BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2991298 · Received March 6, 2013

    Report

    Report Number
    2015691-2013-19447
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 5, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT EXPLANTED FROM PATIENT. UNFORTUNATELY, THE DEVICE WAS NOT EXPLANTED FROM THE PATIENT; 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. 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 16 YEARS AND 1 MONTH DUE TO STENOSIS SECONDARY TO CALCIFICATION. ACCORDING TO THE OP REPORT, THIS PATIENT INITIALLY HAD THIS VALVE PLACED IN 1996 FOR AORTIC STENOSIS. SHE NOW HAD BEEN DEVELOPING SYMPTOMS OF LOW-THRESHOLD DYSPNEA AND CHEST DISCOMFORT IN ADDITION TO LYMPHEDEMA AND WEIGHT GAIN BUT WITHOUT ANY HISTORY OF SYNCOPE. OUTSIDE WORKUP REVEALED SEVERE STENOSIS OF THE PROSTHETIC AORTIC VALVE WITH A REPORTED PEAK VELOCITY OF 4.3 M/SEC WITH A PEAK GRADIENT OF 74 AND A CALCULATED VALVE AREA OF 0.2 CM WITH AN EJECTION FRACTION OF 60%. THE PATIENT AGREED TO PROCEED WITH REDO-AORTIC VALVE REPLACEMENT. SUCCESSFUL TRANSFEMORAL AORTIC VALVE REPLACEMENT WAS PERFORMED WITH AN EDWARDS SAPIEN PROSTHETIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96333 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R