BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 4424560 · Received January 15, 2015

    Report

    Report Number
    3004478276-2014-00075
    Event Type
    Injury
    Date Received
    January 15, 2015
    Date of Event
    December 10, 2014
    Report Date
    January 15, 2015
    Manufacturer
    SORIN GROUP CANADA INC.
    Product Code
    DYE
    PMA / PMN Number
    P060038/S002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF DEVICE HISTORY RECORD (DHR) INDICATED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A LXA MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED ON THE FIELD EXPERIENCE REPORT FORM, THE MITROFLOW VALVE (LXA SIZE 21) WAS EXPLANTED AFTER APPROX. 5 YEARS DUE TO STRUCTURAL VALVE DETERIORATION (I.E., CALCIFICATION, STENOSIS). BECAUSE THE DEVICE WAS NOT RETURNED, SORIN GROUP'S INVESTIGATION WAS LIMITED TO A REVIEW OF THE DEVICE HISTORY RECORDS AND A SCIENTIFIC LITERATURE REVIEW. 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 AN LXA21 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. STRUCTURAL DYSFUNCTION IS THE MAJOR CAUSE OF FAILURE OF BIOPROSTHETIC HEART VALVES. THE PRINCIPAL UNDERLYING PATHOLOGIC PROCESS IS CUSPAL CALCIFICATION; SECONDARY TEARS FREQUENTLY PRECIPITATE REGURGITATION. CALCIFICATION CAN ALSO CAUSE PURE STENOSIS OWING TO CUSPAL STIFFENING. CALCIFIC DEPOSITS ARE USUALLY LOCALIZED TO CUSPAL TISSUE (INTRINSIC CALCIFICATION), BUT CALCIFIC DEPOSITS EXTRINSIC TO THE CUSPS MAY DEVELOP IN THROMBI OR ENDOCARDITIC VEGETATIONS (EXTRINSIC CALCIFICATION)1,2. SEVERAL CLINICAL FACTORS WERE ASSOCIATED WITH AN INCREASING OF THE VALVE DEGENERATION AND CALCIFICATION3 (E.G. AGE, SMOKING, HYPERTENSION, DIABETES, CORONARY HEART DISEASE). THE COMPLEXITY OF THE INTERACTIONS PATIENT-PROSTHESIS, WHICH ARE TRIGGERING THE CALCIFICATION PROCESS, IS ALSO BASED ON INDIVIDUAL PREDISPOSITION, DRUG TREATMENTS AND RISK FACTORS. REFERENCE: 1 FREDERICK J. SCHOEN, MD, PHD, AND ROBERT J. LEVY, MD, CALCIFICATION OF TISSUE HEART VALVE SUBSTITUTES: PROGRESS TOWARD UNDERSTANDING AND PREVENTION; ANN THORAC SURG 1073 2005;79:1072-80. 2V. FREEMAN, MD, MS; CATHERINE M. OTTO, MD, SPECTRUM OF CALCIFIC AORTIC VALVE DISEASE PATHOGENESIS, DISEASE PROGRESSION, AND TREATMENT STRATEGIES, CIRCULATION. 2005;111:3316-3326. 3 STEWART BF, SISCOVICK D, LIND BK, ET AL. CLINICAL FACTORS ASSOCIATED WITH CALCIFIC AORTIC VALVE DISEASE. CARDIOVASCULAR HEALTH STUDY. J AM COLL CARDIOL 1997;29:630-4. (E.G. HYPERTENSION4, DYSLIPIDEMIA5, AND DIABETES6). PATIENT RISK FACTORS MAY HAVE PLAYED A KEY ROLE IN THE STRUCTURAL VALVE DETERIORATION. WE ARE CLOSING THIS CASE AT THIS TIME, AS NO FURTHER EVALUATION IS POSSIBLE.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(4) 2014 THAT A MITROFLOW VALVE (MODEL LXA, SIZE 21) WAS EXPLANTED DUE TO SVD - CALCIFICATION. LIMITED INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2014 THAT A MITROFLOW VALVE (MODEL LXA, SIZE 21) WAS EXPLANTED DUE TO SVD - CALCIFICATION. LIMITED INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35604 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE HEART VALVE DYE SORIN GROUP CANADA INC. LXA21

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention