BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN FLX? PRO

    MDR report key: 24546555 · Received March 9, 2026

    Report

    Report Number
    2124215-2026-12876
    Event Type
    Death
    Date Received
    March 9, 2026
    Date of Event
    February 16, 2026
    Report Date
    April 14, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004606
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2: OUTCOME OF DEATH, AND DEATH DATE ADDED. B5: INFORMATION ADDED. H1 TYPE OF REPORTABLE EVENT CHANGED FROM SERIOUS INJURY TO DEATH. H6 IMPACT CODE ADDED: DEATH.

    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 # M635WU60270, BATCH # 0036809715. 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 RESPIRATORY FAILURE, HYPOXIA, CEREBRAL VASCULAR ACCIDENT (CVA) (ENCEPHALOPATHY, WEAKNESS, SPEECH DISORDERS, MENTAL, EMOTIONAL OR BEHAVIORAL PROBLEM), VOMITING AND DEATH (VENTILATION, INTUBATION, HOSPITALIZATION, REHABILITATION, INTENSIVE CARE, IMAGING AND MEDICATION REQUIRED). RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF RESPIRATORY FAILURE, HYPOXIA, CEREBRAL VASCULAR ACCIDENT (CVA) (ENCEPHALOPATHY, WEAKNESS, SPEECH DISORDERS, MENTAL, EMOTIONAL OR BEHAVIORAL PROBLEM), VOMITING 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 KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    REPORTED VIA CLINICAL STUDY: IT WAS REPORTED THAT A CEREBROVASCULAR ACCIDENT (CVA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. APPROXIMATELY 175 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER WAKING WITH INABILITY TO TURN TO THE LEFT SIDE AND NEW LEFT-SIDED WEAKNESS. THE PATIENT WAS ALSO NOTED TO HAVE ALTERED MENTAL STATUS AND SLURRED SPEECH. DURING COMPUTED TOMOGRAPHY (CT) IMAGING, THE PATIENT'S NEUROLOGICAL CONDITION WORSENED WITH INABILITY TO FORM SENTENCES AND GARBLED SPEECH. DUE TO VOMITING AND INABILITY TO PROTECT THE AIRWAY, THE PATIENT WAS INTUBATED AND ADMITTED TO THE INTENSIVE CARE UNIT ON MECHANICAL VENTILATION. INITIAL CT IMAGING OF THE HEAD SHOWED NO ACUTE INTRACRANIAL ABNORMALITIES. TWO (2) DAYS LATER CODE STROKE WAS CALLED. CLINICAL EVALUATION NOTED ACUTE METABOLIC ENCEPHALOPATHY SECONDARY TO STROKE (POSTERIOR CIRCULATION STROKE), ACUTE RESPIRATORY FAILURE WITH HYPOXIA, AND PERSISTENT LEFT-SIDED WEAKNESS. THE PATIENT WAS INTUBATED, GIVEN INTRAVENOUS MEDICATIONS AND FLUIDS, SEDATION, NASOGASTRIC TUBE PLACEMENT, RESPIRATORY SUPPORT, ANTIBIOTICS, AND REHABILITATION THERAPIES. MULTIPLE DIAGNOSTIC TESTS WERE PERFORMED. DUE TO CONTINUED CLINICAL DECLINE, THE FAMILY AGREED TO TRANSITION THE PATIENT TO HOSPICE ON (B)(6) 2026. IT WAS FURTHER REPORTED THE PATIENT DIED ON (B)(6) 2026 WITH THE CAUSE OF DEATH BEING METABOLIC ENCEPHALOPATHY (ACUTE) FROM STROKE.

    Description of Event or Problem · 0

    REPORTED VIA CLINICAL STUDY: IT WAS REPORTED THAT A CEREBROVASCULAR ACCIDENT (CVA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. APPROXIMATELY 175 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER WAKING WITH INABILITY TO TURN TO THE LEFT SIDE AND NEW LEFT-SIDED WEAKNESS. THE PATIENT WAS ALSO NOTED TO HAVE ALTERED MENTAL STATUS AND SLURRED SPEECH. DURING COMPUTED TOMOGRAPHY (CT) IMAGING, THE PATIENT'S NEUROLOGICAL CONDITION WORSENED WITH INABILITY TO FORM SENTENCES AND GARBLED SPEECH. DUE TO VOMITING AND INABILITY TO PROTECT THE AIRWAY, THE PATIENT WAS INTUBATED AND ADMITTED TO THE INTENSIVE CARE UNIT ON MECHANICAL VENTILATION. INITIAL CT IMAGING OF THE HEAD SHOWED NO ACUTE INTRACRANIAL ABNORMALITIES. TWO (2) DAYS LATER, CODE STROKE WAS CALLED. CLINICAL EVALUATION NOTED ACUTE METABOLIC ENCEPHALOPATHY SECONDARY TO STROKE (POSTERIOR CIRCULATION STROKE), ACUTE RESPIRATORY FAILURE WITH HYPOXIA, AND PERSISTENT LEFT-SIDED WEAKNESS. THE PATIENT WAS INTUBATED, GIVEN INTRAVENOUS MEDICATIONS AND FLUIDS, SEDATION, NASOGASTRIC TUBE PLACEMENT, RESPIRATORY SUPPORT, ANTIBIOTICS, AND REHABILITATION THERAPIES. MULTIPLE DIAGNOSTIC TESTS WERE PERFORMED. DUE TO CONTINUED CLINICAL DECLINE, THE FAMILY AGREED TO TRANSITION THE PATIENT TO HOSPICE (B)(6) 2026. IT WAS FURTHER REPORTED THE PATIENT DIED ON (B)(6), 2026, WITH THE CAUSE OF DEATH BEING METABOLIC ENCEPHALOPATHY (ACUTE) FROM STROKE.

    Description of Event or Problem · 0

    REPORTED VIA CLINICAL STUDY. IT WAS REPORTED THAT A CEREBROVASCULAR ACCIDENT (CVA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. APPROXIMATELY 175 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER WAKING WITH INABILITY TO TURN TO THE LEFT SIDE AND NEW LEFT-SIDED WEAKNESS. THE PATIENT WAS ALSO NOTED TO HAVE ALTERED MENTAL STATUS AND SLURRED SPEECH. DURING COMPUTED TOMOGRAPHY (CT) IMAGING, THE PATIENT'S NEUROLOGICAL CONDITION WORSENED WITH INABILITY TO FORM SENTENCES AND GARBLED SPEECH. DUE TO VOMITING AND INABILITY TO PROTECT THE AIRWAY, THE PATIENT WAS INTUBATED AND ADMITTED TO THE INTENSIVE CARE UNIT ON MECHANICAL VENTILATION. INITIAL CT IMAGING OF THE HEAD SHOWED NO ACUTE INTRACRANIAL ABNORMALITIES. TWO (2) DAYS LATER CODE STROKE WAS CALLED. CLINICAL EVALUATION NOTED ACUTE METABOLIC ENCEPHALOPATHY SECONDARY TO STROKE (POSTERIOR CIRCULATION STROKE), ACUTE RESPIRATORY FAILURE WITH HYPOXIA, AND PERSISTENT LEFT-SIDED WEAKNESS. THE PATIENT WAS INTUBATED, GIVEN INTRAVENOUS MEDICATIONS AND FLUIDS, SEDATION, NASOGASTRIC TUBE PLACEMENT, RESPIRATORY SUPPORT, ANTIBIOTICS, AND REHABILITATION THERAPIES. MULTIPLE DIAGNOSTIC TESTS WERE PERFORMED. DUE TO CONTINUED CLINICAL DECLINE, THE FAMILY AGREED TO TRANSITION THE PATIENT TO HOSPICE ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20098 WATCHMAN FLX? PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60270 0036809715 00191506004606

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Hospitalization| D| R