BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARBOMEDICS TOP HAT MECHANICAL HEART VALVE

    MDR report key: 16946724 · Received May 17, 2023

    Report

    Report Number
    3005687633-2023-00113
    Event Type
    Death
    Date Received
    May 17, 2023
    Date of Event
    April 18, 2023
    Report Date
    May 17, 2023
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWQ
    UDI-DI
    08022057012906
    PMA / PMN Number
    P900060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLETE MANUFACTURING AND MATERIAL RECORDS REVIEW FOR THE CARBOMEDICS TOP HAT MECHANICAL VALVE, MODEL #S5-021 S/N #(B)(6) 2023, HAS BEEN PERFORMED. THE RESULTS CONFIRMED THAT THE DEVICE SATISFIED ALL MATERIAL, VISUAL AND PERFORMANCE STANDARDS REQUIRED AT THE TIME OF MANUFACTURE AND RELEASE. SINCE MINIMAL INFORMATION WAS SHARED WITH THE MANUFACTURER AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS, A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE ESTABLISHED. HOWEVER, FROM THE DOCUMENT REVIEW PERFORMED, NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED. THE MANUFACTURER HAS BEEN INFORMED THAT NO FURTHER INFORMATION WILL BE SHARED BY THE SITE. THE MANUFACTURER WILL PROVIDE A FOLLOW UP REPORT IN CASE ANY ADDITIONAL INFORMATION IS RECEIVED. H3 OTHER TEXT : UNKNOWN DISPOSITION.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023 A 51 YEAR OLD PATIENT UNDERWENT AVR WITH CARBOMEDICS TOP HAT SUPRA-ANNULAR AORTIC PROSTHESIS SIZE 21. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. ON FIRST POST-OPERATIVE DAY, THE PATIENT EXPERIENCED A SUDDEN DECREASE IN BLOOD PRESSURE AND HEART RATE COULDN'T BE MEASURED. ULTIMATELY, THE PATIENT PASSED AWAY. NO INFORMATION IS AVAILABLE TO THE MANUFACTURER REGARDING PATIENT CLINICAL HISTORY AND RISK FACTORS, DETAILS ON SURGICAL PROCEDURE (E.G. IF CONCOMITANT PROCEDURES WERE PERFORMED). NO DATA ARE AVAILABLE TO THE MANUFACTURER REGARDING DEVICE FUNCTIONALITY POST-OP. IT WAS REPORTED THAT THE SURGEON SUSPECTED THAT PATIENT DEATH WAS CAUSED BY LEAFLET BLOCKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774175 CARBOMEDICS TOP HAT MECHANICAL HEART VALVE MECHANICAL HEART VALVE PROSTHESIS LWQ CORCYM S.R.L. CPHV 08022057012906

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Death