BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM TRIFECTA VALVE

    MDR report key: 6337605 · Received February 16, 2017

    Report

    Report Number
    3008452825-2017-00023
    Event Type
    Death
    Date Received
    February 16, 2017
    Report Date
    January 31, 2017
    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. 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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A 23MM JLL SOLO STENTLESS AORTIC VALVE MANUFACTURED BY (B)(4) LIFELINE CO. LTD WAS IMPLANTED ALONG WITH AN AORTIC ROOT REPAIR. ON (B)(6) 2016, A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED IMPEDED MOBILITY OF THE JLL SOLO STENTLESS AORTIC VALVE AND REDO AVR WAS REQUIRED. THE JLL SOLO WAS EXPLANTED AND THIS 25MM TRIFECTA VALVE WAS IMPLANTED. AFTER THE REOPERATION, THE PATIENT DID NOT RECOVER AND THE PATIENT REPORTEDLY EXPIRED ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION COULD BE OBTAINED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117376 SJM TRIFECTA VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, COSTA RICA LTDA TF-25A 5412767

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H