BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3874456 · Received June 16, 2014

    Report

    Report Number
    2015691-2014-01393
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    December 26, 2013
    Report Date
    April 10, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTION FOR USE (IFU), VALVE STENOSIS AND CENTRAL REGURGITATION ARE POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. PER THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC), VALVE STENOSIS CAN RESULT FROM A NUMBER OF FACTORS, INCLUDING PANNUS, CALCIFICATION, SUPPORT STRUCTURE DEFORMATION (OUT-OF-ROUND CONFIGURATION), TRAUMA (CARDIO-PULMONARY RESUSCITATION, BLUNT CHEST TRAUMA), ENDOCARDITIS, PROSTHETIC VALVE THROMBOSIS, AND NATIVE LEAFLET PROLAPSE IMPEDING PROSTHETIC LEAFLET MOTION. 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. IN THIS CASE, THE CAUSE OF THE AORTIC STENOSIS, REPORTED VALVE CALCIFICATION, AND RESULTING CENTRAL REGURGITATION COULD NOT BE CONFIRMED. THE VALVE CALCIFICATION COULD HAVE BEEN DUE TO THE PROGRESSION OF PRE-EXISTING AORTIC VALVE DISEASE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS 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

    EDWARDS LIFESCIENCES CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY OUR EUROPEAN AFFILIATE, APPROXIMATELY SIX YEARS AFTER THE IMPLANTATION OF A 26MM SAPIEN VALVE, ECHO REVEALED THE VALVE TO BE HIGHLY CALCIFIED, WITH MODERATE CENTRAL REGURGITATION. A VALVE-IN-VALVE WITH A 26MM TRANSCATHETER VALVE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353244 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26W

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention