BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 12149627 · Received July 12, 2021

    Report

    Report Number
    2134265-2021-08703
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    June 18, 2021
    Report Date
    October 27, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: B5, B7.

    Description of Event or Problem · 0

    OPTION STUDY: IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO THE INDEX PROCEDURE ASPIRIN WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 21.6 MM. AFTER THE IMPLANT THE PATIENT WAS CONTINUED ON ASPIRIN AND RIVAROXABAN. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED. ON (B)(6) 2021, 98 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR THE 3-MONTH FOLLOW-UP VISIT. THE TRANSESOPHAGEAL ECHO (TEE) REVEALED A CLOT ON THE WATCHMAN FLX DEVICE. THE PATIENT WAS STARTED ON ELIQUIS AND XARELTO WAS STOPPED. THE PATIENT WAS SCHEDULED FOR TEE FOLLOW-UP IN ANOTHER 3-MONTHS. THE EVENT IS CONSIDERED TO BE ONGOING. IT WAS FURTHER REPORTED THAT A 0.5 CM2 MOBILE, PEDUNCULATED THROMBUS ON THE ATRIAL FACING SURFACE OF THE WATCHMAN DEVICE WAS NOTED.

    Description of Event or Problem · 0

    OPTION STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO THE INDEX PROCEDURE ASPIRIN WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 21.6 MM. AFTER THE IMPLANT THE PATIENT WAS CONTINUED ON ASPIRIN AND RIVAROXABAN. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED. ON (B)(6) 2021, 98 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR THE 3-MONTH FOLLOW-UP VISIT. THE TRANSESOPHAGEAL ECHO (TEE) REVEALED A CLOT ON THE WATCHMAN FLX DEVICE. THE PATIENT WAS STARTED ON ELIQUIS AND XARELTO WAS STOPPED. THE PATIENT WAS SCHEDULED FOR TEE FOLLOW-UP IN ANOTHER 3-MONTHS. THE EVENT IS CONSIDERED TO BE ONGOING. IT WAS FURTHER REPORTED THAT ON (B)(6) 2021 THE TEE REVEALED A 0.5 CM2 MOBILE, PEDUNCULATED THROMBUS ON THE ATRIAL FACING SURFACE OF THE WATCHMAN DEVICE. IT WAS FURTHER REPORTED THAT THERE WAS NO EVIDENCE OF THROMBUS PRESENT ON THE LEFT ATRIUM, POST INDEX PROCEDURE. ON (B)(6) 2021, TEE REVEALED A WELL-POSITIONED DEVICE. THE PATIENT WAS ON ASPIRIN AND RIVAROXABAN AT THE TIME OF THE EVENT. RIVAROXABAN WAS DISCONTINUED AND THE PATIENT WAS INITIATED ON ELIQUIS FOR 3 MONTHS. ASPIRIN WAS CONTINUED. ON (B)(6) 2021, FOLLOW-UP TEE REVEALED NO EVIDENCE OF THROMBUS OR LEAK AROUND THE WATCHMAN DEVICE.

    Description of Event or Problem · 1

    OPTION STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO THE INDEX PROCEDURE ASPIRIN WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 21.6 MM. AFTER THE IMPLANT THE PATIENT WAS CONTINUED ON ASPIRIN AND RIVAROXABAN. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED. ON (B)(6) 2021, 98 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR THE 3-MONTH FOLLOW-UP VISIT. THE TRANSESOPHAGEAL ECHO (TEE) REVEALED A CLOT ON THE WATCHMAN FLX DEVICE. THE PATIENT WAS STARTED ON ELIQUIS AND XARELTO WAS STOPPED. THE PATIENT WAS SCHEDULED FOR TEE FOLLOW-UP IN ANOTHER 3-MONTHS. THE EVENT IS CONSIDERED TO BE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046239 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0026385912 08714729860501

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other