BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC SUPRA VALVE W/FLEXFIT

    MDR report key: 5628708 · Received May 3, 2016

    Report

    Report Number
    3001743903-2016-00031
    Event Type
    Injury
    Date Received
    May 3, 2016
    Date of Event
    March 25, 2016
    Report Date
    April 5, 2016
    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

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ALL ANALYSIS WAS BASED UPON THE ASSESSMENT OF THREE PHOTOGRAPHS OF THE EXPLANTED 19 MM SJM EPIC SUPRA BIOPROSTHESIS THAT WERE RECEIVED FROM THE FIELD AS PART OF THE COMPLAINT REPORTING. ONE OF THE RECEIVED PHOTOGRAPHS SHOWED THE OUTFLOW SIDE OF THE VALVE, AND TWO OF THE PHOTOGRAPHS SHOWED THE INFLOW SIDE OF THE VALVE. IN THE OUTFLOW PHOTO, WHAT APPEARED TO BE CIRCUMFERENTIAL WHITE TISSUE WAS OBSERVED EXTENDING OUT INTO THE INNER DIAMETER OF THE VALVE. THE WHITE TISSUE APPEARED TO EXTEND ONTO A PORTION OF THE PERICARDIAL STRIP, AND ONTO ONE OF THE STENT POSTS. BOTH OF THE PHOTOS OF THE INFLOW SIDE OF THE VALVE SHOWED WHAT APPEARED TO BE WHITE TISSUE COVERING THE BASE OF ONE OF THE CUSPS, WHICH APPEARED TO EXTEND ONTO A PORTION OF THE ANNULAR SUTURE LINE. DUE TO THE LIMITED VIEW OF THE DEVICE NO ADDITIONAL OBSERVATIONS WERE ABLE TO BE MADE. THE DEVICE HISTORY RECORD WAS REVIEWED, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A MITRAL VALVE REPLACEMENT WAS PERFORMED AND THIS 19MM SJM EPIC SUPRA VALVE WAS IMPLANTED IN A (B)(6) PATIENT WITH CONGENITAL SHONE'S COMPLEX. AT THE TIME OF IMPLANTATION, AN AORTIC VALVE WAS SELECTED FOR USE IN THE MITRAL POSITION. ON (B)(6) 2012, A POSTOPERATIVE CARDIAC CATHETERIZATION WAS PERFORMED WHICH FOUND THE PULMONARY ARTERIAL PRESSURE (PAP) WERE SYSTOLIC 41 MMHG, DIASTOLIC 15 MMHG AND MEAN 27 MMHG. THE PULSE WAVE VELOCITY (PWV) WAS 13 TO 15 M/S. IN (B)(6) 2013, AN ECHOCARDIOGRAM REVEALED TURBULENT FLOW AND MITRAL VALVE STENOSIS. ON (B)(6) 2015, A REPEAT CARDIAC CATHETERIZATION WAS PERFORMED AND PULMONARY PRESSURES WERE SYSTOLIC 83 MMHG, DIASTOLIC 30 MMHG AND MEAN 52 MMHG. THE PWV WAS 20 TO 29 M/S. SINCE 2014, THE PATIENT'S SYMPTOMS HAD SLIGHTLY WORSENED. THE MITRAL VALVE PEAK VELOCITY WAS 1.9 M/S POSTOPERATIVELY ON (B)(6) 2012, WITH AN INCREASE TO 2.9 M/S ON (B)(6) 2016. ON (B)(6) 2016, RE-DO MITRAL VALVE REPLACEMENT WAS PERFORMED. THE EPIC SUPRA VALVE WAS EXPLANTED AND UPON EXPLANT, FINDINGS INCLUDED WHAT APPEARED TO BE BIOLOGICAL TISSUE CONSISTENT WITH SIGNIFICANT PANNUS COVERING THE MAJORITY OF THE OUTFLOW SIDE AND CIRCUMFERENTIALLY EXTENDED FROM THE STENT BASE TOWARDS THE CUSPS. THE TISSUE CONTINUED ONTO THE STENT BASE OF THE INFLOW SIDE IN LIMITED APPEARANCE. THE TISSUE GROWTH APPARENTLY LIMITED CUSPAL MOBILITY. PER REPORT, NO PATHOLOGICAL EXAMINATION WAS CONDUCTED AT THE HOSPITAL. THERE WERE NO OTHER ISSUES OR CALCIFICATION OBSERVED ON THE CUSPS. THE VALVE IS NOT BEING RETURNED TO SJM; HOWEVER THE SURGEON PROVIDED PHOTOGRAPHS AND REQUESTED SJM INVESTIGATE THE ETIOLOGY OF THE CIRCUMFERENTIAL TISSUE BASED ON THE IMAGES THAT WERE PROVIDED. A 21MM SJM REGENT MECHANICAL HEART VALVE (SERIAL UNKNOWN) WAS IMPLANTED. PER REPORT, THE PHYSICIAN SELECTED THE REGENT AORTIC MECHANICAL VALVE FOR THE MITRAL POSITION AS IT HAS A LARGER EOA THAN OTHER SJM MITRAL VALVES. THE PATIENT WAS REPORTED TO BE STABLE POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280796 EPIC SUPRA VALVE W/FLEXFIT HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL BRASIL LTDA. ESP100-19 3677112

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| R