BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 4191118 · Received October 21, 2014

    Report

    Report Number
    3004478276-2014-00056
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 22, 2014
    Manufacturer
    SORIN GROUP CANADA INC.
    Product Code
    DYE
    PMA / PMN Number
    P060038/S002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLETE MANUFACTURING AND MATERIAL RECORDS FOR THE SUBJECT VALVE WERE PULLED AND REVIEWED BY QUALITY CONTROL AT SORIN GROUP (B)(4) THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A LXA21 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. FURTHER, A COMPLETE REVIEW OF THE FUNCTION TEST VIDEO PERFORMED BEFORE THE RELEASE CONFIRMED THE CORRECT FUNCTIONALITY OF THIS VALVE PRIOR TO RELEASE. DEVICE IS IN THE PROCESS OF BEING RETURNED TO THE MANUFACTURER FOR EVALUATION. THE FULL HISTOPATHOLOGICAL EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THIS MITROFLOW VALVE WAS EXPLANTED AFTER 6 YEARS DUE TO A REPORTED PROSTHETIC STENO-INSUFFICIENCY. LEAFLETS CALCIFICATION, DETECTED WITH VISUAL, X-RAY AND HISTOLOGICAL ANALYSES, CAUSED STIFFENING AND LED TO PROGRESSIVE VALVE STENOSIS. PANNUS TISSUE OVERGROWTH INTO THE INFLOW LUMEN ALSO CONTRIBUTED TO VALVE STENOSIS. AORTIC INSUFFICIENCY LIKELY RESULTED FROM LEAFLETS TEARS AND INADEQUATE LEAFLET COAPTATION CAUSED BY CALCIFICATION OF THE LEAFLETS. THERE WAS NO EVIDENCE OF ENDOCARDITIS IN THE RETURNED VALVE. AS REPORTED IN THE SCIENTIFIC LITERATURE, STRUCTURAL DYSFUNCTION IS THE MAJOR CAUSE OF FAILURE OF BIOPROSTHETIC HEART VALVES AND THE PRINCIPAL UNDERLYING PATHOLOGIC PROCESS IS CUSPAL CALCIFICATION. CALCIFICATION CAN ALSO CAUSE STENOSIS DUE TO CUSPAL STIFFENING. CALCIFIC DEPOSITS ARE USUALLY LOCALIZED TO CUSPAL TISSUE (INTRINSIC CALCIFICATION). HISTOLOGICAL ANALYSIS SHOWED THE PRESENCE OF LIPID INFILTRATION (CHOLESTEROL CLEFTS) IN THE PERICARDIAL TISSUE. THIS LIPID INFILTRATION, AS SUPPORTED FROM THE SCIENTIFIC LITERATURE, MAY CONTRIBUTE TO LOCALIZED LEAFLET STIFFNESS, AND IF ASSOCIATED WITH A DEGENERATION OF COLLAGEN FIBERS, AS DETECTED IN THE SAMPLES FROM THIS VALVE, MAY ALSO LEAD TO LEAFLET TEARING. IT IS POSSIBLE THAT THE PATIENT'S CLINICAL CONDITIONS AND RISK FACTORS (DYSLIPIDEMIA, ALCOHOL, TOBACCO, AND VALVULAR AORTIC CARDIOPATHY) MAY HAVE CONTRIBUTED TO THE STRUCTURAL VALVE DETERIORATION OBSERVED IN THIS MITROFLOW VALVE.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2014 THAT A MITROFLOW AORTIC PERICARDIAL HEART VALVE, MODEL LXA, SIZE 21 WAS EXPLANTED AFTER 6.0 YEARS. THIS MALE PATIENT HAD A THREE-YEAR EVOLUTION OF DYSPNEA DUE TO MODERATE EFFORT, THORACIC PAIN. ECG DOCUMENTED PROSTHETIC VALVULAR DYSFUNCTION WITH A RE-STENOSIS OF THE BIOPROSTHETIC SINCE (B)(6) 2012. THIS WAS CONFIRMED THROUGH A TRANSESOPHAGIC ECG ON (B)(6) 2013. HE WAS ON WAITING LIST SINCE 2013 FOR A RE-OPERATION. HE HAD A CARDIAC INSUFFICIENCY ON (B)(6) 2014 ASSOCIATED WITH THE VALVULOPATHY. VALVE WAS REPLACED ON THE (B)(6) 2014 WITH ANOTHER MITROFLOW, SIZE 21. THE VALVE IMPLANTED IN 2008 IS COMPLETELY COVERED IN FIBER AND IS ALSO CALCIFIED.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2014 THAT A MITROFLOW AORTIC PERICARDIAL HEART VALVE, MODEL LXA, SIZE 21 S/N (B)(4) WAS EXPLANTED AFTER 6.0 YEARS. THIS MALE PATIENT HAD A THREE-YEAR EVOLUTION OF DYSPNEA DUE TO MODERATE EFFORT, THORACIC PAIN. ECG DOCUMENTED PROSTHETIC VALVULAR DYSFUNCTION WITH A RESTENOSIS OF THE BIOPROSTHETIC SINCE (B)(6) 2012. THIS WAS CONFIRMED THROUGH A TRANSESOPHAGIC ECG ON (B)(6) 2013. HE WAS ON WAITING LIST SINCE 2013 FOR A RE-OPERATION. HE HAD A CARDIAC INSUFFICIENCY ON (B)(6) 2014 ASSOCIATED WITH THE VALVULOPATHY. VALVE WAS REPLACED ON THE (B)(6) 2014 WITH ANOTHER MITROFLOW, SIZE 21. THE VALVE IMPLANTED IN 2008 IS COMPLETELY COVERED IN FIBER AND IS ALSO CALCIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670277 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE, HEART VALVE DYE SORIN GROUP CANADA INC. LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention