BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 16993456 · Received May 24, 2023

    Report

    Report Number
    2124215-2023-25169
    Event Type
    Injury
    Date Received
    May 24, 2023
    Date of Event
    May 12, 2023
    Report Date
    November 7, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2: DOB ADDED.

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL EVENT INFORMATION ADDED

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE CHAMPION-AF STUDY ON (B)(6) 2022 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THROMBOSIS OCCURRED. ON (B)(6) 2023, THE A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED WITH SUCCESSFUL PLACEMENT OF A 31 MM WATCHMAN FLX DEVICE WITH COMPLETE SEAL AND DEPLOYED DEVICE DIAMETER OF 23.7 MM. THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN 81MG/DAY AND CLOPIDOGREL 75MG/DAY. ON (B)(6) 2023, 101 DAYS POST-IMPLANT PROCEDURE, FOUR (4)-MONTH FOLLOW-UP AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED ESTIMATED LEFT VENTRICULAR EJECTION FRACTION OF 55.0 % AND COMPLETE LAA SEAL WITH EVIDENCE OF PEDUNCULATED, MOBILE THROMBUS OF 0.135 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE. IN RESPONSE TO THE EVENT, THE PATIENT WAS STARTED ON WARFARIN 5MG.

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE CHAMPION-AF STUDY ON (B)(6) 2022 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THROMBOSIS OCCURRED. ON (B)(6) 2023, THE A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED WITH SUCCESSFUL PLACEMENT OF A 31 MM WATCHMAN FLX DEVICE WITH COMPLETE SEAL AND DEPLOYED DEVICE DIAMETER OF 23.7 MM. THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN 81MG/DAY AND CLOPIDOGREL 75MG/DAY. ON (B)(6) 2023, 101 DAYS POST-IMPLANT PROCEDURE, FOUR (4)-MONTH FOLLOW-UP AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED ESTIMATED LEFT VENTRICULAR EJECTION FRACTION OF 55.0 % AND COMPLETE LAA SEAL WITH EVIDENCE OF PEDUNCULATED, MOBILE THROMBUS OF 0.135 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE. IN RESPONSE TO THE EVENT, THE PATIENT WAS STARTED ON WARFARIN 5MG.

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE CHAMPION-AF STUDY ON (B)(6) 2022 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THROMBOSIS OCCURRED. ON (B)(6) 2023, THE A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED WITH SUCCESSFUL PLACEMENT OF A 31 MM WATCHMAN FLX DEVICE WITH COMPLETE SEAL AND DEPLOYED DEVICE DIAMETER OF 23.7 MM. THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN 81MG/DAY AND CLOPIDOGREL 75MG/DAY. ON (B)(6) 2023, 101 DAYS POST-IMPLANT PROCEDURE, FOUR (4)-MONTH FOLLOW-UP AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED ESTIMATED LEFT VENTRICULAR EJECTION FRACTION OF 55.0 % AND COMPLETE LAA SEAL WITH EVIDENCE OF PEDUNCULATED, MOBILE THROMBUS OF 0.135 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE. IN RESPONSE TO THE EVENT, THE PATIENT WAS STARTED ON WARFARIN 5MG. IT WAS FURTHER REPORTED THAT DURING AN UNSCHEDULED VISIT ON (B)(6) 2023, A TEE WAS PERFORMED AND REVEALED ESTIMATED LEFT VENTRICULAR FRACTION OF 55.0 % AND COMPLETE LAA SEAL WITH NO EVIDENCE OF THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897817 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0029966353 08714729860518

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other