BEUDAMED
    FDA Adverse Event Death Summary report: Y

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 18525222 · Received January 17, 2024

    Report

    Report Number
    2134265-2023-00159
    Event Type
    Death
    Date Received
    January 17, 2024
    Report Date
    January 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN RESPONSE TO AN FDA REQUEST DATED 14 DECEMBER 2023 TO PROVIDE CERTAIN MISSING INFORMATION FROM THE PREVIOUS REPORT, INCLUDING THE SUMMARY REPORT CHECKBOX, THE FDA EXEMPTION NUMBER, AND THE REGISTRY NAME. QUARTERLY REPORTING PERIOD: Q2 2021. AVERAGE TIME TO EVENT: 0 DAYS. DEVICE EVALUATION: UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, ANONYMIZED DATA WAS PROVIDED. NO PRODUCTS WERE RETURNED AS PART OF THE REGISTRY. IT CANNOT BE DETERMINED IF THESE EVENTS HAVE BEEN PREVIOUSLY REPORTED OR IF THE DEVICES WERE RETURNED FOR ANALYSIS AS PART OF A PREVIOUSLY REPORTED SPONTANEOUS COMPLAINT. HOWEVER, THE EVENTS REPORTED WERE ANTICIPATED IN NATURE AS DEFINED BY THE "POTENTIAL ADVERSE EVENTS" LIST IN THE FDA-APPROVED INSTRUCTIONS FOR USE (IFU). REGISTRY NAME: WATCHMAN FLX DEVICE SURVEILLANCE POST APPROVAL ANALYSIS PLAN (WATCHMAN FLX-SURPASS).

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 1 DEATH EVENT FOR CARDIAC TAMPONADE. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE ACC WATCHMAN SURPASS REGISTRY TO ASSESS LONG-TERM SAFETY AND EFFECTIVENESS OUTCOMES ASSOCIATED WITH THE USE AND IMPLANTATION OF THE WATCHMAN FLX LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE WITH DELIVERY SYSTEM IN A ROUTINE CLINICAL SETTING. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT; BUT ARE CAPTURED SEPARATELY UNDER THE TERMS OF FDA SUMMARY REPORTING GUIDELINES. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED AS A SPONTANEOUS COMPLAINT. THE REGISTRY DOES NOT PROVIDE A CAUSALITY RELATIONSHIP FOR EACH REPORTED EVENT TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601966 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown