BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM TRIFECTA VALVE

    MDR report key: 9504956 · Received December 20, 2019

    Report

    Report Number
    3008452825-2019-00632
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    November 26, 2019
    Report Date
    February 3, 2020
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    LWR
    UDI-DI
    05414734052047
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALCIFICATION SEEN AT EXPLANT WAS CONFIRMED. ALL THREE LEAFLETS CONTAINED CALCIFICATIONS. LEAFLETS 2 AND 3 CONTAINED TEARS WHICH WERE ASSOCIATED WITH CALCIFICATIONS. THERE WAS CIRCUMFERENTIAL FIBROUS PANNUS INGROWTH ON THE INFLOW SURFACE AND ON THE OUTFLOW SURFACE OF LEAFLET 1. NO INFLAMMATION WAS PRESENT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF COMMERCIALIZATION. THE CAUSE OF THE TEAR COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE TEARS WERE ASSOCIATED WITH CALCIFICATIONS.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A 25MM TRIFECTA VALVE WAS IMPLANTED. THE VALVE WAS REPORTED TO BE VERY CALCIFIED WITH RIGID SIGMOIDS. ON (B)(6) 2019, THE VALVE WAS EXPLANTED AND DURING EXPLANTED A TRAUMATIC SIGMOID TEAR WAS REPORTED. THE VALVE WAS EXCHANGED FOR 23MM CARPENTIER EDWARDS MAGNA EASE VALVE. POST IMPLANT THE PATIENT WAS REPORTED TO BE STABLE. SHORTLY AFTER EXPLANT PROCEDURE THE PATIENT PRESENTED WITH PSOAS HEMATOMA, LUMBAR EMBOLIZATION AND THE PATIENT HAS A DOUBLE J CATHETER STENT PLACED AND THEIR VENTILATION HAS BEEN EXTENDED. THE POST OPERATIVE COMPLICATION ARE UNRELATED TO THE EXPLANT PROCEDURE. THE PATIENT WAS REPORTED TO BE IN UNSTABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296375 SJM TRIFECTA VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, COSTA RICA LTDA TF-25A 4346942 05414734052047

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R