BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARBOMEDICS TOP HAT MECHANICAL HEART VALVE

    MDR report key: 18986344 · Received March 27, 2024

    Report

    Report Number
    3005687633-2024-00104
    Event Type
    Death
    Date Received
    March 27, 2024
    Report Date
    August 30, 2024
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWQ
    UDI-DI
    08022057012906
    PMA / PMN Number
    P900060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, G3, G6, H2, H6, H11. NOTE: THE MEDICAL DEVICE PROBLEM CODE HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED. BASED ON THE INFORMATION AVAILABLE TO THE MANUFACTURER, THE DEFINITE ROOT CAUSE OF THE REPORTED EVENT CANNOT ULTIMATELY BE ESTABLISHED. IT SHOULD BE NOTED THOUGH THAT, ACCORDING TO THE FURTHER INFORMATION RECEIVED, THE PATIENT'S ANNULUS SIZE WAS 27 MM, WHICH IS TOO SMALL BOTH FOR A PERCEVAL VALVE SIZE L AND A CARBOMEDICS TOP HAT SIZE 21 MECHANICAL PROSTHESIS ON THE BASIS OF DIMENSIONAL CONSIDERATIONS. AS SUCH, BOTH PROSTHESES WERE UNDERSIZED WITH RESPECT TO THE PATIENT'S ANNULUS DIMENSIONS. IT IS NOT KNOWN TO THE MANUFACTURER IF PECULIAR ANATOMICAL FACTORS COULD HAVE CONTRIBUTED TO THE UNDERSIZING OF THE SELECTED PROSTHESES. WHILE THE REVIEW OF THE MANUFACTURING AND MATERIAL RECORDS OF THE TOP HAT PROSTHESIS INVOLVED IN THE REPORTED EVENT CONFIRMED THAT THIS DEVICE SATISFIED ALL REQUIRED MATERIAL, VISUAL, AND PERFORMANCE STANDARDS AT THE TIME OF MANUFACTURE AND RELEASE, AND NO ANOMALIES WERE FOUND SUGGESTIVE OF A POSSIBLE RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE QUALITY, AN IMPORTANT ASPECT TO BE CONSIDERED IS RELATED TO THE PATIENT'S COMPLICATED CLINICAL SCENARIO, WHICH COULD REASONABLY HAVE CONTRIBUTED TO THE REPORTED PATIENT'S DEATH.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING AND MATERIAL RECORDS FOR THE DEVICE INVOLVED IN THIS EVENT, AS THEY PERTAIN TO THE REPORTED ISSUE, WERE RETRIEVED AND REVIEWED BY THE MANUFACTURER¿S QUALITY ENGINEERING. THE RESULTS CONFIRMED THAT THIS PROSTHESIS SATISFIED ALL REQUIRED MATERIAL, VISUAL, AND PERFORMANCE STANDARDS AT THE TIME OF MANUFACTURE AND RELEASE. H3 OTHER TEXT : UNKNOWN DISPOSITION.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED THAT A PATIENT WHO UNDERWENT A REOPERATION WITH A TOP HAT SIZE 21 AORTIC MECHANICAL VALVE PASSED AWAY. THE TOP HAT VALVE HAD BEEN IMPLANTED TO REPLACE A SUTURELESS AORTIC BIOPROSTHESIS (PERCEVAL PLUS SIZE L, SN (B)(6)) WHICH HAD SHOWN A LEAFLET NOT COAPTING COMPLETELY LEADING TO CENTRAL LEAK. AS PER INFORMATION RECEIVED, THE REOPERATION WAS CARRIED OUT IN THE EVENING OF THE SAME DAY OF PERCEVAL VALVE IMPLANT. APPROXIMATELY 8 HOURS LATER. REPORTEDLY, THE PATIENT WAS ALREADY VERY COMPLICATED. THE PREOPERATIVE ECHOCARDIOGRAPHY WAS SHOWING THE FOLLOWING VALUES: AORTIC VALVE AREA (AVA) 1 SQUARE CENTIMETER WITH A MEAN GRADIENT OF 46/25 MMHG, SEVERE MITRAL REGURGITATION (MR) FOR 2-3 MONTHS, GRADE 2 TRICUSPID REGURGITATION (TR), PULMONARY ARTERY PRESSURE (PAP) OF 45 MMHG, EF %45. THE PATIENT HAD UNDERGONE STENTING OF THE RCA AND CX ARTERIES ONE YEAR BEFORE; THE STENTS WERE FOUND PATENT IN THE PREOPERATIVE CORONARY ANGIOGRAPHY. ACCORDING TO FURTHER INFORMATION RECEIVED, THE PATIENT ANNULUS SIZE WAS 27 MM AND IT WAS CONFIRMED THAT THE TOP HAT MECHANICAL VALVE WAS POSITIONED SUPRA-ANNULARLY.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED THAT A PATIENT WHO UNDERWENT A REOPERATION WITH A CARBOMEDICS TOP HAT AORTIC MECHANICAL VALVE SIZE 21 PASSED AWAY. THE TOP HAT VALVE HAD BEEN IMPLANTED TO REPLACE A SUTURELESS AORTIC BIOPROSTHESIS (PERCEVAL PLUS SIZE L, SN (B)(6)) WHICH HAD SHOWN A LEAFLET NOT COAPTING COMPLETELY LEADING TO CENTRAL LEAK (VIGILANCE REPORTS SUBMITTED TO FDA ON 14-FEB-2024 AND 21-MAR-2024, CORCYM REF. (B)(4)). AS PER INFORMATION RECEIVED, THE REOPERATION WAS CARRIED OUT IN THE EVENING OF THE SAME DAY OF PERCEVAL VALVE IMPLANT. APPROXIMATELY 8 HOURS LATER. REPORTEDLY, THE PATIENT WAS ALREADY VERY COMPLICATED. THE PREOPERATIVE ECHOCARDIOGRAPHY WAS SHOWING THE FOLLOWING VALUES: AORTIC VALVE AREA (AVA) 1 SQUARE CENTIMETER WITH A MEAN GRADIENT OF 46/25 MMHG, SEVERE MITRAL REGURGITATION (MR) FOR 2-3 MONTHS, GRADE 2 TRICUSPID REGURGITATION (TR), PULMONARY ARTERY PRESSURE (PAP) OF 45 MMHG, EF %45. THE PATIENT HAD UNDERGONE STENTING OF THE RCA AND CX ARTERIES ONE YEAR BEFORE; THE STENTS WERE FOUND PATENT IN THE PREOPERATIVE CORONARY ANGIOGRAPHY. THE MANUFACTURER IS FOLLOWING UP WITH THE SITE TO RETRIEVE FURTHER INFORMATION ON THE EVENT AND THE DEVICE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493372 CARBOMEDICS TOP HAT MECHANICAL HEART VALVE MECHANICAL HEART VALVE PROSTHESIS LWQ CORCYM S.R.L. CPHV 08022057012906

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death