAL PHYSICAL EXAMINATION MODERATE PARESIS AND HYPESTHESIA OF THE LEFT UPPER EXTREMITY WAS NOTED. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD WITHOUT CONTRAST SHOWED NO RECENT VASOGENIC ISCHEMIC LESIONS OR TRACES OF EXTRAVASATED BLOOD. A CT ANGIOGRAPHY OF THE HEAD AND NECK REVEALED A SUSPECTED EMBOLUS OF THE CENTRAL NERVOUS SYSTEM VESSELS AND RECENT PARESIS OF THE LEFT UPPER EXTREMITY. THE OBSERVED ARTERIES OF THE UPPER MEDIASTINUM, THE CERVICAL REGION, AND THE INTERCRANIAL REGION WERE NORMAL WITH NO SIGNIFICANT STENOSIS OR OCCLUSION. THE PATIENT WAS TRANSFERRED TO THE NEUROLOGY DEPARTMENT FOR FURTHER TREATMENT AND EVALUATION. THE PATIENT RECEIVED ACTILYSE, A THROMBOLYTIC MEDICATION, INTRAVENOUSLY. ONE DAY AFTER ADMITTANCE TO THE HOSPITAL, THE PATIENT UNDERWENT ANOTHER HEAD CT WHICH REVEALED A NORMAL PICTURE OF THE CORTEX AND SUBCORTICAL STRUCTURES. 10 DAYS AFTER ADMITTANCE TO THE HOSPITAL, DOPPLER ULTRASOUND OF THE NECK SHOWED THE CAROTID ARTERIES WERE NOT OCCLUDED, ABSENCE OF SIGNIFICANT ATHEROSCLEROTIC LESIONS, AND NORMAL FLOW WITHIN THE ARTERIES. ON (B)(6) 2021 THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED WITH A PRESCRIPTION FOR PRADAXA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1641871 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0026284567

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other