BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2830834 · Received November 13, 2012

    Report

    Report Number
    2015691-2012-18646
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 16, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE SOURCE OF THE REPORTED CALCIFICATION COULD NOT BE ASSESSED SINCE THE SUBJECT DEVICE WAS NOT EXPLANTED FROM THE PATIENT. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED, IT APPEARS THAT THE STENOSIS WAS MOST LIKELY CAUSED BY THE CALCIFICATION IN THIS CASE. 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.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE PATIENT HAD RE-OPERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 10 YEARS AND 6 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THIS PATIENT HAD DEVELOPED PROSTHETIC AORTIC VALVE STENOSIS DUE TO CALCIFICATION. IT WAS DECIDED TO REPLACE THE PATIENT'S AORTIC VALVE VIA TRANSAPICAL TRANSCATHETER VALVE-IN-VALVE INSERTION. THE EDWARDS TRANSCATHETER VALVE WAS IMPLANTED WITHOUT DIFFICULTY. THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R