BEUDAMED
    FDA Adverse Event Other Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 4284123 · Received August 19, 2014

    Report

    Report Number
    3004478276-2014-00018
    Event Type
    Other
    Date Received
    August 19, 2014
    Date of Event
    December 17, 2013
    Report Date
    May 22, 2014
    Manufacturer
    SORIN GROUP CANADA INC.
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, DIMENSIONAL, AND PERFORMANCE REQUIREMENTS AT THE TIME OF MFR AND RELEASE. CONCLUSION: THE SUBJECT VALVE FAILED DUE TO DEFORMATION AND STIFFENING OF THE LEAFLETS FROM CALCIFICATION OF THE LEAFLETS TISSUE AND FIBROUS PANNUS TISSUE INGROWTH OVER THE INFLOW ASPECT OF THE VALVE. THE MEDICAL LITERATURE CLEARLY STATES THAT CHILDREN IN THIS AGE GROUP ARE AT SIGNIFICANT RISK FOR RAPID DETERIORATION OF IMPLANTED BIOPROSTHETIC CARDIAC VALVES DUE TO EXUBERANT FIBROUS PANNUS FORMATION AND DYSTROPHIC CALCIFICATION OF THE VALVE LEAFLETS. HIGH CALCIUM TURNOVER ACCOMPANYING BONE GROWTH IS THE MOST LIKELY REASON FOR INCREASED RISK IN CHILDREN GENERALLY. THE MEDICAL LITERATURE CONSISTENTLY STATES THAT THE RISK OF RAPID DETERIORATION OF AN IMPLANTED BIOPROSTHETIC VALVE ARE HIGH, ALTHOUGH DUE TO PHYSIOLOGIC VARIABILITY FOR THESE PREDISPOSING METABOLIC PROCESSES, THE RATE OF DETERIORATION IN A GIVEN PT ARE DIFFICULT TO PREDICT. THE DOCUMENT REVIEW CONFIRMED THAT THE VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE MEASURES OF A SIZE 23 MITROFLOW VALVE MODEL LXA AT THE TIME OF MFR AND RELEASE. IN ADDITION, DETAILED AND SYSTEMATIC ANALYSIS THAT ARE PART OF SORIN'S CQA REVEALED NO ADDITIONAL CLINICAL FEATURES, FINDINGS ON DIAGNOSTIC IMAGING OR FINDINGS ON PATHOLOGIC EVAL THAT MIGHT FURTHER BE ATTRIBUTED TO THIS OUTCOME BEYOND THE SUBSTANTIAL RISK IMPOSED BY THE PT'S AGE FOR ANY IMPLANTED BIOPROSTHETIC CARDIAC VALVE.

    Description of Event or Problem · 1

    THE MFR WAS NOTIFIED ON (B)(6) 2013 WITH A MAIL FROM THE HOSPITAL THAT OF A MITROFLOW VALVE (LXA SIZE23) THAT WAS EXPLANTED AFTER 2.5 YEARS DUE TO AN EARLY STRUCTURAL VALVE DETERIORATION DUE TO CALCIFICATION IN A YOUNG PT. ON (B)(6) 2014 THE MFR RECEIVED THE MEDWATCH FORM RELATED TO THE EVENT (MDR# 2233020000-2013-8007). ON (B)(6) 2014, THE VALVE WAS RETURNED TO THE MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497212 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE, HEART VALVE LWR SORIN GROUP CANADA INC. LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| L| R