BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX? PRO

    MDR report key: 24471014 · Received February 27, 2026

    Report

    Report Number
    2124215-2026-11051
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    January 30, 2026
    Report Date
    April 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004590
    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 # M635WU60240 BATCH # 0037260350. 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) (SKULL FRACTURE, VERTEBRAL FRACTURE, DYSPHASIA) (HOSPITALIZATION, IMAGING REQUIRED, DISABILITY, REHABILITATION). RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF CEREBRAL VASCULAR ACCIDENT (CVA) (SKULL FRACTURE, VERTEBRAL FRACTURE, DYSPHASIA) WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS 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 KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STROKE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 24MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. THREE (3) MONTHS POST-IMPLANT THE PATIENT EXPERIENCED A STROKE WHILE AT HOME AND WAS FOUND ON THE FLOOR WITH A FACE FRACTURE AND C4 SPINAL DISPLACEMENT. THE PATIENT WAS TAKEN TO A HOSPITAL AND HAD HEAD AND CHEST COMPUTED TOMOGRAPHY (CT). THE CHEST CT SHOWED THE CLOSURE DEVICE DID NOT HAVE ANY LEAK OR CLOT. THE PATIENT WAS PLACED ON PLAVIX AND ASPIRIN POST-IMPLANT DUE TO THEIR HISTORY OF SUBARACHNOID HEMORRHAGE (PRIOR TO WATCHMAN IMPLANT). THE PATIENT IS CURRENTLY AT A STROKE REHABILITATION FACILITY WITH HEALING FACE AND SPINAL FRACTURES AND SPEECH ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STROKE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 24MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. THREE (3) MONTHS POST-IMPLANT THE PATIENT EXPERIENCED A STROKE WHILE AT HOME AND WAS FOUND ON THE FLOOR WITH A FACE FRACTURE AND C4 SPINAL DISPLACEMENT. THE PATIENT WAS TAKEN TO A HOSPITAL AND HAD HEAD AND CHEST COMPUTED TOMOGRAPHY (CT). THE CHEST CT SHOWED THE CLOSURE DEVICE DID NOT HAVE ANY LEAK OR CLOT. THE PATIENT WAS PLACED ON PLAVIX AND ASPIRIN POST-IMPLANT DUE TO THEIR HISTORY OF SUBARACHNOID HEMORRHAGE (PRIOR TO WATCHMAN IMPLANT). THE PATIENT IS CURRENTLY AT A STROKE REHABILITATION FACILITY WITH HEALING FACE AND SPINAL FRACTURES AND SPEECH ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348601 WATCHMAN FLX? PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60240 0037260350 00191506004590

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Hospitalization| S