BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 4884552 · Received July 1, 2015

    Report

    Report Number
    2015691-2015-01588
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    August 2, 2004
    Report Date
    April 21, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION AND DEVICE RETURN WERE UNSUCCESSFUL. WITHOUT DEVICE RETURN OR ADDITIONAL INFORMATION THE ROOT CAUSE OF THE EVENT REMAINS INDETERMINABLE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. 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 LEARNED THROUGH MEDICAL LITERATURE ARTICLE " ANALYSIS OF PROSTHETIC CARDIAC DEVICES: A GUIDE FOR THE PRACTISING PATHOLOGIST." PUBLISHED ON JOURNAL CLINICAL PATHOLOGY 2005; 58:113-124. ABSTRACT: PATHOLOGISTS ALL OVER THE WORLD INCREASINGLY ENCOUNTER PROSTHETIC CARDIAC DEVICES. A GOOD EVALUATION OF THESE DEVICES IS A VALUABLE SOURCE OF INFORMATION, WHICH CAN CONTRIBUTE TO PATIENT CARE AND THE APPRECIATION AND UNDERSTANDING OF THE PATHOBIOLOGY INVOLVED IN THE CHANGES OCCURRING BETWEEN THE HOST AND THE IMPLANTED PROSTHETIC DEVICE. THIS ARTICLE SUMMARIZES THE CONSIDERATIONS UNDERLYING THE ANALYSIS OF PROSTHETIC DEVICES (PARTICULARLY PROSTHETIC HEART VALVES), INCLUDING THE IDENTIFICATION OF THE DEVICES, THE MAJOR MORPHOLOGICAL FEATURES OF THE DEVICES, THEIR MODES OF FAILURE, AND SOME TECHNICAL DETAILS ABOUT EVALUATION AND PITFALLS. IN THIS CASE, EDWARDS LEARNED THAT A PERICARDIAL VALVE THAT WAS EXPLANTED AFTER AN UNKNOWN IMPLANT DURATION DUE TO UNKNOWN REASONS, SHOWED SOFT, PLIABLE, INTACT CUSPS AND GOOD COAPTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428972 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R