BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3062058 · Received April 16, 2013

    Report

    Report Number
    2015691-2013-19831
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 18, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE SOURCE OF THE REPORTED CALCIFICATION 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 CONFIRMED, IT APPEARS THAT THE REGURGITATION WAS 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

    COPIES OF THE PATIENT'S MEDICAL RECORDS WERE RECEIVED WHICH CONCUR WITH THE ORIGINAL REPORT OF CALCIFICATION. PER THE OP REPORT, ECHOCARDIOGRAPHY SHOWED SEVERE PROSTHETIC AORTIC VALVE INSUFFICIENCY, SIGNIFICANT DEGENERATION, AND CALCIFICATION OF THE BIOPROSTHETIC VALVE. CARDIAC CATHETERIZATION CONFIRMED THESE FINDINGS. HE HAS NO SIGNIFICANT CORONARY ARTERY DISEASE. INTRAOPERATIVE FINDINGS CONFIRMED THE EXTENSIVE CALCIFICATION. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED HOME ON POD #5. THERE IS NO CHANGE IN THE ORIGINAL CONCLUSION OF THIS CASE.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE PROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 10 YEARS AND 8 MONTHS DUE TO AORTIC REGURGITATION WITH CALCIFICATION. THE DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. UNFORTUNATELY, NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162683 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 1D0580

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R