BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 2093562 · Received May 11, 2011

    Report

    Report Number
    3004478276-2011-00006
    Event Type
    Death
    Date Received
    May 11, 2011
    Date of Event
    December 23, 2010
    Report Date
    May 11, 2011
    Manufacturer
    SORIN GROUP CANADA INC., MITROFLOW DIV.
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ECHOCARDIOGRAPHY VIDEOS HAVE BEEN RECEIVED FROM THE HOSPITAL AND ARE BEING SENT TO AN EXTERNAL CONSULTANT FOR EVALUATION. ACCORDING TO THE FIELD EXPERIENCE REPORT FORM, THE SURGEON NOTED THAT IT WILL BE DIFFICULT TO INVESTIGATE THIS CASE WITHOUT THE DEVICE. REPORTEDLY THE FAMILY DID NOT AGREE TO AN AUTOPSY IN ORDER TO RETRIEVE THE VALVE. EVALUATION: 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

    SORIN GROUP (B)(4) INC., MITROFLOW DIVISION WAS NOTIFIED ON (B)(6) 2011 OF A MITROFLOW VALVE (MODEL LXA, SIZE 21 MM, S/N (B)(4)) THAT WAS IMPLANTED ON (B)(6) 2010 AND REPORTEDLY DEVELOPED A THROMBUS APPROXIMATELY 3 WEEKS LATER, CREATING AORTIC STENOSIS. TWO OF THREE LEAFLETS WERE INDICATED TO BE RESTRICTED. THE FIELD EXPERIENCE REPORT FORM INDICATES THAT THE PT LATER DIED, BUT A SPECIFIC DATE WAS NOT INDICATED. THE SURGEON IS NOT EXPRESSING A COMPLAINT REGARDING THE QUALITY AND/OR PERFORMANCE OF THIS VALVE.

    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 DIV. LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death| H