BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED PORCINE HEART VALVE

    MDR report key: 3780678 · Received April 18, 2014

    Report

    Report Number
    3001743903-2014-00023
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INFO PROVIDED TO SJM INDICATED A 23MM EPIC VALVE WAS IMPLANTED ON DUE TO SEVERE AORTIC STENOSIS AND A RADICAL PROSTATECTOMY WAS ALSO PERFORMED. IN THE YEAR FOLLOWING SURGERY, THE PT WAS OPERATED ON FOR PROSTATE CANCER AND RECEIVED HORMONE THERAPY AND RADIATION TREATMENT. DURING THE FALL OF 2013, THE PT EXPERIENCED SYNCOPE AND FATIGUE. AN ECHOCARDIOGRAM REVEALED MODERATE LEAKAGE, THICKENED AND CALCIFIED LEAFLETS, SEVERE STENOSIS AND A GRADIENT OF 58 MMHG. PANNUS WAS OBSERVED AFTER EXPLANT. A 23MM TRIFECTA (MODEL: TF-23A, S/N: (B)(4)) WAS IMPLANTED AND THE PT WAS RECOVERING FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238812 SJM EPIC STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST JUDE MEDICAL BRASIL LTDA E100-23A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R