BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2964448 · Received February 15, 2013

    Report

    Report Number
    2015691-2013-19300
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 17, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE EXPLANTED DEVICE WAS DISCARDED BY THE HOSPITAL; THEREFORE, THE SOURCE OF THE REPORTED CALCIFICATION COULD NOT BE ASSESSED. 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. IN THIS CASE, THE HEALTHCARE PROVIDER HAS INDICATED THAT THIS WAS AGE RELATED CALCIFICATION. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW UP, COPIES OF THE PATIENT'S MEDICAL RECORDS WERE RECEIVED WHICH SUPPORT THE INITIAL REPORT OF STENOSIS AND CALCIFICATION. PER THE OP REPORT, TEE SHOWED CRITICAL AORTIC STENOSIS WITH PANEL AORTIC VALVE NONFUNCTIONAL AORTIC VALVE PREVIOUSLY PLACED 10 YEARS AGO. THE VALVE WAS CONFIRMED TO BE SEVERELY STENOTIC UPON EXPLANT. THE DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. ECHO SHOWED NO PERIVALVULAR LEAK. THE PATIENT TOLERATED THE PROCEDURE WELL.

    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 VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 10 YEARS DUE TO PROSTHETIC AORTIC VALVE STENOSIS, SECONDARY TO CALCIFICATION. THE HEALTHCARE PROVIDER ALSO NOTED THAT THIS EVENT WAS DUE TO AGE RELATED CALCIFICATION AND NOT A DEVICE MALFUNCTION. THE EXPLANTED DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67613 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R