BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN FLX? PRO

    MDR report key: 25220434 · Received May 19, 2026

    Report

    Report Number
    2124215-2026-26940
    Event Type
    Death
    Date Received
    May 19, 2026
    Date of Event
    November 10, 2025
    Report Date
    May 19, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004606
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2 DATE OF DEATH: ESTIMATED AS 11/10/2025 AS THE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS NOVEMBER 10, 2025. B3: AWARE DATE ESTIMATED AS 11/10/2025 AS THE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS NOVEMBER 10, 2025. D4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LITERATURE CITATION: PALATNIC L, MANION C, ZLOTNICK DM. PERCUTANEOUS DEBULKING OF LEFT ATRIAL APPENDAGE OCCLUSION DEVICE-ASSOCIATED THROMBI AND VEGETATION. JACC CASE REP. 2026 MAR 11;31(10):106540. DOI: 10.1016/J.JACCAS.2025.106540. EPUB 2026 JAN 14. PMID: 41532920; PMCID: PMC13002503.

    Description of Event or Problem · 0

    REPORTED VIA LITERATURE ARTICLE. IT WAS REPORTED THAT DEATH OCCURRED. A 79-YEAR-OLD MAN WITH 27MM WATCHMAN FLX PRO DEVICE IMPLANTED 4 MONTHS PRIOR, WAS ADMITTED TO THE MEDICAL INTENSIVE CARE UNIT GIVEN SEPTIC SHOCK SECONDARY TO METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS ENDOCARDITIS. THE PATIENT HOSPITAL COURSE WAS FURTHER COMPLICATED BY ACUTE HYPOXIC RESPIRATORY FAILURE AND ACUTE RENAL FAILURE REQUIRING HEMODIALYSIS. TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED A LEFT VENTRICULAR EJECTION FRACTION OF 20 TO 25 PERCENT AND MILDLY REDUCED RIGHT VENTRICULAR SYSTOLIC FUNCTION. OWING TO REFRACTORY SHOCK IN THE SETTING OF PERSISTENT BACTEREMIA, A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS OBTAINED, WHICH REVEALED A 0.6 X 0.6CM, GLOBULAR SHAPED, PEDUNCULATED, MOBILE ECHODENSITY SEEN IN ASSOCIATION WITH THE LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) CLOSURE DEVICE. A MULTIDISCIPLINARY HEART TEAM WAS CONSULTED FOR EVALUATION, AND THE PATIENT WAS DEEMED TOO HIGH RISK FOR CARDIAC SURGERY. THE DECISION WAS MADE TO PROCEED WITH NON-BOSTON SCIENTIFIC (BSC) ANGIOVAC DEBULKING ALONG WITH INTRAVENOUS ANTIBIOTIC THERAPY. THE PATIENT WAS BROUGHT TO THE CARDIAC CATHETERIZATION LABORATORY, AND BILATERAL FEMORAL VENOUS ACCESS WAS OBTAINED FOR THE NON-BSC ANGIOVAC SYSTEM 18-F REINFUSION CATHETER IN THE LEFT COMMON FEMORAL VEIN AND NON-BSC 26-F GORE DRYSEAL SHEATH IN THE RIGHT COMMON FEMORAL VEIN. ACCESS WAS ALSO OBTAINED IN THE RIGHT RADIAL ARTERY FOR PLACEMENT OF A SENTINEL CEREBRAL PROTECTION DEVICE. THE AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEADS WERE THEN EXTRACTED BY THE SURGICAL TEAM. AFTER ANTICOAGULATION WITH HEPARIN, A TRANSSEPTAL PUNCTURE WAS PERFORMED UNDER TEE GUIDANCE WITH THE BAYLIS SYSTEM FOLLOWED BY PLACEMENT OF AN AMPLATZ WIRE IN THE LEFT SUPERIOR PULMONARY VEIN. THE ATRIAL SEPTOSTOMY WAS DILATED WITH A 12 X 40MM BALLOON. THE NON-BSC ANGIOVAC C180 CANNULA WAS ADVANCED INTO THE LEFT ATRIUM, AND DEBULKING OF THE CLOSURE DEVICE WAS PERFORMED, WITH COMPLETE REMOVAL OF THE MOBILE COMPONENT. THE NON-BSC ANGIOVAC CANNULA WAS REMOVED, AND TEE DEMONSTRATED A MILD RESIDUAL ATRIAL SEPTAL DEFECT WITH LEFT-TO-RIGHT SHUNTING AND NO SIGNIFICANT HYPOXEMIA. THERE WERE NO NEW NEUROLOGIC DEFICITS POST PROCEDURE, AND THERE WERE NO IMMEDIATE POSTOPERATIVE COMPLICATIONS. THE PATIENT BLOOD CULTURES SUBSEQUENTLY CLEARED. CULTURE OF THE DEBULKED MATERIAL WAS NEGATIVE, BUT PATHOLOGY OF THE CLOSURE DEVICE-ASSOCIATED ECHODENSITY WAS CONSISTENT WITH THROMBUS. THE PATIENT HAD A PROLONGED HOSPITALIZATION, FURTHER COMPLICATED BY NEW-ONSET REFRACTORY SHOCK DAYS AFTER THE PROCEDURE, ACUTE HYPOXIC RESPIRATORY FAILURE REQUIRING INTUBATION, AND ACUTE RENAL FAILURE REQUIRING HEMODIALYSIS. THE FAMILY REQUESTED TRANSITION TO COMFORT CARE, AND THE PATIENT SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505427 WATCHMAN FLX? PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60270 00191506004606

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention| H| D