BEUDAMED
    FDA Adverse Event Other Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 2904623 · Received January 3, 2013

    Report

    Report Number
    3004478276-2012-00013
    Event Type
    Other
    Date Received
    January 3, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 31, 2012
    Manufacturer
    SORIN GROUP CANADA INC. MITROFLOW DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, METHOD: THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW ARE IN PROGRESS. RESULTS: NO DEFINITIVE RESULTS AT THIS TIME. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN AT THIS TIME AS DEVICE IS NOT AVAILABLE FOR EVALUATION AND PATIENT HISTORY WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED OF A MITROFLOW VALVE THAT WAS EXPLANTED AFTER 1.9 YEARS DUE TO A HIGH GRADIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3613 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE, HEART VALVE LWR SORIN GROUP CANADA INC. MITROFLOW DIVISION LXA21

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention