BEUDAMED
    FDA Adverse Event Other Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 2170163 · Received June 24, 2011

    Report

    Report Number
    3004478276-2011-00008
    Event Type
    Other
    Date Received
    June 24, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 24, 2011
    Manufacturer
    SORIN GROUP CANADA INC. MITROFLOW DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER. THE DEVICE WAS RECEIVED ON (B)(4) 2011, BUT AN EVALUATION SUMMARY IS NOT AVAILABLE AT THIS TIME. GROSS EXAMINATION AND X-RAY ANALYSIS CONFIRMED THE PRESENCE OF LEAFLET CALCIFICATION. FULL MORPHO-HISTOLOGICAL ANALYSIS IS IN PROGRESS. METHOD: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED. RESULTS: THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, DIMENSIONAL, AND PERFORMANCE REQUIREMENTS AT THE TIME OF MANUFACTURE AND RELEASE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4), (B)(4) DIVISION WAS NOTIFIED ON (B)(4) 2011 OF A MITROFLOW VALVE (MODEL 12A, SIZE 21 MM, S/N/ (B)(4)) THAT WAS EXPLANTED ON (B)(6) 2011 FOR REPORTED PREMATURE STRUCTURAL VALVE DETERIORATION. REPORTEDLY, THE PATIENT DID WELL AFTER IMPLANTATION AND YEARLY ECHOCARDIOGRAPHY EXAMINATIONS SHOWED NO EARLY SIGNS OF GRADIENT INCREASES UNTIL (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE, HEART VALVE LWR SORIN GROUP CANADA INC. MITROFLOW DIVISION 12A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention