BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT THEON¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 1883712 · Received October 27, 2010

    Report

    Report Number
    2015691-2010-14261
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. REQUESTS WERE MADE FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE THE COMPLAINT DEVICE WAS DISCARDED, THUS NO FURTHER INVESTIGATION CAN BE PERFORMED. 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

    IT WAS REPORTED THAT A MITRAL PERICARDIAL BIOPROSTHESIS WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 46 MONTHS DUE TO UNKNOWN REASONS. THE DEVICE WILL BE RETURNED BY THE HOSPITAL STAFF. PLEASE REFERENCE RELATED COMPLAINT (B)(4), 3000TFX, 21MM, (B)(4). PER EMAIL RESPONSE RECEIVED ON 06-OCT-2010 FROM THE SURGEON, THE PATIENT HAS NORMAL RENAL FUNCTION AND NO ENDOCARDITIS.

    Description of Event or Problem · 1

    PER OPERATIVE REPORT, IT WAS LEARNED THAT PATIENT EXHIBITED INCREASING SHORTNESS OF BREATH, DYSPNEA ON EXERTION, FATIGUE, AND CONGESTIVE HEART FAILURE. TEE SHOWED SEVERE BIOPROSTHESIS AORTIC STENOSIS AND SEVERE BIOPROSTHETIC MITRAL REGURGITATION. BOTH AORTIC ( REF MFR REPORT # 2015691-2010-14260) AND MITRAL (SUBJECT DEVICE) BIOPROSTHESIS WERE EXPLANTED. THE AORTIC VALVE LEAFLETS WERE COMPLETELY THICKENED AND FULLY CALCIFIED. OF NOTE, THE VALVE WAS VERY NICELY SEEDED. THE MITRAL VALVE WAS INCREDIBLY CALCIFIED, ALMOST IMMOBILE; THERE WAS A WIDE OPEN CENTRAL JET OF MITRAL REGURGITATION ON TEE. NO EVIDENCE OF PERIVALVULAR LEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT THEON¿ PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX R-06J0395

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention