BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 5156038 · Received October 16, 2015

    Report

    Report Number
    3004478276-2015-00049
    Event Type
    Injury
    Date Received
    October 16, 2015
    Report Date
    September 24, 2015
    Manufacturer
    SORIN GROUP CANADA INC.
    Product Code
    DYE
    PMA / PMN Number
    P060038/S002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO FURTHER INFORMATION WAS PROVIDED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER NARRATIVE: THE COMPLETE MANUFACTURING AND MATERIAL RECORDS FOR THE MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LXA 23, S/N (B)(4) WERE PULLED AND REVIEWED BY QUALITY CONTROL AT LIVANOVA (B)(4). THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL AND PERFORMANCE STANDARDS REQUIRED FOR A LXA23 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURING AND RELEASE. NO FURTHER INFORMATION WAS PROVIDED. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2015 THAT MITROFLOW VALVE (LXA SIZE23) NEEDS TO BE REPLACEMENT AFTER 2 YEARS AND 9 MONTHS. NO INFORMATION WAS PROVIDED REGARDING THE RE-OPERATION DATE OR WHEN THE VALVE WILL BE EXPLANTED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686138 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE HEART VALVE DYE SORIN GROUP CANADA INC. LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention