BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 4252358 · Received November 14, 2014

    Report

    Report Number
    3004478276-2014-00062
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    May 1, 2014
    Report Date
    November 14, 2014
    Manufacturer
    SORIN GROUP CANADA INC.
    Product Code
    DYE
    PMA / PMN Number
    P060038/S002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE DEVICE WAS NOT RETURNED, SORIN GROUP'S INVESTIGATION WAS LIMITED TO A REVIEW OF THE DEVICE HISTORY RECORDS. THE COMPLETE MANUFACTURING AND MATERIAL RECORDS FOR THE SUBJECT VALVE WERE PULLED AND REVIEWED BY QUALITY CONTROL AT SORIN GROUP (B)(4). THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A LXA19 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE.

    Additional Manufacturer Narrative · 1

    RESULTS = THE COMPLETE MANUFACTURING AND MATERIAL RECORDS FOR THE SUBJECT VALVE WERE PULLED AND REVIEWED BY QUALITY CONTROL AT SORIN GROUP (B)(4). THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A LXA19 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. SORIN IS STILL CONFIRMING FROM THE HOSPITAL IF DEVICE WILL BE AVAILABLE FOR EVALUATION. HISTOPATHOLOGICAL EXAMINATION WILL BE CONDUCTED, IF VALVE IS RETURNED.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2014 THAT MITROFLOW VALVE (LXA SIZE19) WAS EXPLANTED AFTER 3.2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736963 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE, HEART VALVE DYE SORIN GROUP CANADA INC. LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention