BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 7447120 · Received April 20, 2018

    Report

    Report Number
    2015691-2018-01483
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    January 1, 2007
    Report Date
    March 26, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL #: THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #2500P; BRAND NAME: EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS; PMA #P000007. 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, AND/OR ENDOCARDITIS. THE DEVICES WERE NOT RETURNED FOR EVALUATION, AS THEY REMAINED IMPLANTED. IN THIS CASE, MINIMAL INFORMATION REGARDING THESE EVENTS WAS RECEIVED THROUGH A WRITTEN ARTICLE AND ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THE CONDITION OF THE DEVICE, PATIENT'S MEDICAL HISTORY, OR POSSIBLE COMORBIDITIES HAVE BEEN UNSUCCESSFUL. THE ROOT CAUSE OF THE EVENTS REMAINS INDETERMINABLE. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE HISTORY RECORD (DHR) WAS NOT ABLE TO BE REVIEWED AS THE DEVICE SERIAL NUMBER WAS NOT PROVIDED. 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

    THROUGH REVIEW OF ARTICLE "TRANSCATHETER AORTIC VALVE IMPLANTATION IN FAILED BIOPROSTHETIC SURGICAL VALVES -SUPPLEMENTARY ONLINE CONTENT" AUTHORS DVIR D, WEBB JG, BLEIZIFFER S, ET AL. 133 VALVE IN VALVE EVENTS AFTER AN UNKNOWN IMPLANT DURATION WERE IDENTIFIED AS INVOLVING THE FOLLOWING EDWARDS DEVICES: 129 EDWARDS VALVES INCLUDING PERIMOUNT / PERIMOUNT-MAGNA / PORCINE / OTHERS (STENTED VALVES). FOUR (4) EDWARDS PRIMA PLUS VALVES (STENTLESS VALVES). METHODS: THE VIVID REGISTRY WAS INITIATED IN DECEMBER 2010 AND WAS DESIGNED TO COLLECT DATA ON VALVE-IN-VALVE PROCEDURES USING MAINLY SELF-EXPANDABLE COREVALVE (MEDTRONIC) AND BALLOON EXPANDABLE EDWARDS SAPIEN DEVICES (EDWARDS LIFESCIENCES). VALVE-IN-VALVE PROCEDURES PERFORMED USING OTHER TRANSCATHETER DEVICES OR IMPLANTED IN POSITIONS OTHER THAN THE AORTIC VALVE WERE NOT INCLUDED IN THE CURRENT ANALYSES. WE COLLECTED DATA RETROSPECTIVELY FOR CASES PERFORMED BEFORE REGISTRY INITIATION AND PROSPECTIVELY THEREAFTER. A TOTAL OF 55 CENTERS FROM EUROPE, NORTH AMERICA, AUSTRALIA, NEW ZEALAND, AND THE MIDDLE EAST CONTRIBUTED DATA. DATA WERE COLLECTED FOR CASES PERFORMED BETWEEN 2007 AND MAY 2013 USING A DEDICATED CASE REPORT FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288772 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2500P

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R