BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM TRIFECTA VALVE

    MDR report key: 6197444 · Received December 21, 2016

    Report

    Report Number
    3008452825-2016-00182
    Event Type
    Injury
    Date Received
    December 21, 2016
    Report Date
    November 29, 2016
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    LWR
    PMA / PMN Number
    P100029
    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. 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 JOURNAL OF THE JAPANESE SOCIETY OF CARDIOVASCULAR ANESTHESIOLOGISTS" 2016, VOL.20, SUPPL, PAGE 271 (EP-2-2-6); ARTICLE, "A CASE OF MID-VENTRICULAR OBSTRUCTION (MVO) AFTER AORTIC VALVE REPLACEMENT (AVR)". WE OBTAINED THIS INFORMATION THROUGH A WEEKLY DOCUMENT RETRIEVAL SERVICE FROM AN OUTSOURCING COMPANY (AVAILABLE ONLY IN JAPANESE). ON AN UNKNOWN DATE, AN AORTIC VALVE REPLACEMENT (AVR) WAS PERFORMED AND A 19 MM TRIFECTA VALVE WAS IMPLANTED IN A PATIENT WITH A MEDICAL HISTORY OF HYPERTENSION AND AORTIC STENOSIS (AS). PREOPERATIVELY, THE PATIENT'S PEAK VELOCITY WAS NOTED TO BE 4.8M/SEC. INTRAOPERATIVELY, THE PATIENT WAS TAKEN OFF CARDIOPULMONARY BYPASS UNDER CONTINUOUS ADMINISTRATION OF DOPAMINE (3MCG/KG/MIN) AFTER IMPLANTATION OF THE TRIFECTA VALVE. DURING HEMOSTASIS, CENTRAL VENOUS PRESSURE (CVP) DECLINED FROM 8 MMHG TO 6 MMHG AND HYPOTENSION WAS CONFIRMED. A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED AND ALL THREE CUSPS WERE NOTED TO BE MOBILE WITH NO ANOMALIES. REPORTEDLY, PEAK VELOCITY WAS 2.3M/SEC IN AORTIC VALVE AND 1.5M/SEC IN LEFT VENTRICULAR OUTFLOW TRACT (LVOT). THE MOBILITY OF THE MITRAL VALVE LEAFLETS WERE NORMAL. HOWEVER, PEAK VELOCITY IN MID-LEFT VENTRICLE WAS CONFIRMED TO INCREASE TO 4.8M/SEC. THUS, THE CAUSE OF THE HYPOTENSION WAS IDENTIFIED AS MID-VENTRICULAR OBSTRUCTION (MVO). DOPAMINE WAS IMMEDIATELY DISCONTINUED TO ADMINISTER AND ADEQUATE INTRAVENOUS FLUIDS WAS ADMINISTERED. SUBSEQUENTLY, THE MVO PEAK VELOCITY WENT DOWN TO 2.8M/SEC AND BLOOD PRESSURE BECAME STABLE. ON THE 9TH POSTOPERATIVE DAY, TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) WAS PERFORMED. IT REVEALED THAT THE SYMPTOMS OF MVO HAD BEEN RESOLVED. THIS VALVE REMAINS IMPLANTED IN THE AORTIC POSITION. ALTHOUGH THERE IS A CASE WHERE SYMPTOMS OF MVO APPEARS AFTER AVR, HEMODYNAMICS IMPROVED DUE TO APPROPRIATE MANAGEMENT OF CIRCULATION IN THIS CASE. REGARDING THIS CASE, THE REPORTED MVO WAS TRANSIENT SYMPTOM AND ANY SURGICAL INTERVENTION WAS CONSEQUENTLY AVOIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845042 SJM TRIFECTA VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, COSTA RICA LTDA TF-19A

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R