BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 4329720 · Received August 19, 2014

    Report

    Report Number
    3004478276-2014-00036
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    July 2, 2014
    Manufacturer
    SORIN GROUP CANADA
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATHOLOGY ANALYSIS ON THE VALVE IS STILL ONGOING. NO FINAL EVALUATION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2014 THAT A MITROFLOW VALVE MODEL LXA SIZE 25 WAS EXPLANTED IN A JUVENILE PATIENT AFTER 1.5 YEARS DUE TO REGURGITATION. THE MITROFLOW AORTIC VALVE WAS EXPLANTED FROM THE PULMONARY POSITION. IT WAS ALSO NOTIFIED THAT DURING THE SAME SURGERY ANOTHER MITROFLOW VALVE MODEL LXA SIZE 23 IMPLANTED IN THE AORTIC POSITION WAS EXPLANTED DUE TO AORTIC STENOSIS ( THE MANUFACTURER SUBMITTED AND MDD ALSO FOR THIS EVENT 3004478276-2014-00035).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496673 MITROFLOW AORTIC PERICARDIAL HEART VALVE MITROFLOW LWR SORIN GROUP CANADA LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Hospitalization| R