BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEV TRI BR 2-0 C-2 30"X9 PFM

    MDR report key: 365489 · Received December 11, 2001

    Report

    Report Number
    1221601-2001-00004
    Event Type
    Other
    Date Received
    December 11, 2001
    Date of Event
    November 21, 2001
    Report Date
    December 11, 2001
    Manufacturer
    GENZYME BIOSURGERY A DIV OF GER
    Product Code
    GAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2001 THE PT UNDERWENT AN "AVR" WITH #23 TOP HAT CARBOMEDICS VALVE, MVR WITH #33 ST. JUDE MECHANICAL PROSTHESIS AND CABG X4. THE NEXTSTITCH SUTURE TECHNIQUE WAS UTILIZED ON THE MITRAL VALVE. THE PT'S POST-OPERATIVE COURSE HAS BEEN COMPLICATED BY PROLONGED VENTILATION DUE TO PULMONARY EDEMA. DEEP VEIN THROMBOSIS, LEFT LEG, THE DIAGNOSIS OF DEEP VEIN THROMBOSIS WAS MADE 8 DAYS LATER AND THE PT WAS PLACED ON COUMADIN THE FOLLOWING DAY. THE PT HAS BEEN TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS WITH NO CLEAR SOURCE OF INFECTION IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55827 TEV TRI BR 2-0 C-2 30"X9 PFM NON-ABSORBABLE SUTURE GAT GENZYME BIOSURGERY A DIV OF GER G7-100C9 454680

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization