BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARBOMEDICS TOP HAT MECHANICAL HEART VALVE

    MDR report key: 18422353 · Received December 29, 2023

    Report

    Report Number
    3005687633-2023-00134
    Event Type
    Death
    Date Received
    December 29, 2023
    Report Date
    February 20, 2024
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWQ
    UDI-DI
    08022057012913
    PMA / PMN Number
    P900060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INDICATION OF DEVICE EXPLANT.

    Additional Manufacturer Narrative · 0

    A COMPLETE MANUFACTURING AND MATERIAL RECORDS REVIEW FOR THE CPHV VALVE S5-023 HAS BEEN PERFORMED. THE RESULTS CONFIRMED THAT THE DEVICE SATISFIED ALL MATERIAL, VISUAL AND PERFORMANCE STANDARDS REQUIRED AT THE TIME OF MANUFACTURE AND RELEASE. BASED ON THE LIMITED INFORMATION AVAILABLE, THE DEFINITIVE ROOT 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 WILL BE PROVIDED.

    Description of Event or Problem · 0

    RECEIVED THE FOLLOWING INFORMATION THROUGH THE PATIENT TRACKING DEPARTMENT. ON (B)(6)2022, A PATIENT RECEIVED A CARBOMEDICS TOP HAT VALVE S5-023. AS REPORTED, THE PATIENT PASSED AWAY AT A LATER DATE (EXACT DATE AND CAUSE UNKNOWN). NO OTHER DETAILS ABOUT THE PATIENT, EVENT OR ALLEGATION OF ANY DEVICE DYSFUNCTION HAVE YET BEEN RECEIVED FROM THE SITE. MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION CAN BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236662 CARBOMEDICS TOP HAT MECHANICAL HEART VALVE MECHANICAL HEART VALVE PROSTHESIS LWQ CORCYM S.R.L. CPHV 08022057012913

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death