BEUDAMED
    FDA Adverse Event Other Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 1960278 · Received January 7, 2011

    Report

    Report Number
    3004478276-2011-00002
    Event Type
    Other
    Date Received
    January 7, 2011
    Date of Event
    December 9, 2010
    Report Date
    January 7, 2011
    Manufacturer
    SORIN GROUP CANADA INC. MITROFLOW DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVAL; AN EVAL SUMMARY WAS NOT AVAILABLE AT THE TIME OF THIS REPORT; HOWEVER INITIAL GROSS EXAMINATION OF THE DEVICE INDICATES THE PRESENCE OF CALCIFICATION. METHOD: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED. RESULTS: THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, DIMENSIONAL, AND PERFORMANCE REQUIREMENTS AT THE TIME OF MANUFACTURE AND RELEASE.

    Description of Event or Problem · 1

    THE COMPANY WAS NOTIFIED ON (B)(6) 2010, OF A MITROFLOW VALVE (MODEL LX, SIZE 21 MM, S/N (B)(4)) EXPLANTED ON (B)(6) 2010, REPORTEDLY DUE TO AORTIC STENOSIS. THE FIELD EXPERIENCE REPORT FORM SUBMITTED FOR THIS CASE INDICATES THAT THE HEALTH CARE PROFESSIONAL IS REPORTING THIS AS AN ADVERSE EVENT, BUT IS NOT EXPRESSING A CUSTOMER COMPLAINT. NO CLINICAL HISTORY FOR THE PT IS AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention