BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOMEDICS TOP HAT MECHANICAL HEART VALVE

    MDR report key: 12021407 · Received June 17, 2021

    Report

    Report Number
    3005687633-2021-00141
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    May 19, 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
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, AND SINCE THE DEVICE WAS NOT RECEIVED FOR INVESTIGATION, IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION ON THE REPORTED EVENT. HOWEVER, FROM THE DOCUMENT REVIEW PERFORMED, NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED. DESPITE THE DEVICE WAS MADE AVAILABLE FOR RETURN, IT HAS NOT YET BEEN RECEIVED. AS SUCH, NO FURTHER INVESTIGATION IS POSSIBLE AND THE ROOT CAUSE CANNOT BE ESTABLISHED AT THIS TIME. SHOULD THE DEVICE BE RECEIVED IN THE FUTURE, OR SHOULD FURTHER INFORMATION BE PROVIDED, THE MANUFACTURER WILL UPDATE THIS REPORTING ACTIVITY AS APPROPRIATE.

    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. FURTHER INVESTIGATION IS ONGOIN.

    Description of Event or Problem · 0

    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 #18 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 DURING THE WEANING FROM BYPASS AND AT THIS TIME IT WAS REALIZED THAT THE VALVE LEAFLETS DID NOT OPEN. THE VALVE WAS ALREADY SUTURED, AND AT THE TIME OF WEANING FROM BYPASS THERE WAS NO MOVEMENT OF THE LEAFLETS, SO THE PATIENT WAS UNABLE TO EXIT THE EXTRACORPOREAL PUMP. THERE WAS NO BAD POSITION, IT WAS MEASURED, TESTED AND BROKEN WITH THE DEVICE'S GAUGES AND ROTATORS CORRECTLY. THE VALVE WAS REPORTEDLY NOT BROKE OR BROKEN IN THE PROCESS.

    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
    917217 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 Female Required Intervention