BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOMEDICS TOP HAT MECHANICAL HEART VALVE

    MDR report key: 11895095 · Received May 27, 2021

    Report

    Report Number
    1718850-2021-01094
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    March 1, 2021
    Report Date
    September 9, 2021
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWQ
    UDI-DI
    08022057012920
    Adverse Event
    Yes
    Report Source
    Distributor 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 ANDRELEASE. THE MANUFACTURER ATTEMPTED TO RETRIEVE ADDITIONAL INFORMATION ON THE REPORTED EVENT AND THE DEVICE INVOLVED. SINCE NO FURTHER INFORMATION WAS RECEIVED AND THE DEVICE WAS NOT RETURNED AFTER THE EXPLANT (UNKNOWNDISPOSITION), 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. THEROOT CAUSE REMAINS UNDETERMINED AT THIS TIME. SHOULD FURTHER INFORMATION BE RECEIVED IN THE FUTURE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    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 S5-025 WAS IMPLANTED ON (B)(6) 2021. THIS VALVE WAS EXPLANTED ON (B)(6) 2021 AND REPLACED WITH A CARBOMEDICS TOP HAT VALVE S5-027. THE MANUFACTURER WAS ALSO INFORMED THAT THE PATIENT PASSED AWAY ON THE SAME DAY AFTER THE IMPLANT OF S5-027 (SUBMITTED SEPARATELY UNDER 3005687633-2021-00132). NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

    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 S5-025 WAS IMPLANTED ON (B)(6) 2021. THIS VALVE WAS EXPLANTED ON (B)(6) 2021 AND REPLACED WITH A CARBOMEDICS TOP HAT VALVE S5-027. THE MANUFACTURER WAS ALSO INFORMED THAT THE PATIENT PASSED AWAY ON THE SAME DAY AFTER THE IMPLANT OF S5-027. (REPORTED SEPARATELY UNDER LN 2021-02792). NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS INDICATED DURING THIS PARTICULAR EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792996 CARBOMEDICS TOP HAT MECHANICAL HEART VALVE MECHANICAL HEART VALVE PROSTHESIS LWQ CORCYM S.R.L. CPHV 08022057012920

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention