BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM

    MDR report key: 8170483 · Received December 17, 2018

    Report

    Report Number
    2134265-2018-63875
    Event Type
    Injury
    Date Received
    December 17, 2018
    Date of Event
    December 7, 2018
    Report Date
    January 14, 2019
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    PMA / PMN Number
    DEN160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIBE EVENT OR PROBLEM: 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. EIGHT (8) HOURS POST PROCEDURE, THE PATIENT HAD A STROKE. IT WAS FURTHER REPORTED THAT THE PATIENT'S COMORBIDITIES ARE UNKNOWN. A NON-BSC 26 VALVE HAD BEEN IMPLANTED IN THE TAVR PROCEDURE. THE PATIENT EXPERIENCED LEFT SIDE FACIAL DROOPINESS WHICH STAYED PERMANENT. IN THE PHYSICIAN'S OPINION, THE STROKE WAS UNRELATED TO THE SENTINEL PROCEDURE.

    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. EIGHT (8) HOURS POST PROCEDURE, THE PATIENT HAD A STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010455 SENTINEL CEREBRAL PROTECTION SYSTEM EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other