BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARBOMEDICS TOP HAT MECHANICAL HEART VALVE

    MDR report key: 22197327 · Received June 12, 2025

    Report

    Report Number
    3005687633-2025-00117
    Event Type
    Death
    Date Received
    June 12, 2025
    Date of Event
    September 16, 2024
    Report Date
    July 18, 2025
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWQ
    UDI-DI
    08022057012920
    PMA / PMN Number
    P900060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING AND MATERIAL RECORDS FOR THE DEVICE INVOLVED IN THIS EVENT, AS THEY PERTAIN TO THE REPORTED ISSUE, WERE RETRIEVED AND REVIEWED BY THE MANUFACTURER¿S QUALITY ENGINEERING. THE RESULTS CONFIRMED THAT THIS PROSTHESIS SATISFIED ALL REQUIRED MATERIAL, VISUAL, AND PERFORMANCE STANDARDS AT THE TIME OF MANUFACTURE AND RELEASE. BASED ON THE LIMITED INFORMATION AVAILABLE, THE DEFINITIVE CAUSE OF THE REPORTED EVENT CANNOT BE ESTABLISHED AT THIS TIME. HOWEVER, FROM THE DOCUMENT REVIEW PERFORMED, NO MANUFACTURING DEFICIENCIES WERE NOTED. SHOULD FURTHER INFORMATION BE RECEIVED IN THE FUTURE, A FOLLOW UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER WILL SUBMIT FOLLOW-UP REPORT UPON AVAILABILITY OF NEW, RELEVANT DETAILS.

    Description of Event or Problem · 0

    MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH DEVICE TRACKING AUDIT CONDUCTED. BASED ON THE INFORMATION AVAILABLE, ON (B)(6) 2021, A CARBOMEDICS TOP-HAT AORTIC HEART VALVE, S5-025 WAS IMPLANTED IN A PATIENT. AS REPORTED, THE PATIENT DIED (B)(6) 2024. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669557 CARBOMEDICS TOP HAT MECHANICAL HEART VALVE MECHANICAL HEART VALVE PROSTHESIS LWQ CORCYM S.R.L. CPHV 08022057012920

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Death