BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS SUPRAANNULAR BIOPROSTHESIS

    MDR report key: 7133946 · Received December 20, 2017

    Report

    Report Number
    2015691-2017-04412
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    November 27, 2017
    Report Date
    November 27, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EDWARDS RECEIVED ADDITIONAL INFORMATION THROUGH FOLLOW UP WITH THE HEALTHCARE PROVIDER THAT THE PATIENT UNDERWENT THE VALVE IN VALVE PROCEDURE WITH A 23MM TRANSCATHETER VALVE. THE OUTCOME WAS EXCELLENT AND THE PATIENT WAS NOTED TO BE STABLE WITH PLANS TO BE DISCHARGED.

    Additional Manufacturer Narrative · 1

    MODEL #: THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #6625-LP; BRAND NAME: CARPENTIER-EDWARDS® DURAFLEX® LOW PRESSURE MITRAL BIOPROSTHESIS; PMA #P870077. ALTHOUGH BIOPROSTHETIC VALVES HAVE BEEN PROVEN TO HAVE EXCELLENT LONG TERM DURABILITY, FAILURE DOES OCCUR IN A SMALL NUMBER OF VALVES. REPLACEMENT OF A BIOPROSTHETIC VALVE OVER TIME IS MORE LIKELY DUE TO STRUCTURAL VALVE DETERIORATION (SVD) WHICH OCCURS AS A RESULT OF STENOSIS (FROM CALCIFICATION OR HOST TISSUE OVERGROWTH), DEHISCENCE, FIBROSIS OR NON-CALCIFIC DEGENERATION. CALCIFICATION IS A WELL-RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. 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. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESES FROM CALCIFYING. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINED IMPLANTED. THEREFORE, THE ROOT CAUSE FOR THE CALCIFICATION AND STENOSIS REMAINS INDETERMINABLE. HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO A MANUFACTURING DEFICIENCY AND/OR ONE WAS NOT CONFIRMED THROUGH INVESTIGATION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION THAT A 33 MM BIOPROSTHETIC MITRAL VALVE WAS SCHEDULED FOR A VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS AND EIGHT (8) MONTHS DUE TO CALCIFICATION LEADING TO STENOSIS. THE PROCEDURE WAS SCHEDULED BUT NOT PERFORMED YET, A 29 MM TRANSCATHETER VALVE IS PLANNED TO BE IMPLANTED AS REPLACEMENT. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912372 CARPENTIER-EDWARDS SUPRAANNULAR BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 665033MM

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R