BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARBOMEDICS TOP HAT MECHANICAL HEART VALVE

    MDR report key: 12917745 · Received December 2, 2021

    Report

    Report Number
    3005687633-2021-00166
    Event Type
    Death
    Date Received
    December 2, 2021
    Date of Event
    September 24, 2021
    Report Date
    January 14, 2022
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWQ
    UDI-DI
    08022057012890
    PMA / PMN Number
    P900060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN DISPOSITION.

    Additional Manufacturer Narrative · 0

    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. SINCE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER (DISPOSITION UNKNOWN) NO FURTHER INVESTIGATIONS IS POSSIBLE AT THIS TIME. THE MANUFACTURER ATTEMPTED TO RETRIEVE ADDITIONAL INFORMATION FROM THE HOSPITAL BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. BASED ON THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO ESTABLISH A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT. HOWEVER, FROM THE DOCUMENT REVIEW PERFORMED, NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED. FURTHERMORE, THE MANUFACTURER DID NOT RECEIVE ANY ALLEGATION OF A DEVICE MALFUNCTIONS NOR OF ADVERSE EVENT FOR THIS DEVICE (EVENT NOTIFIED FROM THE PATIENT REGISTRATION FORM RECEIVED). ULTIMATELY, THE ROOT CAUSE REMAINS UNKNOWN. SHOULD ANY FURTHER INFORMATION BE RECEIVED IN THE FUTURE, THE MANUFACTURER WILL PROVIDE A FOLLOW UP REPORT AS APPLICABLE.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CARBOMEDICS TOP HAT VALVE S5-019 WAS IMPLANTED ON (B)(6) 2021. THE FORM ALSO INDICATED THAT THE PATIENT PASSED AWAY ON THE SAME DAY. AS REPORTED, THE PATIENT RECEIVED MULTIPLE VALVE REPLACEMENTS. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813252 CARBOMEDICS TOP HAT MECHANICAL HEART VALVE MECHANICAL HEART VALVE PROSTHESIS LWQ CORCYM S.R.L. CPHV 08022057012890

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Death