BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 11871486 · Received May 24, 2021

    Report

    Report Number
    2134265-2021-06659
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    April 30, 2021
    Report Date
    November 12, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: B5.

    Additional Manufacturer Narrative · 0

    UPDATED: B5.

    Description of Event or Problem · 0

    OPTION STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO THE PROCEDURE, PROPHYLACTIC ANTIBIOTICS WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 18.3 MM. THERE WAS NO EVIDENCE OF THROMBUS PRESENT ON THE ATRIAL FACING SURFACE OF THE WATCHMAN DEVICE POST PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. ON (B)(6) 2021, 79 DAYS POST PROCEDURE, DURING THE PROTOCOL SCHEDULED 3 MONTHS FOLLOW-UP VISIT, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 55%. A PEDUNCULATED MOBILE THROMBUS WITH A MAXIMUM AREA OF 0.6 CM2 WAS FOUND ON THE ATRIAL FACING SURFACE OF THE WATCHMAN DEVICE. THE PATIENT WAS TREATED WITH AN ADJUSTMENT IN ORAL MEDICATION. AT THE TIME OF REPORTING THE EVENT WAS CONSIDERED RECOVERING/RESOLVING. IT WAS FURTHER REPORTED THAT ON (B)(6) 2021 THE PATIENT WAS DISCHARGED ON ASPIRIN AND APIXABAN. AT THE TIME OF THE EVENT, APIXABAN WAS DISCONTINUED AND THE PATIENT WAS STARTED ON ENOXAPARIN; SUBCUTANEOUS ROUTE EVERY 12 HOURS. ON (B)(6) 2021, ENOXAPARIN WAS DISCONTINUED AND THE EVENT WAS CONSIDERED RESOLVED.

    Description of Event or Problem · 0

    OPTION STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO THE PROCEDURE, PROPHYLACTIC ANTIBIOTICS WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 18.3 MM. THERE WAS NO EVIDENCE OF THROMBUS PRESENT ON THE ATRIAL FACING SURFACE OF THE WATCHMAN DEVICE POST PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. ON (B)(6) 2021, 79 DAYS POST PROCEDURE, DURING THE PROTOCOL SCHEDULED 3 MONTHS FOLLOW-UP VISIT, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 55%. A PEDUNCULATED MOBILE THROMBUS WITH A MAXIMUM AREA OF 0.6 CM2 WAS FOUND ON THE ATRIAL FACING SURFACE OF THE WATCHMAN DEVICE. THE PATIENT WAS TREATED WITH AN ADJUSTMENT IN ORAL MEDICATION. AT THE TIME OF REPORTING THE EVENT WAS CONSIDERED RECOVERING/RESOLVING. IT WAS FURTHER REPORTED THAT ON (B)(6) 2021 THE PATIENT WAS DISCHARGED ON ASPIRIN AND APIXABAN. AT THE TIME OF THE EVENT, APIXABAN WAS DISCONTINUED AND THE PATIENT WAS STARTED ON ENOXAPARIN; SUBCUTANEOUS ROUTE EVERY 12 HOURS. ON (B)(6) 2021, ENOXAPARIN WAS DISCONTINUED AND THE EVENT WAS CONSIDERED RESOLVED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2021, THE EVENT WAS CONSIDERED RESOLVED.

    Description of Event or Problem · 1

    OPTION STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO THE PROCEDURE, PROPHYLACTIC ANTIBIOTICS WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 18.3 MM. THERE WAS NO EVIDENCE OF THROMBUS PRESENT ON THE ATRIAL FACING SURFACE OF THE WATCHMAN DEVICE POST PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. ON (B)(6) 2021, 79 DAYS POST PROCEDURE, DURING THE PROTOCOL SCHEDULED 3 MONTHS FOLLOW-UP VISIT, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 55%. A PEDUNCULATED MOBILE THROMBUS WITH A MAXIMUM AREA OF 0.6 CM2 WAS FOUND ON THE ATRIAL FACING SURFACE OF THE WATCHMAN DEVICE. THE PATIENT WAS TREATED WITH AN ADJUSTMENT IN ORAL MEDICATION. AT THE TIME OF REPORTING THE EVENT WAS CONSIDERED RECOVERING/RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766917 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0026166491 08714729860495

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other