BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARBOMEDICS TOP HAT MECHANICAL HEART VALVE

    MDR report key: 11605743 · Received April 1, 2021

    Report

    Report Number
    3005687633-2021-00108
    Event Type
    Death
    Date Received
    April 1, 2021
    Date of Event
    November 13, 2020
    Report Date
    September 24, 2021
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWQ
    UDI-DI
    08022057012913
    PMA / PMN Number
    P900060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS A2, A3, B4, D3, G1, G3, G6, H1, H2, H6. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO ESTABLISH A DEFINITIVE ROOT CAUSE ON THE REPORTED EVENT. HOWEVER, PER THE DOCUMENT REVIEW PERFORMED, NO MANUFACTURING DEFICITS WERE IDENTIFIED. THE MANUFACTURER HAS REACHED OUT TO THE HOSPITAL TO RETRIEVE ADDITIONAL INFORMATION ON THIS EVENT BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. AS THE MANUFACTURER IS UNABLE TO PERFORM ANY ADDITIONAL INVESTIGATION, THE CASE IS CONSIDERED CLOSED AT THIS TIME. SHOULD THE MANUFACTURER RECEIVE ADDITIONAL INFORMATION AT A LATER STAGE, THE CASE WILL BE RE-OPENED AND FURTHER ACTIONS WILL BE TAKEN AS DEEMED APPLICABLE.

    Additional Manufacturer Narrative · 1

    DHR REVIEW HAS BEEN COMPLETED. A COMPLETE MANUFACTURING AND MATERIAL RECORDS REVIEW FOR THE DEVICE HAS BEEN PERFORMED. THE RESULTS CONFIRMED THAT THE DEVICE SATISFIED ALL MATERIAL, VISUAL AND PERFORMANCE STANDARDS REQUIRED AT THE TIME OF MANUFACTURE AND RELEASE. UNKNOWN DISPOSITION.

    Description of Event or Problem · 1

    THE MANUFACTURE WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A S5-023 VALVE WAS IMPLANTED ON (B)(6) 2020 AND THE PATIENT PASSED AWAY. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO INDICATION OF A DEVICE MALFUNCTION WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502684 CARBOMEDICS TOP HAT MECHANICAL HEART VALVE MECHANICAL HEART VALVE PROSTHESIS LWQ CORCYM S.R.L. CPHV 08022057012913

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death