BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM

    MDR report key: 7866518 · Received September 11, 2018

    Report

    Report Number
    3001883144-2018-00079
    Event Type
    Injury
    Date Received
    September 11, 2018
    Report Date
    September 11, 2018
    Manufacturer
    ST. JUDE MEDICAL, BRASIL LTDA.
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENTS OF ENDOCARDITIS AND LEAFLET PROLAPSE WERE REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION COMES FROM THE ABSTRACT OF THE "(B)(6) JOURNAL OF CARDIOVASCULAR SURGERY" 2018, VOL.47, NO.4, P.162-165. TITLE: EMERGENCY SURGICAL TREATMENT FOR FUNGAL PROSTHETIC VALVE ENDOCARDITIS DUE TO GIANT VEGETATION. ON AN UNKNOWN DATE IN 2008, THE PATIENT WAS DIAGNOSED WITH CHRONIC HEART FAILURE (CHF). ON AN UNKNOWN DATE IN 2012, A MITRAL VALVE REPLACEMENT (MVR), TRICUSPID ANNULOPLASTY (TAP) AND MAZE PROCEDURE WERE PERFORMED. THIS 31MM EPIC VALVE WAS IMPLANTED IN THE PATIENT'S MITRAL POSITION AND A 34MM EDWARDS MC3 TRICUSPID ANNULOPLASTY RING IN THE TRICUSPID POSITION. IN THE BEGINNING OF (B)(6) 2014, THE PATIENT EXPERIENCED GENERAL FATIGUE AND LOSS OF APPETITE. LATER, THE PATIENT PRESENTED AT THE HOSPITAL WITH A HIGH FEVER OF 39.0 DEGREES CELSIUS. A CHEST RADIOGRAPHY REVEALED CARDIOTHORACIC RATIO (CTR) OF 60 PERCENT, BILATERAL PLEURAL EFFUSIONS AND SIGNIFICANT PULMONARY CONGESTION. CANDIDA GRABLATA WAS DETECTED BY BLOOD CULTURE. A TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) WAS PERFORMED AND LARGE VEGETATIONS WERE ATTACHED TO BOTH ANTERIOR AND POSTERIOR LEAFLETS ON MULTIPLE SITES OF THE 31MM EPIC VALVE, WHICH WERE FLOATING AND HAD A MAXIMUM DIAMETER OF 20 MM. THE PATIENT'S CARDIAC FUNCTION WAS NORMAL AT THIS TIME; HOWEVER, MITRAL REGURGITATION (MR) WAS CONFIRMED. DUE TO THE HIGH POSSIBILITY OF LEAFLET PROLAPSE AND PROSTHETIC VALVE ENDOCARDITIS (PVE) DUE TO FUNGAL INFECTION AN EMERGENCY SURGERY WAS PERFORMED. UPON EXPLANT OF THE 31MM EPIC VALVE, LARGE AND MULTIPLE VEGETATIONS WERE ADHERED ON THE VALVE AND THE LEAFLETS HAD BECOME DISRUPTED AND MOSTLY PROLAPSED. NO ABSCESS WAS OBSERVED ON THE PATIENT'S NATIVE MITRAL ANNULUS. A 31MM CARBOMEDICS VALVE (SORIN) WAS IMPLANTED WITHIN THE MITRAL POSITION. NO ANOMALIES WERE NOTED ON THE PATIENT'S NATIVE AORTIC VALVE. AFTER EXPLANT, FIBRIN AND INFLAMMATORY CELLS WERE REPORTED TO BE INFILTRATED OVER THIS VALVE ON PATHOLOGY FINDINGS. THE LEAFLETS AND WALL STRUCTURE OF THIS VALVE WERE ALSO DAMAGED. THE CANDIDA GRABLATA WAS CONFIRMED AGAIN BY THE POSTOPERATIVE BLOOD CULTURE AND CONCLUSIVELY DIAGNOSED AS FUNGAL PVE. POSTOPERATIVELY, ANTIBIOTIC THERAPY STARTED AND AMPHOTERICIN B LIPOSOME WAS ADMINISTERED. ON THE 35TH OPERATIVE DAY, INFECTIVE ENDOCARDITIS (IE) TURNED NEGATIVE FROM THE BLOOD CULTURE. ON THE 42ND OPERATIVE DAY, ANTIBIOTIC THERAPY WAS STOPPED. ON THE 50TH OPERATIVE DAY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON FOOT. PATIENT SPECIFIC INFORMATION OF PATIENT IDENTIFIER AND BIRTHDATE ARE NOT AVAILABLE FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708259 EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, BRASIL LTDA. E100-31M

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R