BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE, 26MM

    MDR report key: 4110394 · Received September 23, 2014

    Report

    Report Number
    2015691-2014-02210
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTION FOR USE (IFU), VALVE STENOSIS IS A 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, WITH THE INFORMATION PROVIDED, THE EXACT CAUSE OF THE AORTIC VALVE STENOSIS CANNOT BE CONFIRMED. THE HOSPITAL WILL NOT PROVIDE ADDITIONAL INFORMATION TO EDWARDS FOR FURTHER REVIEW. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    APPROXIMATELY 2 YEARS AND 6 MONTHS POST IMPLANTATION OF A SAPIEN VALVE, THE PATIENT UNDERWENT A VALVE-IN-VALVE PROCEDURE TO RESOLVE STENOSIS OF THE BIOPROSTHETIC VALVE; A COREVALVE WAS IMPLANTED. AS REPORTED, THE PATIENT HAD MULTIPLE ADMISSIONS FOR CONGESTIVE HEART FAILURE. THE LATEST ECHO (2 YEARS AND 5 MONTHS) REVEALED AN AORTIC VALVE AREA OF 0.76CM2, MEAN GRADIENT OF 37MMHG, AORTIC VELOCITY 3.7 M/S. MILD AORTIC INSUFFICIENCY (AI) WAS NOTED. NO FURTHER INFORMATION CAN BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592326 EDWARDS SAPIEN TRANSCATHETER HEART VALVE, 26MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention