BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM

    MDR report key: 6854655 · Received September 11, 2017

    Report

    Report Number
    3008452825-2017-00208
    Event Type
    Injury
    Date Received
    September 11, 2017
    Report Date
    September 11, 2017
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA (CVD)
    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

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE SERIAL NUMBER WAS UNAVAILABLE. 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 JA CLINICAL REPORTS 2017, VOL.3, NO.15, DOI 10.1186/S40981-017-0086-5, TITLED UNEXPECTED BIOPROSTHETIC MITRAL VALVE THROMBUS DURING LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION. THE AUTHORS PRESENT A CASE OF SEVERE MITRAL STENOSIS DUE TO BIOPROSTHETIC VALVE THROMBUS. THE PATIENT WAS DIAGNOSED WITH DILATED-PHASE HYPERTROPHIC CARDIOMYOPATHY AND UNDERWENT MITRAL VALVE REPLACEMENT. THE PATIENT REQUIRED VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) DUE TO EXTREMELY LOW CARDIAC OUTPUT AND WAS SCHEDULED FOR LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION. TRANSESOPHAGEAL ECHOCARDIOGRAPHIC EXAMINATION BEFORE LVAD IMPLANTATION REVEALED SEVERE MITRAL STENOSIS DUE TO BIOPROSTHETIC MITRAL VALVE THROMBUS, WHICH WAS NOT DETECTED BY TRANSTHORACIC ECHOCARDIOGRAPHY IN THE INTENSIVE CARE UNIT AND CONTRIBUTED TO THE LOW CARDIAC FUNCTION. THE THROMBUS WAS REMOVED THROUGH AN UNSCHEDULED LEFT ATRIOTOMY BEFORE LVAD IMPLANTATION. THE POSSIBILITY OF BIOPROSTHETIC VALVE THROMBOSIS MUST BE CONSIDERED WHEN THE PATIENT IS DEPENDENT ON VA-ECMO SUPPORT. EARLY TRANSESOPHAGEAL ECHOCARDIOGRAPHIC EXAMINATION OF THE BIOPROSTHETIC VALVE MAY BE HELPFUL AND CONTRIBUTE TO SURGICAL DECISION-MAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635640 EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, COSTA RICA LTDA (CVD) E100-27M

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R