BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM (US)

    MDR report key: 8170228 · Received December 17, 2018

    Report

    Report Number
    2134265-2018-63874
    Event Type
    Injury
    Date Received
    December 17, 2018
    Date of Event
    December 5, 2018
    Report Date
    January 8, 2019
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    PMA / PMN Number
    DEN160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIBE EVENT OR PROBLEM AND OTHER RELEVANT HISTORY - UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A STROKE OCCURRED. A SENTINEL EMBOLIC PROTECTION DEVICE HAD BEEN USED IN A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. POST PROCEDURE, THE PATIENT HAD A STROKE. THE STROKE WAS RESOLVED. THE PATIENT IS FINE. IT WAS FURTHER REPORTED THAT THE PATIENT BECAME CONFUSED APPROXIMATELY EIGHT (8) HOURS FOLLOWING THE PROCEDURE. THE STROKE WAS EMBOLIC. THE PATIENT IS PROGRESSING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STROKE OCCURRED. A SENTINEL EMBOLIC PROTECTION DEVICE HAD BEEN USED IN A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. POST PROCEDURE, THE PATIENT HAD A STROKE. THE STROKE WAS RESOLVED. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008711 SENTINEL CEREBRAL PROTECTION SYSTEM (US) EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other