BEUDAMED
    FDA Adverse Event Other Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 2379122 · Received December 8, 2011

    Report

    Report Number
    3004478276-2011-00013
    Event Type
    Other
    Date Received
    December 8, 2011
    Date of Event
    November 6, 2011
    Report Date
    December 8, 2011
    Manufacturer
    SORIN GROUP CANADA INC. MITROFLOW DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED ON (B)(6) 2011, BUT AN EVALUATION SUMMARY IS NOT AVAILABLE AT THIS TIME. GROSS EXAMINATION INDICATED LEAFLET CALCIFICATION AND PANNUS FORMATION ON THE SEWING RING AND LEAFLETS. X-RAY ANALYSIS CONFIRMED THE PRESENCE OF CALCIFICATION. FULL MORPHO-HISTOLOGICAL ANALYSIS IS IN PROGRESS. METHOD - A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED. RESULT - THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, DIMENSIONAL, AND PERFORMANCE REQUIREMENTS AT THE TIME OF MFR AND RELEASE. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME AS DEVICE EVAL, INCLUDING HISTOPATHOLOGY, IS IN PROGRESS.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) INC., MITROFLOW DIVISION WAS NOTIFIED ON (B)(6) 2011 OF A MITROFLOW VALVE (MODEL 12A27; S/N (B)(4)) THAT WAS EXPLANTED ON (B)(6) 2011 FOR REPORTED CENTRAL AORTIC REGURGITATION. THE VALVE WAS IMPLANTED ON (B)(6) 2004 AS PART OF THE (B)(6) STUDY. AS REPORTED, THE MITROFLOW VALVE WAS EXPLANTED AND WAS REPLACED WITH AN EDWARDS LIFESCIENCES MAGNA EASE BIOPROSTHETIC AORTIC VALVE, SIZE 29 MM. REPORTEDLY, THE PT EXPERIENCED A POST-OPERATIVE CARDIO-EMBOLIC INDUCED CVA ON (B)(6) 2011. ACCORDING TO THE FIELD EXPERIENCE REPORT FORM, THE ATTENDING SURGEON IS NOT EXPRESSING A COMPLAINT WITH THE QUALITY AND/OR PERFORMANCE OF THE MITROFLOW VALVE. THE EVENT WAS REPORTED TO THE COMPANY AS PART OF THE ONGOING MITROFLOW LONG-TERM CLINICAL STUDY.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention