BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN FLX? PRO

    MDR report key: 24955499 · Received April 22, 2026

    Report

    Report Number
    2124215-2026-21755
    Event Type
    Death
    Date Received
    April 22, 2026
    Date of Event
    March 27, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004613
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC (BSC) CONCLUDES: DEVICE TECHNICAL ANALYSIS: THE WATCHMAN FLX? PRO REMAINS IMPLANTED; THEREFORE, RETURNED DEVICE ANALYSIS COULD NOT BE COMPLETED. DEVICE HISTORY RECORD REVIEW: A REVIEW WAS COMPLETED OF THE DEVICE HISTORY RECORDS (DHR) FOR THE WATCHMAN FLX? PRO, PART # M635WU60310 BATCH # 0036260972. THE DEVICE WAS PROCESSED THROUGH ALL NORMAL OPERATIONAL CONDITIONS AND PASSED ALL ACCEPTANCE ACTIVITIES. THE DHR REVIEW DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE EVENT. LABELING REVIEW: THERE WAS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELING. WATCHMAN FLX? PRO INSTRUCTIONS FOR USE (IFU) LISTS POTENTIAL COMPLICATIONS, RISKS AND ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THIS DEVICE WHICH INCLUDE CEREBRAL VASCULAR ACCIDENT (CVA), THROMBOSIS (HOSPITALIZATION, MEDICATION AND IMAGING REQUIRED) AND DEATH. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF CEREBRAL VASCULAR ACCIDENT (CVA), THROMBOSIS AND DEATH WERE DEFINED IN THE RISK DOCUMENTATION. THESE EVENT TYPES HAVE BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF NO PROBLEM DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 31MM WATCHMAN FLX PRO CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2025. THE PATIENT WAS DISCHARGED ON ELIQUIS 5 MG TWICE DAILY (BID) AND ASPIRIN 81MG DAILY. THE PATIENT HAD A PRIOR CEREBROVASCULAR ACCIDENT (CVA) BEFORE CLOSURE DEVICE IMPLANTATION. AT THE SIX (6) WEEK LAAC FOLLOW-UP VISIT ON (B)(6) 2025, ANTICOAGULATION WAS SWITCHED FROM ELIQUIS AND ASPIRIN TO CLOPIDOGREL 75MG DAILY WITH CONTINUED ASPIRIN 81MG. ON (B)(6) 2025, THE PATIENT WAS SEEN IN THE VASCULAR CLINIC FOR ANNUAL SURVEILLANCE OF CAROTID ARTERY STENOSIS, STATUS POST (S/P) RIGHT CAROTID ENDARTERECTOMY IN 2018. A POST-LAAC COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED ON (B)(6) 2025, SHOWED A WELL-SEATED 31MM CLOSURE DEVICE WITH A SMALL 7 X 5 MM THROMBUS ADHERENT TO THE CLOSURE DEVICE EDGE AND THERE WAS NO PERI-DEVICE LEAK. IT WAS RECOMMENDED THE PATIENT TO BE PLACED ON ELIQUIS FOR THREE (3) ADDITIONAL MONTHS WITH REPEAT IMAGING. THE PATIENT WAS EVALUATED BY PULMONOLOGY ON (B)(6) 2025, FOR A HISTORY OF GRANULOMATOUS LUNG NODULE, CAVITARY NODULES, AND ACTINOMYCES ON CULTURE, WITH INCREASED HEMOPTYSIS NOTED WHILE ON ANTIPLATELET THERAPY. AT A HEART FAILURE NURSE PRACTITIONER VISIT ON (B)(6) 2025, IT WAS NOTED THAT THE PATIENT HAD NOT RESTARTED ELIQUIS AND WAS STILL TAKING DUAL ANTIPLATELET THERAPY (DAPT) CLOPIDOGREL AND ASPIRIN. ELIQUIS WAS RESTARTED ON (B)(6) 2025, ALONG WITH ASPIRIN. A REPEAT CT ON (B)(6) 2025, SHOWED A WELL SEATED 31MM CLOSURE DEVICE WITH TWO PEDUNCULATED THROMBI MEASURING 8 X 6 MM AND 6 X 6 MM ADHERENT TO THE CLOSURE DEVICE FACE, WITH NO PERI-DEVICE LEAK. CONVERSION TO WARFARIN WAS RECOMMENDED, BUT THE PATIENT DAUGHTER DECLINED, AND THE PATIENT CONTINUED ON ELIQUIS AND ASPIRIN FOR AN ADDITIONAL THREE (3) MONTHS WITH PLANNED REPEAT IMAGING. THE PATIENT CANCELLED THE SIX (6) MONTH FOLLOW-UP APPOINTMENT ON (B)(6) 2025, AND THE SCHEDULED REPEAT CT ON (B)(6) 2026 WAS CANCELLED DUE TO PRESSURE WOUNDS ON THE BACK REQUIRING A WOUND VACUUM AND UNABLE TO LAY DOWN. ON (B)(6) 2026, THE PATIENT WAS FOUND AT HOME SEATED ON THE TOILET, TOO WEAK TO STAND. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL AND DIAGNOSED WITH A NEW SUBACUTE CVA. DOCUMENTATION NOTED THE NEED FOR DIRECT ORAL ANTICOAGULANT (DOAC), CLOSURE DEVICE CLOT AND THE PATIENT DAUGHTER REPORTED THE PATIENT WAS NOT CONSISTENT WITH MEDICATIONS, WHICH INCREASED THE RISK. THE PATIENT WAS DISCHARGED TO LONG-TERM CARE WITH HOSPICE ON (B)(6) 2026 AND PASSED AWAY ON (B)(6) 2026. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 31MM WATCHMAN FLX PRO CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2025. THE PATIENT WAS DISCHARGED ON ELIQUIS 5 MG TWICE DAILY (BID) AND ASPIRIN 81MG DAILY. THE PATIENT HAD A PRIOR CEREBROVASCULAR ACCIDENT (CVA) BEFORE CLOSURE DEVICE IMPLANTATION. AT THE SIX (6) WEEK LAAC FOLLOW-UP VISIT ON 2025, ANTICOAGULATION WAS SWITCHED FROM ELIQUIS AND ASPIRIN TO CLOPIDOGREL 75MG DAILY WITH CONTINUED ASPIRIN 81MG. ON (B)(6) 2025, THE PATIENT WAS SEEN IN THE VASCULAR CLINIC FOR ANNUAL SURVEILLANCE OF CAROTID ARTERY STENOSIS, STATUS POST (S/P) RIGHT CAROTID ENDARTERECTOMY IN 2018. A POST-LAAC COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED ON (B)(6) 2025, SHOWED A WELL-SEATED 31MM CLOSURE DEVICE WITH A SMALL 7X5 MM THROMBUS ADHERENT TO THE CLOSURE DEVICE EDGE AND THERE WAS NO PERI-DEVICE LEAK. IT WAS RECOMMENDED THE PATIENT TO BE PLACED ON ELIQUIS FOR THREE (3) ADDITIONAL MONTHS WITH REPEAT IMAGING. THE PATIENT WAS EVALUATED BY PULMONOLOGY ON (B)(6) 2025, FOR A HISTORY OF GRANULOMATOUS LUNG NODULE, CAVITARY NODULES, AND ACTINOMYCES ON CULTURE, WITH INCREASED HEMOPTYSIS NOTED WHILE ON ANTIPLATELET THERAPY. AT A HEART FAILURE NURSE PRACTITIONER VISIT ON (B)(6) 2025, IT WAS NOTED THAT THE PATIENT HAD NOT RESTARTED ELIQUIS AND WAS STILL TAKING DUAL ANTIPLATELET THERAPY (DAPT) CLOPIDOGREL AND ASPIRIN. ELIQUIS WAS RESTARTED ON (B)(6) 2025, ALONG WITH ASPIRIN. A REPEAT CT ON (B)(6) 2025, SHOWED A WELL SEATED 31MM CLOSURE DEVICE WITH TWO PEDUNCULATED THROMBI MEASURING 8X6MM AND 6X6MM ADHERENT TO THE CLOSURE DEVICE FACE, WITH NO PERI-DEVICE LEAK. CONVERSION TO WARFARIN WAS RECOMMENDED, BUT THE PATIENT DAUGHTER DECLINED, AND THE PATIENT CONTINUED ON ELIQUIS AND ASPIRIN FOR AN ADDITIONAL THREE (3) MONTHS WITH PLANNED REPEAT IMAGING. THE PATIENT CANCELLED THE SIX (6) MONTH FOLLOW-UP APPOINTMENT ON (B)(6) 2025, AND THE SCHEDULED REPEAT CT ON (B)(6) 2026 WAS CANCELLED DUE TO PRESSURE WOUNDS ON THE BACK REQUIRING A WOUND VACUUM AND UNABLE TO LAY DOWN. ON (B)(6) 2026, THE PATIENT WAS FOUND AT HOME SEATED ON THE TOILET, TOO WEAK TO STAND. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL AND DIAGNOSED WITH A NEW SUBACUTE CVA. DOCUMENTATION NOTED THE NEED FOR DIRECT ORAL ANTICOAGULANT (DOAC), CLOSURE DEVICE CLOT AND THE PATIENT DAUGHTER REPORTED THE PATIENT WAS NOT CONSISTENT WITH MEDICATIONS, WHICH INCREASED THE RISK. THE PATIENT WAS DISCHARGED TO LONG-TERM CARE WITH HOSPICE ON (B)(6) 2026 AND PASSED AWAY ON (B)(6) 2026. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470144 WATCHMAN FLX? PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60310 0036260972 00191506004613

    Patients

    Seq Age Sex Outcome Treatment
    1