BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCOR SUPRA VALVE

    MDR report key: 4200555 · Received October 24, 2014

    Report

    Report Number
    3001743903-2014-00051
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 29, 2014
    Manufacturer
    ST. JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    PMA / PMN Number
    PP040021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THIS INVESTIGATION CONCLUDED THE CUSPS WERE RECEIVED FRAGMENTED WITH ALL CUSPS PARTIALLY EXCISED; THERE WAS MILD FIBROUS THICKENING OF THE UNDESIGNATED DETACHED CUSPS, PERFORATIONS MEASURING 1-2 MM ON THE TWO UNDESIGNATED CUSPS, AND A THIN LAYER OF FIBRIN ON ALL CUSPS. SPECIAL STAINS WERE NEGATIVE FOR ORGANISMS, AND NO ACUTE INFLAMMATION OR SIGNIFICANT CALCIFICATIONS WERE PRESENT. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE CAUSE OF THE FIBRIN FORMATION AND PERFORATIONS WERE DUE TO AN INTRINSIC DEFECT IN THE VALVE, AS SUPPORTED BY REVIEW OF THE VALVE'S DEVICE HISTORY RECORD AND THE ANALYSIS PERFORMED. THE CAUSE OF THE FIBRIN FORMATION AND PERFORATIONS REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE VALVE WAS EXPLANTED DUE TO STENOSIS. DURING THE EXPLANT PROCEDURE, TWO PERFORATIONS IN THE CUSPS WERE OBSERVED WHICH WERE THOUGHT TO BE THE CAUSE OF THE AORTIC INSUFFICIENCY. IT WAS REPORTED THE STENOSIS LIKELY TO BE DUE TO SUBVALVULAR INFLAMMATORY TISSUE GROWTH. THE PATIENT EXPIRED POSTOPERATIVELY (DATE AND CAUSE UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679137 BIOCOR SUPRA VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL BRASIL LTDA. B10SP-21 0002105543

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| H| R