BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW LXA

    MDR report key: 8442178 · Received March 21, 2019

    Report

    Report Number
    3004478276-2019-00140
    Event Type
    Injury
    Date Received
    March 21, 2019
    Report Date
    March 21, 2019
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: DEVICE DISPOSITION PRESENTLY UNKNOWN.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED OF THE FOLLOWING PAPER WHICH WAS RECEIVED AND REVIEW ON FEB. 24, 2019. DURING THE REVIEW THE FOLLOWING ADVERSE EVENT WAS MENTIONED IN THE PAPER: "IN ADDITION, THREE PATIENTS (1.3%) UNDERWENT RE-OPERATION FOR ENDOCARDITIS RESPECTIVELY AT 13, 24, 63 MONTHS FROM THE FIRST OPERATION." (REF: FROM PAGE 8, 2ND PARAGRAPH OF THE PAPER). THE ABSTRACT AND PAPER INFORMATION IS INCLUDED BELOW: INFORMATION FROM A PUBLICATION: J CARDIOVASC SURG (TORINO). 2018 OCT; 59 (5): 746-752. DOI: 10.23736/S0021-9509.18.10204-7. EPUB 2018 MAY 22. TITLE: "MITROFLOW LXA STRUCTURAL DETERIORATION FOLLOWING AORTIC VALVE REPLACEMENT: A SINGLE-CENTER EXPERIENCE." AUTHORS: ZANNIS K, DIPLARIS K, MONIN JL, KHELIL N, DEBAUCHEZ M, DERVANIAN P, LANSAC E, CZIROM D, NOGHIN M, MANKOUBI L, AMABILE N. ABSTRACT: BACKGROUND: CONCERNS HAVE BEEN PREVIOUSLY RAISED REGARDING THE POTENTIAL EARLY DEGENERATION OF THE MITROFLOW (SORIN GROUP ITALIA, SALUGGIA, VERCELLI, ITALY) BIOPROSTHESES. WE AIMED TO EVALUATE OUR CLINICAL EXPERIENCE WITH THE MITROFLOW LXA PROSTHESIS FOR AORTIC VALVE REPLACEMENT. METHODS: WE PROSPECTIVELY ANALYZED DATA FROM 227 CONSECUTIVE PATIENTS (133 MALES, MEAN AGE 73.9±9.2 YEARS) IMPLANTED WITH THE MITROFLOW LXA BETWEEN FEBRUARY 2007 AND OCTOBER 2011. FOLLOW-UP DATA WERE OBTAINED BY CONTACTING THE REFERRING CARDIOLOGISTS. KAPLAN-MEIER CURVES WERE CONSTRUCTED FOR ALL-CAUSE MORTALITY, VALVE RELATED MORTALITY AND STRUCTURAL VALVE DEGENERATION (SVD). MULTIVARIABLE ANALYSIS WAS CONDUCTED TO IDENTIFY SVD PREDICTORS. RESULTS: MEDIAN FOLLOW-UP TIME WAS 54.2±37.9 MONTHS AND COMPLETENESS OF FOLLOW-UP WAS 95%. OVERALL MORTALITY IN THE ENTIRE SERIES WAS AT 31% (N.=71) AND MORTALITY FROM CARDIAC OR UNKNOWN CAUSES AT 20% (N.=46). SVD OCCURRED IN 24 PATIENTS (10%) (MEDIAN DELAY BETWEEN IMPLANTATION AND DIAGNOSIS: 62.6 (36.5) MONTHS). REINTERVENTION WAS REQUIRED IN 20 CASES (13 REDO SURGERY, 7 PERCUTANEOUS TRANSCATHETER VALVE INTERVENTION). THE 8 YEARS ACTUARIAL GLOBAL SURVIVAL WAS 54.7±4.9%, FREEDOM FROM VALVE RELATED MORTALITY 67.5±4.9% AND FREEDOM FROM SVD 72±8%. THE ESTIMATED FREEDOM FROM SVD WAS SIGNIFICANTLY (P=0.007) LONGER IN LARGER PROSTHESIS (DIAMETER >21 MM, 77±11%) COMPARED TO THE SMALLER DEVICES (=21 MM, 59±13%.). MULTIVARIATE ANALYSIS IDENTIFIED SMALLER PROSTHESES AND AGE AT IMPLANTATION AS INDEPENDENT PREDICTORS OF SVD. CONCLUSIONS: THE MITROFLOW LXA SHOWED EVIDENCE OF EARLY SVD IN THIS COHORT. A CLOSE FOLLOW-UP OF THESE PATIENTS IS STRONGLY ADVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235295 MITROFLOW LXA TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention