BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM

    MDR report key: 10872670 · Received November 19, 2020

    Report

    Report Number
    3008452825-2020-00655
    Event Type
    Injury
    Date Received
    November 19, 2020
    Date of Event
    October 14, 2020
    Report Date
    December 17, 2020
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA (CVD)
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXPLANT WAS REPORTED DUE TO MITRAL REGURGITATION AND LIMITED MOBILITY. THE INVESTIGATION FOUND THAT THERE WAS MARKED CIRCUMFERENTIAL FIBROUS PANNUS INGROWTH ON THE INFLOW SURFACE OF THE CUSPS WHICH NARROWED THE INFLOW DIAMETER MARKEDLY AND LIMITED THE CUSP MOBILITY. THERE WAS FIBROUS PANNUS INGROWTH ON THE OUTFLOW SURFACE OF CUSPS 1 AND 2 WHICH EXTENDED OVER THE COMMISSURES OF THE CUSPS. THERE WAS A TEAR IN CUSP 3. THERE WAS ORGANIZING THROMBUS UNDERLYING THE PANNUS IN CUSPS 2 AND 3, AND IN CUSP 2 CALCIFICATIONS WERE ALSO UNDERLYING THE PANNUS. CUSP 3 CONTAINED A FOLD. NO ACUTE 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. THE PANNUS NOTED WOULD HAVE CONTRIBUTED TO THE REPORTED LIMITED LEAFLET MOBILITY AND THE REGURGITATION. THE CAUSE OF THE TEAR COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE FIBROUS PANNUS INGROWTH NOTED HAD THE POTENTIAL TO INDUCE INCREASED STRESS ON ADJACENT LEAFLETS AND CREATE AN UNBALANCED STRESS RELIEF DISTRIBUTION BETWEEN ALL LEAFLETS DURING COAPTATION, LEADING TO LEAFLET TEARS AND REDUCED DURABILITY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED. IF RETURNED, INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A 31MM EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM WAS IMPLANTED IN THE PATIENT'S MITRAL POSITION. AN ABBOTT SIZER WAS USED IN THE SURGERY. PROSTHETIC VALVE ENDOCARDITIS OCCURRED ON THE PATIENT TWO YEARS AGO WHICH IMPROVED WITH MEDICATION. HOWEVER, OPENING/CLOSING MOBILITY OF THE P3 SIDE OF THE POSTERIOR CUSP WAS LIMITED WHICH GRADUALLY LED TO MITRAL REGURGITATION(MR). ON (B)(6) 2020, A RE-DO MVR WAS PERFORMED AND THE EPIC VALVE WAS EXPLANTED, REPLACED WITH A MOSAIC BIOPROSTHESIS MITRAL VALVE(MANUFACTURER: MEDTRONIC). THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337689 EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, COSTA RICA LTDA (CVD) E100-31M 5535367

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention