BEUDAMED
    FDA Adverse Event Summary report: N

    PERIMOUNT MAGNA PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMA

    MDR report key: 1081377 · Received July 7, 2008

    Report

    Report Number
    1081377
    Date Received
    July 7, 2008
    Date of Event
    December 14, 2007
    Report Date
    April 1, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, LLC
    Product Code
    LWR
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    PT HAD ELECTIVE VALVE REPLACEMENT SURGERY IN LATE 2007. PT DID REQUIRE SEVERAL BLOOD TRANSFUSIONS POST-OP. PER MD, PATIENT HAD LOW-GRADE FEVERS AND ELEVATED WBC DURING INITIAL STAY WHICH RESOLVED - CAUSE NOT IDENTIFIED. PT WAS READMITTED 15 DAYS LATER WITH STAPH AUREUS STERNAL WOUND INFECTION AND ENDOCARDITIS. RETURN TO OR SEVERAL TIMES FOR DEBRIDEMENT. EXPIRED APPROXIMATELY A MONTH AFTER THE ORIGINAL SURGERY AS A RESULT OF THIS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIMOUNT MAGNA PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMA HEART VALVE, AORTIC, PORCINE LWR EDWARDS LIFESCIENCES, LLC 3000TFX 21MM N/A
    2 MEDTRONICS CG FUTURE ANNULOPLASTY RING, COMPOSITE KRH MEDTRONIC CARDIAC SURGICAL PRODUCTS DIVISION 638RL28 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR