BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM

    MDR report key: 8147572 · Received December 10, 2018

    Report

    Report Number
    2134265-2018-63715
    Event Type
    Injury
    Date Received
    December 10, 2018
    Date of Event
    November 15, 2018
    Report Date
    December 10, 2018
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    PMA / PMN Number
    DEN160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A STROKE DURING THE PROCEDURE. A SENTINEL CEREBRAL PROTECTION SYSTEM WAS SELECTED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. THE DEVICE WAS INSERTED INTO THE RIGHT RADIAL. THEY DO NOT KNOW WHETHER THE STROKE WAS DUE TO THE DEVICE BECAUSE THE ACCESS WAS FROM THE LEFT CAROTID ARTERY SO THEY DON'T KNOW IF IT WAS THE DEVICE OR FROM THE ACTUAL ACCESS. THE STROKE WAS FOUND THROUGH MRI CT. ONLY ONE OF THE TWO FILTERS WERE DEPLOYED. THE STROKE WAS RESOLVED WITH A HEPARIN DRIP AND THE PATIENT WAS RELEASED FROM THE HOSPITAL. NO FURTHER COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986493 SENTINEL CEREBRAL PROTECTION SYSTEM EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention