BEUDAMED
    FDA Adverse Event Death Summary report: N

    TORONTO STENTLESS PORCINE VALVE

    MDR report key: 316374 · Received February 20, 2001

    Report

    Report Number
    8020430-2001-00003
    Event Type
    Death
    Date Received
    February 20, 2001
    Date of Event
    January 30, 1998
    Report Date
    February 19, 2001
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PER DISCHARGE SUMMARY: IN 1998, THE PT WAS ADMITTED TO THE HOSP IN SUDDEN RESPIRATORY DISTRESS. SEVERAL DAYS PRIOR TO ADMISSION, THE PT EXPERIENCED FEVER, CHILLS, LOSS OF APPETITE AND GENERALIZED WEAKNESS. TEE SHOWED A "LARGE VEGETATION" ON THE AORTIC VALVE. BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS AND MULTIPLE OTHER POSTIVE BLOOD CULTURES, INCLUDING VANCOMYCIN RESISTANT ENTEROCOCCUS. HEAD CT SHOWED CVA OR SEPTIC EMBOLISM. THE PT ALSO DEVELOPED GANGRENE IN BOTH FEET. DESPITE AGGRESIVE ANTIBIOTIC TREATMENT, THE PT DETERIORATED AND EXPIRED 22 DAYS LATER IN 1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6447 TORONTO STENTLESS PORCINE VALVE TSPV LWR ST. JUDE MEDICAL, INC. SPA-101-22 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death