BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 12773343 · Received November 8, 2021

    Report

    Report Number
    2134265-2021-14017
    Event Type
    Injury
    Date Received
    November 8, 2021
    Date of Event
    September 9, 2021
    Report Date
    November 22, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: DESCRIBE EVENT OR PROBLEM: UPDATED.

    Description of Event or Problem · 0

    (B)(6) STUDY. IT WAS REPORTED THE CLOSURE DEVICE DID NOT SEAL. THE PATIENT WAS ENROLLED INTO (B)(6) STUDY ON (B)(6) 2021 AND THE INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2021. THAT SAME DAY, THE PATIENT UNDERWENT AF ABLATION USING PULMONARY VEIN ISOLATION BY RF-POINT BY POINT METHOD. A 35 MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED SUCCESSFULLY WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 29 MM. PRIOR TO PROCEDURE, THE PATIENT WAS ON ASPIRIN AND AFTER THE IMPLANT WAS CONTINUED ON THE SAME. THAT SAME DAY, THE PATIENT WAS DISCHARGED. ON (B)(6) 2021, 108 DAYS POST INDEX PROCEDURE, DURING THE PROTOCOL SCHEDULED 3-MONTH FOLLOW UP VISIT, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED AN INCOMPLETE LAA SEAL WITH JET SIZE OF GREATER THAN 5 MM.

    Description of Event or Problem · 0

    OPTION STUDY. IT WAS REPORTED THE CLOSURE DEVICE DID NOT SEAL. THE PATIENT WAS ENROLLED INTO OPTION STUDY ON (B)(6) 2021 AND THE INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2021. THAT SAME DAY, THE PATIENT UNDERWENT AF ABLATION USING PULMONARY VEIN ISOLATION BY RF-POINT BY POINT METHOD. A 35 MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED SUCCESSFULLY WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 29 MM. PRIOR TO PROCEDURE, THE PATIENT WAS ON ASPIRIN AND AFTER THE IMPLANT WAS CONTINUED ON THE SAME. THAT SAME DAY, THE PATIENT WAS DISCHARGED. ON (B)(6) 2021, 108 DAYS POST INDEX PROCEDURE, DURING THE PROTOCOL SCHEDULED 3-MONTH FOLLOW UP VISIT, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED AN INCOMPLETE LAA SEAL WITH JET SIZE OF GREATER THAN 5 MM. IT WAS FURTHER REPORTED THAT ON (B)(6) 2021, 108 DAYS POST INDEX PROCEDURE, THE SIZE OF LARGEST RESIDUAL JET AROUND DEVICE WAS 2 MM, NOT AS PREVIOUSLY REPORTED AS GREATER THAN 5MM. THE EVENT HAS BEEN WITHDRAWN FOR THIS REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672695 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0026975175 08714729860525

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other