BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MASTERS SERIES MECHANICAL HEART VALVE

    MDR report key: 3883748 · Received June 6, 2014

    Report

    Report Number
    2648612-2014-00025
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 6, 2011
    Report Date
    May 19, 2014
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, 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 THROMBUS WAS SUSPECTED TO BE CAUSED BY HYPEREOSINOPHILIA. THE PHYSICIAN DID NOT ALLEGE THE EVENT WAS CAUSED BY THE DEVICE.

    Description of Event or Problem · 1

    THE INFORMATION IN A LITERATURE ARTICLE INDICATED THE PT UNDERWENT AORTIC VALVE REPLACEMENT WITH THIS 23 MM SJM MASTERS SERIES VALVE DUE TO PERSISTENT LEFT ATRIOVENTRICULAR REGURGITATION. INR WAS MAINTAINED AND APPROXIMATELY ONE MONTH POSTOPERATIVELY, THE PT PRESENTED WITH DYSPNEA AND THE VALVE WAS DETERMINED TO BE THROMBOSED. THROMBOLYTIC THERAPY WITH UROKINASE WAS PERFORMED. ONE MONTH AFTER THE EMERGENCY THROMBECTOMY, THE PT PRESENTED WITH AN ELEVATED HEART RATE AND TACHYPNEA. THE VALVE WAS FOUND TO BE THROMBOSED AGAIN. THE VALVE WAS EXPLANTED AND A SMALLER 21 MM SJM MASTERS SERIES VALVE (MEDWATCH REPORT #2648612-2014-00026) WAS IMPLANTED. TEN DAYS FOLLOWING THE RE-DO VALVE REPLACEMENT, THE PT PRESENTED AGAIN WITH DYSPNEA AND INTENSIFIED PERIPHERAL COLDNESS. THROMBOLYTIC THERAPY WAS UNSUCCESSFUL AND CIRCULATION WAS UNSTABLE. THE 21 MM VALVE WAS EXPLANTED AND REPLACED WITH A 22 MM VALVE FROM ANOTHER MANUFACTURER. ACCORDING TO THE LITERATURE ARTICLE, THE HYPEREOSINOPHILIA WAS STRONGLY SUSPECTED TO BE THE CAUSE OF THE REPEATED VALVE THROMBOSIS. ANTIBIOTICS WERE SUSPECTED TO BE THE CAUSE OF THE HYPEREOSINOPHILIA. THEREFORE, THE ADMINISTRATION OF ANTIBIOTICS WAS STOPPED, THE EOSINOPHIL COUNT WAS GRADUALLY NORMALIZED, AND THE PT WAS DISCHARGED IN GOOD CONDITION. IT WAS REPORTED THE PHYSICIAN ALLEGED THIS EVENT WAS NOT CAUSED BY THE VALVES. KIDO T., ET AL, "REPEATED OBSTRUCTIVE PROSTHETIC VALVE THROMBOSIS SUSPECTED TO BE ASSOCIATED WITH HYPEREOSINOPHILIC SYNDROME IN COMPLETE ATRIOVENTRICULAR SEPTAL DEFECT, " PEDIATRIC CARDIOLOGY AND CARDIAC SURGERY, VOL.30 NO. 2 (200-204).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333176 SJM MASTERS SERIES MECHANICAL HEART VALVE ROTATABLE HEART VALVE LWQ ST. JUDE MEDICAL PUERTO RICO, INC. 23AJ-501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| R