BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM TRIFECTA VALVE

    MDR report key: 8065017 · Received November 13, 2018

    Report

    Report Number
    3001883144-2018-00093
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    October 23, 2018
    Report Date
    January 4, 2019
    Manufacturer
    ST. JUDE MEDICAL, BRASIL LTDA.
    Product Code
    LWR
    UDI-DI
    05414734052030
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVENTS OF AORTIC REGURGITATION AND LEAFLET TEARS WERE REPORTED. GROSS MORPHOLOGICAL AND HISTOPATHOLOGICAL EXAMINATION REVEALED LEAFLETS 1 AND 2 WERE TORN AT STENT POST 2. CIRCUMFERENTIAL FIBROUS PANNUS INGROWTH WAS OBSERVED ON THE INFLOW SURFACE ENCROACHING ONTO THE BASES OF ALL THREE LEAFLETS, NARROWING THE INFLOW DIAMETER. FIBROUS PANNUS INGROWTH WAS ALSO OBSERVED ON THE OUTFLOW SURFACES OF LEAFLETS 2 AND 3. NO ACUTE INFLAMMATION OR SIGNIFICANT CALCIFICATIONS WERE OBSERVED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. AORTIC REGURGITATION IS CONSISTENT WITH TORN LEAFLETS. ADDITIONALLY, CIRCUMFERENTIAL FIBROUS PANNUS INGROWTH ON THE INFLOW SURFACE CAN ALTER THE DISTRIBUTION OF STRESS, HOWEVER THE EXACT CAUSE OF THE LEAFLET TEARING REMAINS UNKNOWN.

    Description of Event or Problem · 0

    ON (B)(6) 2013, AN AORTIC VALVE REPLACEMENT (AVR) WAS PERFORMED DUE TO CONGENITAL BICUSPID VALVE AND THIS 23MM TRIFECTA VALVE WAS IMPLANTED. IN (B)(6) 2018, THE PATIENT PRESENTED WITH EDEMA AND SEVERE AORTIC REGURGITATION (AR) WAS DIAGNOSED BY AN ECHOCARDIOGRAM. THE LEAKAGE WAS NOTED AT THE COMMISSURE OF THIS VALVE. ON (B)(6) 2018, RE-DO AVR WAS PERFORMED AND THIS VALVE WAS EXPLANTED AND REPLACED WITH A 23MM EDWARDS INSPIRIS RESILIA AORTIC VALVE. AFTER EXPLANT, TEARS WERE EXHIBITED AT THE NON-CORONARY CUSP (NCC) ALONG THE STENT POST BETWEEN THE NCC AND A RIGHT CORONARY CUSP (RCC). PANNUS-LIKE WHITE TISSUE WAS ALSO CONFIRMED CIRCUMFERENTIALLY ON THE BASE OF CUSPS ON THE INFLOW SIDE AND WHICH COVERED OVER THE RCC. THE PATIENT WAS REPORTED TO BE STABLE POSTOPERATIVELY AND DISCHARGED. THE SURGEON ATTRIBUTED THIS INCIDENT TO THE VALVE ITSELF AS THE CUSPS HAD NOT HAD ANY IMPEDED MOBILITY ASSOCIATED WITH THE PANNUS-LIKE TISSUE. ECHO AND OP REPORTS WERE REQUESTED, BUT NOT MADE AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, AN AORTIC VALVE REPLACEMENT (AVR) WAS PERFORMED DUE TO CONGENITAL BICUSPID VALVE AND THIS 23MM TRIFECTA VALVE WAS IMPLANTED. IN (B)(6) 2018, THE PATIENT PRESENTED WITH EDEMA AND SEVERE AORTIC REGURGITATION (AR) WAS DIAGNOSED BY AN ECHOCARDIOGRAM. THE LEAKAGE WAS NOTED AT THE COMMISSURE OF THIS VALVE. ON (B)(6) 2018, RE-DO AVR WAS PERFORMED AND THIS VALVE WAS EXPLANTED AND REPLACED WITH A 23MM EDWARDS INSPIRIS RESILIA AORTIC VALVE. AFTER EXPLANT, TEARS WERE EXHIBITED AT THE NON-CORONARY CUSP (NCC) ALONG THE STENT POST BETWEEN THE NCC AND A RIGHT CORONARY CUSP (RCC). PANNUS-LIKE WHITE TISSUE WAS ALSO CONFIRMED CIRCUMFERENTIALLY ON THE BASE OF CUSPS ON THE INFLOW SIDE AND WHICH COVERED OVER THE RCC. THE PATIENT WAS REPORTED TO BE STABLE POSTOPERATIVELY. THE SURGEON ATTRIBUTED THIS INCIDENT TO THE VALVE ITSELF AS THE CUSPS HAD NOT HAD ANY IMPEDED MOBILITY ASSOCIATED WITH THE PANNUS-LIKE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904537 SJM TRIFECTA VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, BRASIL LTDA. TF-23A 3998460 05414734052030

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R