BEUDAMED
    FDA Adverse Event Death Summary report: Y

    WATCHMAN FLX?

    MDR report key: 22579676 · Received July 23, 2025

    Report

    Report Number
    2124215-2025-47584
    Event Type
    Death
    Date Received
    July 23, 2025
    Report Date
    July 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QUARTERLY REPORTING PERIOD: Q2 2025. AVERAGE TIME TO EVENT: 483 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 WATCHMAN FLX DAPT POST APPROVAL PLAN (WATCHMAN FLX-DAPT).

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 4 DEATH EVENTS FOR CEREBRAL VASCULAR ACCIDENT (CVA). 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. AGE RANGE: 48 TO 83 YEARS. PATIENT SEX: 2 FEMALES; 2 MALES. TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE WATCHMAN LAAC DEVICE REPORTED IN THE LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY (LAAO) REGISTRY, WATCHMAN FLX DAPT CLINICAL STUDY 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 THE SUMMARY REPORTING GUIDELINES. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. 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
    47160 WATCHMAN FLX? SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU50200 08714729860488

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown