BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 5212609 · Received November 9, 2015

    Report

    Report Number
    3004478276-2015-00052
    Event Type
    Injury
    Date Received
    November 9, 2015
    Date of Event
    July 30, 2015
    Report Date
    November 3, 2015
    Manufacturer
    SORIN GROUP CANADA INC.
    Product Code
    DYE
    PMA / PMN Number
    P060038/S002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: MODEL #/LOT #, EVALUATION CODES. CORRECTION: EVALUATION CODES. BECAUSE DEVICE WAS NOT RETURNED AND NO FURTHER INFORMATION WAS AVAILABLE, THE INVESTIGATION WAS LIMITED TO REVIEW OF THE DEVICE HISTORY RECORDS REVIEW. THE COMPLETE MANUFACTURING AND MATERIAL RECORDS FOR THE SUBJECT VALVE WERE PULLED AND REVIEWED BY QUALITY CONTROL AT LIVANOVA (B)(4)CORP. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A LXA, SIZE 19 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. 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 PATIENT ARE DIFFICULT TO PREDICT . IT IS POSSIBLE THAT THE PATIENT'S CLINICAL CONDITIONS AND RISK FACTORS MAY HAVE CONTRIBUTED TO THE STRUCTURAL VALVE DETERIORATION OBSERVED IN THIS MITROFLOW VALVE. THE DEVICE WAS IMPLANTED IN (B)(6) PATIENT. THE INSTRUCTION FOR USE STATES THAT THE PATIENTS UNDER 55 YEARS OF AGE MAY EXPERIENCE ACCELERATED CALCIFICATION OF BIOPROSTHETIC DEVICES. AS INDICATED IN 2014 AHA/ACC GUIDELINE FOR THE MANAGEMENT OF PATIENTS WITH VALVULAR HEART DISEASE: PATIENTS <60 YEARS OF AGE AT THE TIME OF VALVE IMPLANTATION HAVE A HIGHER INCIDENCE OF PRIMARY STRUCTURAL DETERIORATION AND A RE-OPERATION RATE AS HIGH AS 40% FOR PATIENTS 50 YEARS OF AGE, 55% FOR PATIENTS 40 YEARS OF AGE, 75% FOR PATIENTS 30 YEARS OF AGE, AND 90% FOR PATIENTS 20 YEARS OF AGE.

    Description of Event or Problem · 1

    PT WAS BORN WITH A BICUSPID AORTIC VALVE AND MIXED AORTIC VALVE DISEASE. HE HAS CEREBRAL PALSY, DYSMORPHIC FEATURES, AND FAILURE TO THRIVE. HE HAD 3 PRIOR AORTIC VALVE REPAIRS AND THEN AORTIC VALVE REPLACEMENT WITH A 19 MM MITROFLOW IN (B)(6) 2012 , AT (B)(6) OF AGE . IN (B)(6) 2015, 6 MONTHS PRIOR TO HIS LAST SURGERY, TWO OF THE MITROFLOW VALVE LEAFLETS WERE NOTED TO BE THICKENED AND POORLY MOBILE, THOUGH WITH A LOW GRADIENT OF 22 MM HG. HE HAD A FOLLOW UP ECHOCARDIOGRAM IN (B)(6) 2015 DEMONSTRATING SEVERE AORTIC VALVE STENOSIS WITH A GRADIENT OF 80 MM HG AND ONLY MILD AORTIC REGURGITATION FOR WHICH HE WAS REFERRED FOR SURGICAL VALVE REPLACEMENT. HE WAS BROUGHT TO THE OPERATING ROOM ON (B)(6) 2015, AT (B)(6) OF AGE. THE VALVE WAS NOTED TO BE HEAVILY CALCIFIED WITH TWO FIXED AND IMMOBILE LEAFLETS. HE UNDERWENT A ROSS PROCEDURE (PULMONARY AUTOCRAFT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740351 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE HEART VALVE DYE SORIN GROUP CANADA INC. LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| L| O| R