BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA STENTED TISSUE VALVE

    MDR report key: 11961936 · Received June 8, 2021

    Report

    Report Number
    3014918977-2021-00011
    Event Type
    Injury
    Date Received
    June 8, 2021
    Report Date
    June 16, 2021
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    LWR
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE SERIOUS INJURIES OCCURRED, INCLUDING ATELECTASIS/ LUNG COLLAPSE, RENAL FAILURE, ADVERSE NEUROLOGICAL EVENT, RE-EXPLORATION DUE TO BLEEDING, ENDOCARDITIS, STRUCTURAL VALVE DEGENERATION, MODERATE PATIENT-PROSTHESIS MISMATCH(PPM) AND RE-OPERATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    RELATED MANUFACTURING REFERENCE NUMBER: 3014918977-2021-00010. THE ARTICLE, "MID-TERM CLINICAL AND HEALTH-RELATED QUALITY OF LIFE OUTCOMES FOR THE TRIFECTA BIOPROSTHESIS", WAS REVIEWED. THIS RESEARCH ARTICLE IS A PROSPECTIVE SINGLE CENTER EXPERIENCE TO ASSESS THE FUNCTIONAL AND CLINICAL OUTCOME OF THE TRIFECTA VALVE AT MID-TERM FOLLOW-UP. TRIFECTA VALVE WAS ASSOCIATED WITH THE STUDY. THE ARTICLE CONCLUDED THAT THE TRIFECTA VALVE, IN PATIENTS WITH A MEAN AGE OF 65 YEARS, PROVIDES SATISFACTORY HEMODYNAMICS, SURVIVAL AND FREEDOM FROM RE-OPERATION AT MID-TERM FOLLOW-UP. THE PRIMARY AUTHOR OF THE ARTICLE IS BISWARUP PURKAYASTHA, DEPARTMENT OF CARDIAC SURGERY, NH RABINDRANATH TAGORE INTERNATIONAL INSTITUTE OF CARDIAC SCIENCES, 124, EM BYPASS, MUKUNDAPUR, KOLKATA 700099, INDIA. THE CORRESPONDENCE AUTHOR OF THE ARTICLE IS PRADEEP NARAYAN, DEPARTMENT OF CARDIAC SURGERY, NH RABINDRANATH TAGORE INTERNATIONAL INSTITUTE OF CARDIAC SCIENCES, 124, EM BYPASS, MUKUNDAPUR, KOLKATA 700099, INDIA WITH THE CORRESPONDING EMAIL: [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851784 TRIFECTA STENTED TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, COSTA RICA LTDA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention