BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2983533 · Received February 28, 2013

    Report

    Report Number
    2015691-2013-19416
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 31, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RESPONSE FROM THE SURGEON WAS RECEIVED INDICATING THAT THIS DEVICE WAS EXPLANTED DUE MITRAL STENOSIS AND CALCIFICATION. ACCORDING TO THE OP REPORT, THIS PATIENT PRESENTED WITH CLASS IV CONGESTIVE HEART FAILURE. HE HAS HAD 4 PREVIOUS OPEN HEART SURGERIES. HIS LAST OPERATION WAS IN 2003, WHEN HE UNDERWENT MEDIAN STERNOTOMY AND REPLACEMENT OF THIS AORTIC VALVE AND AORTIC ROOT, AS WELL AS MITRAL VALVE REPLACEMENT WITH THE SUBJECT DEVICE. SHE HAD DONE WELL SINCE THAT TIME UNTIL RECENTLY, WHEN CARDIAC CATHETERIZATION REVEALED ESSENTIALLY SEVERE MITRAL STENOSIS AND MITRAL REGURGITATION. IT WAS FELT SECONDARY TO PROSTHETIC VALVE MALFUNCTION. UPON EXPLANTATION OF THE DEVICE, IT WAS NOTED TO BE COMPLETELY CALCIFIED WITH FIXED CUSPS. THE DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. THERE WERE NO OPERATIVE COMPLICATIONS REPORTED. THE PATIENT WAS DISCHARGE HOME ON POD #11. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE SOURCE OF CALCIFICATION NOTED ON THE VALVE COULD NOT BE ASSESSED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED, IT APPEARS THAT THE STENOSIS AND REGURGITATION WERE LIKELY CAUSED BY THE CALCIFICATION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. DESPITE ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. CONTINUED ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL DETAILS REGARDING THIS CASE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT ANY NEW INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 9 YEARS AND 8 MONTHS. THE REASON FOR EXPLANT IS UNKNOWN. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. THE DEVICE WAS REPLACED WITH ANOTHER EDWARDS VALVE. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85653 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 3D0691

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R