BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA¿ VALVE

    MDR report key: 4061742 · Received September 4, 2014

    Report

    Report Number
    3008452825-2014-00034
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 2014
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    LWR
    PMA / PMN Number
    PP100029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THIS INVESTIGATION CONCLUDED THE PRESENCE OF FIBROUS THICKENING ON ALL CUSPS, FIBROUS PANNUS INGROWTH ON INFLOW SURFACE OF CUSP 1, A THIN LAYER OF FIBRIN ON ALL CUSPS, AND TEARS ON CUSPS 2 AND 3. SPECIAL STAINS WERE NEGATIVE FOR ORGANISMS, AND NO ACUTE INFLAMMATION OR SIGNIFICANT CALCIFICATIONS WERE PRESENT. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE CAUSE OF FIBRIN, PANNUS, AND TEAR WERE DUE TO AN INTRINSIC DEFECT IN THE VALVE, AS SUPPORTED BY REVIEW OF THE VALVE'S DEVICE HISTORY RECORD AND THE ANALYSIS PERFORMED. THE CAUSE OF THE FIBRIN, PANNUS, AND TEAR REMAINS UNKNOWN.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED THE PATIENT UNDERWENT A DOUBLE VALVE REPLACEMENT PROCEDURE ON (B)(6) 2012. THIS 21 MM SJM TRIFECTA¿ VALVE WAS IMPLANTED IN THE AORTIC POSITION AND A 29 MM SJM EPIC¿ STENTED TISSUE VALVE WAS IMPLANTED IN THE MITRAL POSITION. POSTOPERATIVE COURSE WAS CHARACTERIZED BY IMPLANT OF AN SJM ACCENT PACEMAKER. ON (B)(6) 2014, THE PATIENT PRESENTED TO THE HOSPITAL WITH DYSPNEA, WAS TREATED WITH DIURETIC THERAPY, AND WAS DISCHARGED. THE PATIENT PRESENTED TO THE HOSPITAL AGAIN ON (B)(6) 2014 WITH SEVERE PULMONARY EDEMA AND WAS HOSPITALIZED. TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED AORTIC INSUFFICIENCY DUE TO IMPROPER COAPTATION OF THE LEFT CORONARY CUSP. THE MITRAL VALVE ALSO SHOWED TRANSVALVULAR MITRAL INSUFFICIENCY. THE PATIENT UNDERWENT A RE-DO DOUBLE VALVE REPLACEMENT PROCEDURE ON (B)(6) 2014. DURING THE EXPLANT PROCEDURE, THE CUSP CORRESPONDING TO THE LEFT CORONARY SINUS OF THIS AORTIC TRIFECTA¿ VALVE WAS FOUND TO BE DETACHED NEAR THE ANNULUS. ONE CUSP OF THE MITRAL EPIC¿ STENTED TISSUE VALVE (MEDWATCH REPORT# 3001883144-2014-00018) WAS FOUND TO BE PROLAPSED. A 27 MM BIOPROSTHETIC VALVE FROM ANOTHER MANUFACTURER WAS IMPLANTED IN THE MITRAL POSITION AND A 21 MM BIOPROSTHETIC VALVE FROM ANOTHER MANUFACTURER WAS IMPLANTED IN THE AORTIC POSITION. THE PATIENT WAS REPORTED TO BE STABLE POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542629 TRIFECTA¿ VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, COSTA RICA LTDA TF-21A 3676316

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R