BEUDAMED
    FDA Adverse Event Other Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 2682639 · Received July 27, 2012

    Report

    Report Number
    3004478276-2012-00006
    Event Type
    Other
    Date Received
    July 27, 2012
    Date of Event
    June 29, 2012
    Report Date
    July 27, 2012
    Manufacturer
    SORIN GROUP CANADA INC., MITROFLOW DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER. THE DEVICE WAS RECEIVED ON 07/25/2012, BUT AN EVALUATION SUMMARY IS NOT AVAILABLE AT THIS TIME. METHOD - 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. RESULTS - NO DEFINITIVE RESULTS AT THIS TIME. CONCLUSIONS - NO CONCLUSION CAN BE DRAWN AT THIS TIME AS DEVICE EVALUATION, INCLUDING HISTOPATHOLOGY, IS IN PROGRESS. CORRESPONDENCE FROM FDA ON REPORT (B)(4) (DATED 07/17/2012) WAS RECEIVED BY THE COMPANY ON 07/26/2012.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) OF A MITROFLOW VALVE (MODEL LXA, SIZE 23MM, SN (B)(4)) THAT WAS EXPLANTED ON (B)(6) 2012, AFTER APPROXIMATELY 2.8 YEARS, FOR REPORTED BIOPROSTHETIC STENOSIS DUE TO STRUCTURAL VALVE DETERIORATION RESULTING FROM CALCIFICATION.

    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 LXA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention