BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTINEL

    MDR report key: 22998863 · Received September 8, 2025

    Report

    Report Number
    2124215-2025-61758
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    March 10, 2025
    Report Date
    October 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PUM
    PMA / PMN Number
    K192460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ADDITIONAL INFORMATION ADDED. G4: DEN160043 REPORTED HERE AS THE PMA # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EXTENDED HOSPITALIZATION OCCURRED. A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WAS PERFORMED WITH USE OF A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) FOR EMBOLIC PROTECTION. THE PATIENT WAS NOT DISCHARGED UNTIL 30 DAYS AFTER THE PROCEDURE. DESPITE GOOD FAITH EFFORTS, NO ADDITIONAL INFORMATION WAS OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EXTENDED HOSPITALIZATION OCCURRED. A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WAS PERFORMED WITH USE OF A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) FOR EMBOLIC PROTECTION. THE PATIENT WAS NOT DISCHARGED UNTIL 30 DAYS AFTER THE PROCEDURE. DESPITE GOOD FAITH EFFORTS, NO ADDITIONAL INFORMATION WAS OBTAINED. IT WAS FURTHER REPORTED THAT THE PATIENT DIED ON (B)(6) 2025, 38 DAYS POST-TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE DUE TO SEPSIS. THE PHYSICIAN ASSESSED THE CAUSE OF DEATH TO BE UNRELATED TO THE SENTINEL DEVICE. ASSESSMENT OF THE RELATIONSHIP BETWEEN THE EXTENDED HOSPITALIZATION AND THE PATIENT DEATH WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441356 SENTINEL TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES PUM BOSTON SCIENTIFIC CORPORATION CMS15-10C-US 0034845271

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Hospitalization