BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 4093407 · Received September 16, 2014

    Report

    Report Number
    2015691-2014-02158
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTION FOR USE (IFU), VALVE STENOSIS IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. AT THIS TIME THE SAPIEN VALVE IS INDICATED FOR USE IN THE AORTIC POSITION. USE OF THE SAPIEN VALVE IN THE PULMONIC POSITION IS STILL IN CLINICAL STUDY. 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. THERE IS LIMITED INFORMATION AVAILABLE IN THE LITERATURE REGARDING PROSTHETIC VALVE FAILURE (PVF) IN PULMONIC VALVE REPLACEMENT. ACCORDING TO A RETROSPECTIVE ANALYSIS OF OUTCOMES OF 169 CONSECUTIVE PATIENTS, ¿RISK FACTORS FOR PROSTHESIS FAILURE IN PULMONARY VALVE REPLACEMENT¿, YOUNGER AGE, TETRALOGY OF FALLOT, AND USE OF A HOMOGRAFT VALVE WERE RISK FACTORS FOR EARLY PVF. ONLY YOUNGER AGE AT PVR WAS A SIGNIFICANT RISK FACTOR FOR LATE PVF. THIS YOUNG MALE PATIENT HAD PULMONARY ATRESIA WITH VSD. AT THE AGE OF 13 THE PATIENT UNDERWENT IMPLANTATION OF A SAPIEN VALVE IN THE PULMONIC POSITION DUE TO A STENOTIC HOMOGRAFT. THE CAUSE OF THE PULMONIC VALVE STENOSIS CANNOT BE DETERMINED, HOWEVER, YOUNGER AGE AT THE TIME OF PVR MAY HAVE BEEN A CONTRIBUTING FACTOR. COMPLAINT HISTORIES ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS EUROPEAN AFFILIATE, APPROXIMATELY 3 YEARS POST IMPLANTATION OF A 23MM SAPIEN VALVE IN THE PULMONIC POSITION, THE VALVE WAS EVALUATED VIA ECHOCARDIOGRAM WHICH SHOWED THE PATIENT HAD A HIGH GRADIENT AND STIFFER LEAFLETS WHICH WERE NO LONGER WORKING PROPERLY. THE DECISION WAS MADE TO IMPLANT A 23MM SAPIEN 3 VALVE. PER REPORT, DURING THE PATIENT¿S EARLY CHILDHOOD THE PATIENT HAD BEEN IMPLANTED WITH A HOMOGRAFT DUE TO HIS PULMONARY ATRESIA WITH VSD. WHEN THE HOMOGRAFT LATER BECAME STENOTIC THE DECISION WAS MADE TO IMPLANT THE 23MM SAPIEN VALVE, WHICH AT THE TIME WAS CONSIDERED TO BE SHORT ENOUGH TO NOT REACH TOO DEEP INTO THE PULMONIC ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571808 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male Required Intervention