BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 14685496 · Received June 14, 2022

    Report

    Report Number
    2134265-2022-06793
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    May 19, 2022
    Report Date
    November 21, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FACILITY NAME: (B)(6).

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6).

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6).

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE CHAMPION ATRIAL FIBRILLATION STUDY ON (B)(6) 2022 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THROMBOSIS OCCURRED. ON (B)(6) 2022, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 20MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A 16.0MM DIAMETER. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED ON ASPIRIN (80 MG) AND APIXABAN (10 MG). ON (B)(6) 2022, 86 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL REQUIRED 4-MONTH LAA IMAGING AND TEE ASSESSMENT REVEALED A COMPLETE SEAL WITH A LAMINAR, MOBILE THROMBUS WITH MAXIMUM AREA OF 0.1 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE. THROMBUS WAS NOTED AS A VERY SMALL MOBILE MASS ON THE WATCHMAN DEVICE PIN. HOWEVER, NO EVIDENCE OF THROMBUS IN THE LEFT ATRIUM, PERICARDIAL EFFUSION AND ATRIAL SEPTAL SHUNT WERE NOTED. IN RESPONSE TO EVENT, THE PATIENT WILL HAVE ANOTHER TRANSTHORACIC ECHOCARDIOGRAM (TTE) IN 4 WEEKS TO CONTROL. AT THE TIME OF EVENT, THE PATIENT WAS ON ASPIRIN. AT THE TIME OF REPORTING, THE EVENT WAS ONGOING.

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE CHAMPION ATRIAL FIBRILLATION STUDY ON (B)(6) 2022 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THROMBOSIS OCCURRED. ON (B)(6) 2022, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 20MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A 16.0MM DIAMETER. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED ON ASPIRIN (80 MG) AND APIXABAN (10 MG). ON (B)(6) 2022, 86 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL REQUIRED 4-MONTH LAA IMAGING AND TEE ASSESSMENT REVEALED A COMPLETE SEAL WITH A LAMINAR, MOBILE THROMBUS WITH MAXIMUM AREA OF 0.1 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE. THROMBUS WAS NOTED AS A VERY SMALL MOBILE MASS ON THE WATCHMAN DEVICE PIN. HOWEVER, NO EVIDENCE OF THROMBUS IN THE LEFT ATRIUM, PERICARDIAL EFFUSION AND ATRIAL SEPTAL SHUNT WERE NOTED. IN RESPONSE TO EVENT, THE PATIENT WILL HAVE ANOTHER TRANSTHORACIC ECHOCARDIOGRAM (TTE) IN 4 WEEKS TO CONTROL. AT THE TIME OF EVENT, THE PATIENT WAS ON ASPIRIN. AT THE TIME OF REPORTING, THE EVENT WAS ONGOING. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ON APIXABAN (10 MG) AND WAS STOPPED ON (B)(6) 2022. ASPIRIN (80 MG) WAS STARTED ONE DAY PRIOR TO IMPLANT AND WAS CONTINUED. NO ACTION WAS TAKEN TO TREAT THE LAMINAR THROMBUS.

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE CHAMPION ATRIAL FIBRILLATION STUDY ON 26JAN2022 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED, THAT THROMBOSIS OCCURRED. ON (B)(6) 2022, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. AND A 20MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A 16.0MM DIAMETER. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED ON ASPIRIN (80 MG) AND APIXABAN (10 MG). ON (B)(6) 2022, (B)(6) DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL REQUIRED 4-MONTH LAA IMAGING. AND TEE ASSESSMENT REVEALED, A COMPLETE SEAL WITH A LAMINAR, MOBILE THROMBUS WITH MAXIMUM AREA OF 0.1 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE. THROMBUS WAS NOTED, AS A VERY SMALL MOBILE MASS ON THE WATCHMAN DEVICE PIN. HOWEVER, NO EVIDENCE OF THROMBUS IN THE LEFT ATRIUM, PERICARDIAL EFFUSION AND ATRIAL SEPTAL SHUNT WERE NOTED. IN RESPONSE TO EVENT, THE PATIENT WILL HAVE ANOTHER TRANSTHORACIC ECHOCARDIOGRAM (TTE) IN (B)(6) WEEKS TO CONTROL. AT THE TIME OF EVENT, THE PATIENT WAS ON ASPIRIN. AT THE TIME OF REPORTING, THE EVENT WAS ONGOING. IT WAS FURTHER REPORTED, THAT THE PATIENT WAS ON APIXABAN (10 MG) AND WAS STOPPED ON (B)(6) 2022. ASPIRIN (80 MG) WAS STARTED ONE DAY, PRIOR TO IMPLANT. AND WAS CONTINUED. NO ACTION WAS TAKEN TO TREAT THE LAMINAR THROMBUS. IT WAS FURTHER REPORTED, THAT THE OUTCOME OF THE EVENT WAS CONSIDERED, TO BE RESOLVED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991010 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0025730302

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other