BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3771257 · Received April 24, 2014

    Report

    Report Number
    2015691-2014-00938
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 26, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: REPORT OF A PATIENT THAT UNDERWENT AN IMPLANT OF A TRANSCATHETER VALVE INSIDE A BIOPROSTHETIC AORTIC VALVE WHICH WAS IMPLANTED TWELVE (12) YEARS AGO. IN THIS CASE, MULTIPLE FOLLOW UP ATTEMPTS WITH THE HEALTHCARE PROVIDER TO OBTAIN EVENT DETAILS WERE UNSUCCESSFUL. IMPLANTATION OF A TRANSCATHETER HEART VALVE INSIDE A DEGENERATED ONE IS A LESS INVASIVE PROCEDURE TO TREAT VALVULAR DISEASE. BIOPROSTHETIC VALVE DYSFUNCTION ENCOMPASSES MULTIPLE FAILURE MODES/MECHANISMS, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF THESE FAILURES INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. HOWEVER, WITHOUT RETURN OF DEVICE AND EVALUATION (REMAINS IMPLANTED), THE SPECIFIC MECHANISM LEADING TO THIS EVENT CANNOT BE IDENTIFIED OR EVALUATED. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT. EDWARDS WILL CONTINUE TO MONITOR ALL EVENTS.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS LEARNED THAT A PATIENT WITH AN IMPLANTED EDWARDS AORTIC VALVE UNDERWENT AN IMPLANT OF A TRANSCATHETER VALVE INSIDE THE SUBJECT DEVICE (VALVE IN VALVE) AFTER AN IMPLANT DURATION OF APPROXIMATELY TWELVE (12) YEARS. THE REASON FOR INTERVENTION HAS NOT BEEN PROVIDED DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249767 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R