BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA STENTED TISSUE VALVE, IDE

    MDR report key: 3883720 · Received June 6, 2014

    Report

    Report Number
    8020430-2014-00002
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ST. JUDE MEDICAL CANADA
    Product Code
    LWR
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED A 21MM TRIFECTA VALVE WAS IMPLANTED. THE PT PRESENTED WITH SHORTNESS OF BREATH, ACHALASIA AND FAILURE TO THRIVE. EXTREME WEIGHT LOSS WAS REPORTED OVER SEVERAL MONTHS REQUIRING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT FOR NUTRITION. AN ECHOCARDIOGRAM SHOWED LEAKAGE AND PROSTHETIC VALVE STENOSIS AND GRADIENTS WERE ELEVATED. A VALVE-IN-VALVE REPLACEMENT PROCEDURE WAS SUGGESTED BUT HAS BEEN DELAYED. THE PT WAS DISCHARGED AND WILL BE RE-EVALUATED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331142 TRIFECTA STENTED TISSUE VALVE, IDE STENTED TISSUE VALVE LWR ST. JUDE MEDICAL CANADA TF-21A-IDE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R