BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT

    MDR report key: 3260248 · Received August 1, 2013

    Report

    Report Number
    2015691-2013-20718
    Event Type
    Injury
    Date Received
    August 1, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 3, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P870056/S006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE SOURCE OF THE CALCIFICATION COULD NOT BE ASSESSED. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED, IT APPEARS THAT THE PATIENT'S STENOSIS WAS LIKELY CAUSED BY THE REPORTED CALCIFICATION. CALCIFICATION PLAYS A MAJOR ROLE IN THE FAILURE OF BIOPROSTHETIC HEART VALVES. CALCIFICATION OF VALVES OCCURS AS A PROGRESSIVE, TIME-DEPENDENT PROCESS. TISSUE VALVE CALCIFICATION IS INITIATED PRIMARILY WITHIN RESIDUAL CELLS THAT HAVE BEEN DEVITALIZED, USUALLY BY GLUTARALDEHYDE PRETREATMENT. THE PROCESS OF CALCIFICATION INVOLVES THE REACTION OF CALCIUM-CONTAINING EXTRACELLULAR FLUID WITH MEMBRANE-ASSOCIATED PHOSPHORUS, CAUSING CALCIFICATION OF THE CELLS. INITIAL CALCIFICATION DEPOSITS EVENTUALLY ENLARGE AND GROW INTO A MASS, WHICH STIFFEN AND WEAKEN THE TISSUE AND THEREBY CAUSE THE PROSTHESIS TO MALFUNCTION. THE MINERALIZATION OF A BIOMATERIAL IS GENERALLY ENHANCED AT THE SITES OF INTENSE MECHANICAL DEFORMATIONS GENERATED BY MOTION, SUCH AS THE POINTS OF FLEXION IN HEART VALVES. ULTIMATELY, THE RESULT OF CALCIFICATION IS VALVE FAILURE DUE TO TEARING OR STENOSIS. CALCIFIC DEGENERATION IS A COMMON CAUSE OF BIOPROSTHETIC HEART VALVE FAILURES. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.), MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE, AND GLUTARALDEHYDE FIXATION OF TISSUE. OF THESE, THE FIXATION PROCESS IS A RELATIVELY MINOR CONTRIBUTOR TO CALCIFICATION FOR EDWARDS' TISSUE VALVES DUE TO ANTI-CALCIFICATION TREATMENTS DURING MANUFACTURING. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESES FROM CALCIFYING. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE PULMONARY VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 11 YEARS DUE TO STENOSIS WTIH CALCIFICATION. PER THE OP REPORT, THIS PATIENT IS S/P PULMONARY VALVE REPLACEMENT (PVR) IN 2002, AT AGE (B)(6). ABOUT A MONTH AGO, HE HAD A CARDIAC CATHETERIZATION THAT OBSERVED 2 SMALL ASDS. ONE OF THEM WAS ABLE TO BE CLOSED WITH A DEVICE, THE OTHER ONE REMAINS OPEN. PATIENT WAS REFERRED FOR REDO-PVR. THE DEVICE WAS REPLACED WITH A NEW EDWARDS PROSTHETIC VALVE. NO OPERATIVE COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360744 CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 4300

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R