BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARBOMEDICS TOP HAT MECHANICAL HEART VALVE

    MDR report key: 11895265 · Received May 27, 2021

    Report

    Report Number
    3005687633-2021-00132
    Event Type
    Death
    Date Received
    May 27, 2021
    Date of Event
    March 1, 2021
    Report Date
    August 2, 2021
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWQ
    UDI-DI
    08022057012937
    PMA / PMN Number
    P900060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE MANUFACTURER ATTEMPTED TO RETRIEVE ADDITIONAL INFORMATION ON THE REPORTED EVENT AND THE DEVICE INVOLVED. SINCE NO FURTHER INFORMATION WAS RECEIVED AND THE DEVICE DISPOSITION IS UNKNOWN (UNKNOWN IF AUTOPSY PERFORMED), NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION TO THE REPORTED EVENT. HOWEVER, PER THE DOCUMENT REVIEW PERFORMED, NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED FOR THE INVOLVED DEVICE. THE ROOT CAUSE REMAINS UNDETERMINED AT THIS TIME. SHOULD FURTHER INFORMATION BE RECEIVED IN THE FUTURE, A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CARBOMEDICS TOP HAT VALVE S5-027 WAS IMPLANTED (B)(6) 2021 TO REPLACE A CARBOMEDICS TOP HAT VALVE S5-025 (SUBMITTED SEPARATELY UNDER 3005687633-2021-00131). THE PATIENT DIED DURING THE SAME DAY. NO ALLEGATION OF A DEVICE MALFUNCTION OR ADVERSE EVENT HAS BEEN RECEIVED FROM THE SITE REGARDING THIS EVENT.

    Additional Manufacturer Narrative · 1

    UNKNOWN DISPOSITION.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CARBOMEDICS TOP HAT VALVE S5-027 WAS IMPLANTED (B)(6) 2021 TO REPLACE A CARBOMEDICS TOP HAT VALVE S5-025 (REF. (B)(4). THE PATIENT DIED DURING THE SAME DAY. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE ABOUT THE CAUSE OF THE EVENT. NO ALLEGATION OF DEVICE MALFUNCTION WAS RECEIVED FROM THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792999 CARBOMEDICS TOP HAT MECHANICAL HEART VALVE MECHANICAL HEART VALVE PROSTHESIS LWQ CORCYM S.R.L. CPHV 08022057012937

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death