BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3011810 · Received March 19, 2013

    Report

    Report Number
    2015691-2013-19589
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    January 21, 2013
    Report Date
    February 19, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE SOURCE OF THE REPORTED CALCIFICATION COULD NOT BE ASSESSED. ALTHOUGH THE ROOT CAUSE CANNOT BE CONFIRMED, IT APPEARS THAT THE STENOSIS WAS LIKELY CAUSED BY THE HEAVY CALCIFICATION NOTED. CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 10 YEARS AND 8 MONTHS DUE TO SEVERE PROSTHETIC AORTIC VALVE STENOSIS AND CALCIFICATION. ACCORDING TO THE OP REPORT, THIS PATIENT PREVIOUSLY HAD AORTIC VALVE REPLACEMENT IN 2002 WITH THE SUBJECT DEVICE. RECENTLY, SHE HAS HAD SEVERAL EPISODES OF FALLING. SHE UNDERWENT EVALUATION, WHICH REVEALED SEVERE PROSTHETIC AORTIC STENOSIS (AS) ON ECHO. UPON EXPLANTATION OF THE VALVE, IT WAS NOTED TO BE WELL-HEALED, BUT ALL THE LEAFLETS WERE HEAVILY CALCIFIED. THE VALVE WAS OBVIOUSLY STENOTIC. ON THE RIGHT CUSP, THERE WAS A BUILD UP OF VERY FRIABLE, EASILY FRAGMENTED CALCIUM. TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED SEVERE AS PRIOR TO BYPASS. AFTER COMPLETION OF THE VALVE REPLACEMENT WITH A NEW EDWARDS PROSTHESIS, IT WAS SHOWN TO BE FUNCTIONING NICELY WITHOUT ANY PERIVALVULAR LEAKS. THE PATIENT TOLERATED THE PROCEDURE SATISFACTORILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113748 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R