BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA¿ VALVE

    MDR report key: 4130398 · Received September 30, 2014

    Report

    Report Number
    3008452825-2014-00038
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    LWR
    PMA / PMN Number
    PP100029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED IN (B)(6) 2014, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH AND ECHOCARDIOGRAPHY REVEALED AORTIC INSUFFICIENCY. THE VALVE WAS EXPLANTED AND DURING THE PROCEDURE, A CUSPAL TEAR WAS OBSERVED. THE VALVE WAS REPLACED WITH A BIOPROSTHESIS FROM ANOTHER MANUFACTURER. IT WAS REPORTED THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609415 TRIFECTA¿ VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, COSTA RICA LTDA TF-25A 3566625

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R