BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM TRIFECTA VALVE

    MDR report key: 5532701 · Received March 29, 2016

    Report

    Report Number
    3008452825-2016-00040
    Event Type
    Injury
    Date Received
    March 29, 2016
    Report Date
    March 8, 2016
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA (CVD)
    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

    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

    ACCORDING TO THE ARTICLE "ANTERIOR LONGITUDINAL AORTOTOMY IN AORTIC VALVE REPLACEMENT" (GENERAL THORACIC AND CARDIOVASCULAR SURGERY, DOI 10.1007/S11748-015-0600-5), A PATIENT UNDERWENT A CONCOMITANT AORTIC VALVE REPLACEMENT (21MM TRIFECTA VALVE) AND CORONARY ARTERY BYPASS GRAFTING ON AN UNKNOWN DATE. PATIENT MEDICAL HISTORY INCLUDED AORTIC STENOSIS (AS), LEFT VENTRICULAR OUTFLOW TRACT STENOSIS (LVOTS), PRIOR MYOCARDIAL INFARCTION, PULMONARY HYPERTENSION, CHRONIC RENAL FAILURE REQUIRING DIALYSIS AND ISCHEMIC HEART DISEASE. POST PROCEDURE A CASE OF LOW OUTPUT SYNDROME (LOS)) RESULTED IN A PATIENT'S DEATH (NO. 14).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188347 SJM TRIFECTA VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, COSTA RICA LTDA (CVD) TF-21A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention