BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOMEDICS TOP HAT MECHANICAL HEART VALVE

    MDR report key: 12025763 · Received June 18, 2021

    Report

    Report Number
    1718850-2021-01120
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 18, 2021
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWQ
    UDI-DI
    08022057012890
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2021, A CARBOMEDICS TOP HAT VALVE MODEL S5-019 WAS INTENDED FOR AN AORTIC VALVE REPLACEMENT (NATIVE VALVE) PROCEDURE. AS CONFIRMED, THE DEVICE WAS TESTED WITH THE DEDICATED TESTER AND NO FAULT WAS IDENTIFIED AT THAT TIME. DURING UNCLAMPING, IT WAS IDENTIFIED THAT THE VALVE WAS STUCK WHEN OPENING, SPECIFICALLY, ONE LEAFLET DID NOT OPEN AND DID NOT ALLOW FLOW. AS SUCH, THE SURGEON REMOVED THE DEVICE AND TRIED TO REPOSITION IT IN THE PATIENT, FIRST TESTING THE VALVE WITH THE DEDICATED TESTERS. THEN, THE VALVE WAS REMOVED, AND A NEW CARBOMEDICS STANDARD AORTIC VALVE WAS PUT IN, WHICH WORKED AT THE TIME OF PLACEMENT. AS REPORTED, THE FUNCTIONALITY OF THE TOP HAT VALVE MODEL S5-019 VALVE WAS APPROVED, THE FAILURE WAS DETECTED WHEN UNPINNING AND AT THIS TIME IT WAS REALIZED THAT THE VALVE LEAFLETS DID NOT OPEN. THERE WAS NO BAD POSITION, IT WAS MEASURED, TESTED AND BROKEN WITH THE DEVICE'S GAUGES AND ROTATORS CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924271 CARBOMEDICS TOP HAT MECHANICAL HEART VALVE MECHANICAL HEART VALVE PROSTHESIS LWQ CORCYM S.R.L. CPHV 08022057012890

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention