BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN FLX? PRO

    MDR report key: 24781872 · Received April 3, 2026

    Report

    Report Number
    2124215-2026-18338
    Event Type
    Death
    Date Received
    April 3, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004606
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT - AWARE DATE USED AS EVENT DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT - AWARE DATE USED AS EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A DEVICE RELATED THROMBUS. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. THE PATIENT CAME INTO THE HOSPITAL FOR ANOTHER PROCEDURE AND HAD A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING PROCEDURE PERFORMED. THE IMAGING SHOWED THAT THERE WAS A DEVICE RELATED THROMBUS PRESENT ON THE FACE OF THE CLOSURE DEVICE. THE PHYSICIAN PLACED THE PATIENT ON A FULL DOSE OF ELIQUIS IN RESPONSE TO THIS EVENT. THERE WERE NO OTHER COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. IT WAS FURTHER REPORTED THAT THE PATIENT SUBSEQUENTLY EXPERIENCED VENTRICULAR TACHYCARDIA (VT) AND WAS PRESENTED WITH TWO TREATMENT OPTIONS: A VT ABLATION ATTEMPT OR HOSPICE CARE. PER THE TREATING PHYSICIAN, THE PATIENT WAS INFORMED THAT VT ABLATION CARRIED AN ESTIMATED 50/50 RISK OF STROKE. MULTIPLE SPECIALTIES WERE CONSULTED, INCLUDING CARDIOLOGY, NEUROLOGY, AND CARDIOTHORACIC (CT) SURGERY. CT SURGERY DECLINED SURGICAL INTERVENTION TO REMOVE THE THROMBUS AND/OR EXCISE THE LAA. PRIOR TO VT ABLATION, THE THROMBUS WAS NOT VISUALIZED USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) DUE TO POOR IMAGE QUALITY; HOWEVER, THE CARE TEAM WAS AWARE OF THE KNOWN LARGE CLOT ON THE DEVICE. THE VT ABLATION WAS REPORTED AS SUCCESSFUL. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT REVERTED TO VT AND REQUIRED CARDIOVERSION. POST-PROCEDURE, THE PATIENT WAS DIFFICULT TO WAKE FROM MONITORED ANESTHESIA CARE (MAC) AND WAS UNABLE TO FOLLOW SIMPLE COMMANDS, INCLUDING SQUEEZING THE ANESTHESIOLOGIST HAND. NEUROLOGY WAS CALLED TO THE PROCEDURE ROOM, AND THE PATIENT WAS MONITORED FOR SEVERAL HOURS BY ANESTHESIA, CARDIOLOGY, ELECTROPHYSIOLOGY, AND NEUROLOGY TEAMS BEFORE BEING TRANSFERRED OUT OF THE PROCEDURE ROOM. IT WAS NOTED THAT NO CEREBRAL PROTECTION DEVICE OR FILTER WIRE (E.G., SENTINEL DEVICE) WAS USED DURING THE VT ABLATION, PER THE ELECTROPHYSIOLOGY FELLOW WHO WAS SCRUBBED IN FOR THE VT ABLATION. IT WAS NOT SPECIFIED WHERE THE PATIENT WAS TRANSFERRED FOLLOWING THE PROCEDURE, WHETHER NEUROIMAGING (CT OR MRI) WAS PERFORMED, OR WHERE THE PATIENT ULTIMATELY DIED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A DEVICE RELATED THROMBUS. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. THE PATIENT CAME INTO THE HOSPITAL FOR ANOTHER PROCEDURE AND HAD A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING PROCEDURE PERFORMED. THE IMAGING SHOWED THAT THERE WAS A DEVICE RELATED THROMBUS PRESENT ON THE FACE OF THE CLOSURE DEVICE. THE PHYSICIAN PLACED THE PATIENT ON A FULL DOSE OF ELIQUIS IN RESPONSE TO THIS EVENT. THERE WERE NO OTHER COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125037 WATCHMAN FLX? PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60270 00191506004606

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| O| H