BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA PULMONARY VALVED CONDUIT

    MDR report key: 1070929 · Received July 8, 2008

    Report

    Report Number
    2025587-2008-00054
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    May 9, 2008
    Report Date
    July 2, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: UPON RECEIPT, A 2.2CM SECTION OF THE VALVE CONDUIT WAS CONTAINED IN A CLEAR, 0.2% GLUTARALDEHYDE SOLUTION. VISUAL INSPECTION OF THE LEAFLETS REVEALED THEY WERE FLEXIBLE. FURTHER INSPECTION NOTED GLISTENING OFF-WHITE PANNUS THAT THINLY LINED THE INNER WALL OF THE CONDUIT. A THICKER SECTION WAS NOTED THROUGH THE INFLOW AND OUTFLOW ORIFICES. AN UNK AMOUNT OF PANNUS AROUND THE INFLOW AND OUTFLOW ORIFICES MAY HAVE BEEN REMOVED DURING EXPLANT. A RADIOGRAPH REVEALED MODERATE MINERALIZATION IN THE HOST TISSUE AND CONDUIT WALL ADJACENT TO THE INFLOW ORIFICE. CONCLUSION: REDUCED PERFORMANCE OF THE DEVICE DUE TO HOST TISSUE OVERGROWTH AND MINERALIZATION, CONDITIONS GENERALLY ATTRIBUTED TO THE PT. THE PRODUCT WAS EXPLANTED AND REPLACED WITH NO REPORTED ADVERSE PT OUTCOMES.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT APPROX THREE YRS POST IMPLANT, ECHOCARDIOGRAPHIC AND CATHETER IMAGING OF THIS BIOPROSTHETIC PULMONARY VALVE REVEALED CENTRAL REGURGITATION AND DILATATION, DUE TO PULMONARY ARTERY STENOSIS (UNIFOCALIZED MARCAS). THE VALVE WAS REMOVED, REPLACED, AND RETURNED FOR ANALYSIS. THE PHYSICIAN DID NOT EXPRESS DISSATISFACTION WITH THE PERFORMANCE OF THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTEGRA PULMONARY VALVED CONDUIT MWH MEDTRONIC HEART VALVES, INC. 200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R