BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA PULMONARY VALVED CONDUIT

    MDR report key: 1000967 · Received February 15, 2008

    Report

    Report Number
    2025587-2008-00007
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    January 15, 2008
    Report Date
    January 18, 2008
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT HAS NOT BEEN DETERMINED. NO DEFINITIVE CONCLUSION CAN BE DRAWN AT THIS TIME REGARDING THE PERFORMANCE OF THE DEVICE. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. TO DATE, THE ANALYSIS HAS NOT BEEN COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED FOR ANALYSIS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS PATIENT UNDERWENT SCHEDULED INITIAL REPAIR FOR TETRALOGY OF FALLOT. PATIENT SUFFERED FROM MAPCAS, HYPOPLASTIC LEFT PULMONARY ARTERY / RIGHT PULMONARY ARTERY AND RIGHT AORTIC ARCH. IN A PREVIOUS SURGERY, A BLALOG-TAUSSIG SHUNT (CONNECTING AORTA AND PULMONARY ARTERY, TEMPORARY SOLUTION TO IMPROVE CHILD'S OXYGEN SATURATION) WAS PLACED AND THE MAPCAS WERE OCCLUDED. NORMAL UNEVENTFUL POST-OPERATIVE COURSE, DISCHARGE WITH TRANSCONDUIT GRADIENT OF 34 MMHG, NO INSUFFICIENCY. ACTUAL CATHETERIZATION REVEALED RESIDUAL VENTRICULAR/SEPTAL DEFECT, WITH DISTAL ANASTOMOSIS STENOSIS INCLUDING THE HYPOPLASTIC RPA AND LPA. THE DEVICE WAS EXPLANTED IN TOTO, AND PANNUS OVERGROWTH WAS OBSERVED AT THE DISTAL ANASTOMOSIS. EVENT CLASSIFIED AS NON-STRUCTURAL DYSFUNCTION. OTHERWISE CONDUIT WAS NORMAL, WITH SOFT LEAFLETS.

    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 11 MO Required Intervention