BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 6094932 · Received November 10, 2016

    Report

    Report Number
    3004478276-2016-00148
    Event Type
    Death
    Date Received
    November 10, 2016
    Report Date
    April 9, 2017
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    DYE
    PMA / PMN Number
    P060038/S026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2016 ABOUT A PUBLICATION WHICH EXCERPTS FROM THE ARTICLE WRITTEN BY: LOUREIRO-AMIGO J, ET AL. - PROSTHETIC VALVE WITH INFECTIVE ENDOCARDITIS CAUSED BY PROPIONIBACTERIUM AVIDUM. A CASE REPORT. ENFERM INFECC MICROBIOL CLIN. 2016. HTTP://DX.DOI.ORG/10.1016/J.EIMC.2016.08.010. THE CASE OF AN (B)(6) WOMAN WITH A HISTORY OF HYPERTENSION, DIABETES MELLITUS AND PERMANENT PACEMAKER IMPLANTATION, WHO UNDERWENT BIOPROSTHETIC AORTIC VALVE REPLACEMENT (CROWN PRT 19 MM) DUE TO AORTIC STENOSIS. EIGHT MONTHS LATER THE PATIENT PRESENTED AT THE EMERGENCY ROOM WITH FATIGUE, MALAISE AND WEIGHT LOSS OVER A PERIOD OF 8 WEEKS. ELECTROCARDIOGRAM SHOWED A COMPLETE ATRIOVENTRICULAR BLOCK WITH NORMAL PACEMAKER STIMULATION. TWO SETS OF BLOOD CULTURES WERE OBTAINED. THE PATIENT WAS ADMITTED WITH A DIAGNOSIS OF VIRAL RESPIRATORY INFECTION AND CONGESTIVE HEART FAILURE. ANTIBIOTIC THERAPY WAS NOT INITIATED. TWENTY-FOUR HOURS AFTER ADMISSION SHE PRESENTED AVENTRICULAR TACHYCARDIA WITHOUT PULSE REQUIRING ELECTRIC CARDIOVERSION. A TRANSTHORACIC ECHOCARDIOGRAM SHOWED A SEVERE PROSTHETIC AORTIC VALVE STENOSIS WITH CALCIFIED UNSTRUCTURED LEAFLETS AND THICKENED CALCIFIED MITRAL LEAFLETS, WITHOUT IMAGES OF VEGETATIONS. ON DAY 3, CORYNEFORM GRAM-POSITIVE BACILLI GREW IN ANAEROBIC BOTTLES OF BLOOD CULTURES COLLECTED AT ADMISSION (AFTER 65 H OF CULTURE).THIS RESULT WAS INITIALLY REGARDED AS A CONTAMINATION AND WAS NOT REPORTED TO CLINICIANS TILL THE NEXT DAY WHEN THE MICROBIOLOGIST WAS INFORMED ABOUT THE INFECTIVE ENDOCARDITIS (IE) SUSPICION. ON DAY 8 ALL THREE SETS OF BLOOD CULTURES OBTAINED BEFORE ANTIBIOTIC THERAPY WAS INITIATED WERE GROWING CORYNEFORM GRAM-POSITIVE BACILLI IN ANAEROBIC BOTTLES. SO PROPIONIBACTERIUM SPP. WERE CONSIDERED THE RESPONSIBLE FOR THE IE AND AN ANTIBIOGRAM-GUIDED DE-ESCALATION WAS MADE TO PENICILLIN G (24 MILLION IU/24 H). THE PATIENT UNDERWENT SURGERY ON DAY 11. UNFORTUNATELY THE POSTOPERATIVE COURSE WAS COMPLICATED BY REFRACTORY SHOCK AND MULTI-ORGANIC FAILURE, AND THE PATIENT DIED 48 HRS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743802 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE HEART VALVE DYE LIVANOVA CANADA CORP. CNA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| R