BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 10144708 · Received June 11, 2020

    Report

    Report Number
    2134265-2020-07141
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    May 5, 2020
    Report Date
    November 7, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: UPDATED.

    Additional Manufacturer Narrative · 0

    B5: UPDATED TO CLARIFY 14MM LEAK WAS NOTICED ON (B)(6) 2022 NOT (B)(6) 2022.

    Description of Event or Problem · 0

    OPTION STUDY IT WAS REPORTED THE CLOSURE DEVICE DID NOT SEAL. ON (B)(6) 2020, THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. PRIOR TO THE PROCEDURE, THE PATIENT WAS ON RIVAROXABAN AND ASPIRIN. HEPARIN WAS ADMINISTERED AND THE PRE-PROCEDURE INTERNATIONAL NORMALIZED RATIO (INR) WAS 2.2. A 27MM WATCHMAN LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 90 MM. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ON (B)(6) 2020, THE PATIENT PRESENTED FOR A THREE MONTH FOLLOW UP VISIT. THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A LEFT VENTRICLE EJECTION FRACTION (LVEF) OF 60% AND LAA SEAL OF JET SIZE GREATER THAN 5MM AND THE LARGEST RESIDUAL JET AROUND THE CLOSURE DEVICE WAS 2.2 MM. IT WAS ALSO NOTED THERE WAS A PERICARDIAL EFFUSION OF 2 MM ADJACENT TO THE LEFT ATRIAL APPENDAGE AND POSTERIOR TO THE LEFT VENTRICLE. IT WAS FURTHER REPORTED THAT ON (B)(6) 2022, 941 DAYS POST INDEX PROCEDURE, TEE REVEALED 14 MM RESIDUAL FLOW BETWEEN LA (LEFT ATRIUM) AND LAA (LEFT ATRIAL APPENDAGE). THE TEE IMAGING PERFORMED ON (B)(6) 2022 REVEALED INCOMPLETE LAA SEAL WITH 14MM LARGEST RESIDUAL JET AROUND DEVICE. THE PATIENT WAS ON ASPIRIN AT THE TIME. ON (B)(6) 2023, THE PATIENT UNDERWENT A LEAK CLOSURE PROCEDURE TO TREAT THE LEAK.

    Description of Event or Problem · 0

    OPTION STUDY. IT WAS REPORTED THE CLOSURE DEVICE DID NOT SEAL. ON (B)(6) 2020, THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. PRIOR TO THE PROCEDURE, THE PATIENT WAS ON RIVAROXABAN AND ASPIRIN. HEPARIN WAS ADMINISTERED AND THE PRE-PROCEDURE INTERNATIONAL NORMALIZED RATIO (INR) WAS 2.2. A 27MM WATCHMAN LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 90 MM. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ON (B)(6) 2020, THE PATIENT PRESENTED FOR A THREE MONTH FOLLOW UP VISIT. THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A LEFT VENTRICLE EJECTION FRACTION (LVEF) OF 60% AND LAA SEAL OF JET SIZE GREATER THAN 5MM AND THE LARGEST RESIDUAL JET AROUND THE CLOSURE DEVICE WAS 2.2 MM. IT WAS ALSO NOTED THERE WAS A PERICARDIAL EFFUSION OF 2 MM ADJACENT TO THE LEFT ATRIAL APPENDAGE AND POSTERIOR TO THE LEFT VENTRICLE. IT WAS FURTHER REPORTED THAT ON (B)(6) 2022, 941 DAYS POST INDEX PROCEDURE, TEE REVEALED 14 MM RESIDUAL FLOW BETWEEN LA (LEFT ATRIUM) AND LAA (LEFT ATRIAL APPENDAGE). THE TEE IMAGING PERFORMED ON (B)(6) 2022 REVEALED INCOMPLETE LAA SEAL WITH 14MM LARGEST RESIDUAL JET AROUND DEVICE. THE PATIENT WAS ON ASPIRIN AT THE TIME. ON (B)(6) 2023, THE PATIENT UNDERWENT A LEAK CLOSURE PROCEDURE TO TREAT THE LEAK. IT WAS FURTHER REPORTED THAT THE 14MM LEAK WAS IDENTIFIED ON (B)(6) 2022, NOT (B)(6) 2022.

    Description of Event or Problem · 1

    (B)(6). IT WAS REPORTED THE CLOSURE DEVICE DID NOT SEAL. ON (B)(6) 2020, THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. PRIOR TO THE PROCEDURE, THE PATIENT WAS ON RIVAROXABAN AND ASPIRIN. HEPARIN WAS ADMINISTERED AND THE PRE-PROCEDURE INTERNATIONAL NORMALIZED RATIO (INR) WAS 2.2. A 27MM WATCHMAN LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 90 MM. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ON (B)(6) 2020, THE PATIENT PRESENTED FOR A THREE MONTH FOLLOW UP VISIT. THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A LEFT VENTRICLE EJECTION FRACTION (LVEF) OF 60% AND LAA SEAL OF JET SIZE GREATER THAN 5MM AND THE LARGEST RESIDUAL JET AROUND THE CLOSURE DEVICE WAS 2.2 MM. IT WAS ALSO NOTED THERE WAS A PERICARDIAL EFFUSION OF 2 MM ADJACENT TO THE LEFT ATRIAL APPENDAGE AND POSTERIOR TO THE LEFT VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606669 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10393 0024266020

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male