BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 4090626 · Received September 15, 2014

    Report

    Report Number
    3004478276-2014-00017
    Event Type
    Death
    Date Received
    September 15, 2014
    Report Date
    September 12, 2014
    Manufacturer
    SORIN GROUP CANADA
    Product Code
    DYE
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DETAILS REGARDING THE DEVICE, THE PATIENT OR THE PATIENT'S CLINICAL HISTORY WERE PROVIDED IN THE INITIAL NOTIFICATION. AS REPORTED, THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. SUBSEQUENT FOLLOW-UPS BY THE LOCAL SORIN SALES REPRESENTATIVE, WERE UNSUCCESSFUL IN OBTAINING ADDITIONAL INFORMATION ABOUT THE CASE. A REVIEW OF THE MANUFACTURING AND MATERIAL RECORDS FOR THE SUBJECT VALVE COULD NOT BE CONDUCTED BECAUSE THE DEVICE SERIAL NUMBER WAS NOT PROVIDED. AT THIS TIME, WE ARE CLOSING THIS CASE AS THERE IS NO FURTHER ACTION THAT THE COMPANY CAN TAKE WITH THE AVAILABLE INFORMATION AND LACK OF THE VALVE TO ANALYZE. IF AT SUCH TIME ADDITIONAL INFORMATION ON THE DEVICE (MODEL/SIZE AND/OR THE SERIAL NUMBER) OR SOME CLINICAL DETAILS ON THE PATIENT ARE PROVIDED, WE WOULD BE HAPPY TO RE-VISIT THE CASE. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR. DEVICE STILL NOT RETURNED TO MFR. NO INFO ABOUT DEVICE WAS PROVIDED. NO DEFINITIVE RESULTS AT THIS TIME. NO CONCLUSION CAN BE DRAWN AT THIS TIME AS THE DEVICE WAS NOT YET RETURNED TO THE MFR.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED OF A MITROFLOW VALVE (MODEL AND SIZE UNKNOWN) THAT THE PATIENT EXPIRED AND THE VALVE WAS EXPLANTED DURING THE AUTOPSY. NO PATIENT CLINICAL HISTORY, DEVICE SERIAL NUMBER AND MODEL NUMBER WERE PROVIDED BY THE HOSPITAL. THE VALVE WILL NOT BE RETURNED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE MFR WAS NOTIFIED OF A MITROFLOW VALVE (MODEL AND SIZE UNK) THAT THE PT EXPIRED AND THE VALVE WAS EXPLANTED DURING THE AUTOPSY. NO PT CLINICAL HISTORY, DEVICE SERIAL NUMBER AND MODEL NUMBER WERE PROVIDED BY THE HOSP. IT IS STILL UNK IF THE VALVE WILL BE RETURNED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570413 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE, HEART VALVE DYE SORIN GROUP CANADA LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death