BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2962416 · Received February 14, 2013

    Report

    Report Number
    2015691-2013-19278
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 16, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COPIES OF THE PATIENT'S MEDICAL RECORDS WERE PROVIDED WHICH SUPPORT THE INITIAL REPORT OF STENOSIS AND CALCIFICATION. THE PATIENT HAD TTE WHICH SHOWED A SEVERELY CALCIFIED ANNULUS. THE VALVE WAS TRILEAFLETS, MODERATELY THICKENED AND CALCIFIED LEAFLETS. THE PROSTHETIC VALVE APPEARED TO BE FUNCTION NORMALLY STATUS POST VALVE REPLACEMENT. THERE WAS NO AORTIC INSUFFICIENCY. THE PATIENT WAS DISCHARGED HOME.

    Additional Manufacturer Narrative · 1

    DEVICE NOT EXPLANTED FROM PATIENT; SAMPLE EVALUATION NOT POSSIBLE. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, SINCE THE VALVE WAS NOT EXPLANTED FROM THE PATIENT, EDWARDS COULD NOT ASSESS THE SOURCE OF THE REPORTED CALCIFICATION. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED, IT APPEARS THAT THE STENOSIS WAS LIKELY CAUSED BY THE 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.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS REPORTED THAT THE PATIENT HAD RE-OPERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 11 YEARS AND 5 MONTHS DUE TO PROSTHETIC AORTIC VALVE STENOSIS WITH CALCIFICATION. AN EDWARDS TRANSCATHETER HEART VALVE WAS IMPLANTED IN THE AORTIC POSITION WITH THE OLD PROSTHETIC STILL IN PLACE. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64698 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R