BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM

    MDR report key: 4202681 · Received October 27, 2014

    Report

    Report Number
    3001883144-2014-00024
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 1, 2014
    Report Date
    October 6, 2014
    Manufacturer
    ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA)
    Product Code
    LWR
    PMA / PMN Number
    PP040021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 27MM EPIC VALVE WAS RETURNED TO SJM FOR ANALYSIS. THE RESULTS OF THE INVESTIGATION CONCLUDED THERE WERE TEARS ON CUSPS 1 AND 2, A THIN LAYER OF FIBRIN ON THE INFLOW AND OUTFLOW SURFACES OF CUSPS 1 AND 3, AND FIBRIN DEPOSITION WITHIN THE CUSPAL TISSUE ON ALL THE 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 TEARS 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 TEARS REMAINS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE EPIC VALVE WAS EXPLANTED DUE TO MITRAL REGURGITATION (MR) AND REPLACED WITH A 25MM, NON-SJM MECHANICAL HEART VALVE. DURING EXPLANT, AORTIC REGURGITATION (AR) OCCURRED TWICE. AFTER THE EPIC TISSUE VALVE WAS EXPLANTED, ONE OF THE CUSPS WAS TORN ALONG THE STENT BASE WHILE THE POSTEROMEDIAL SIDE REMAINED ATTACHED TO THE STENT. THE PHYSICIAN ALLEGED THAT THE EVENT WAS CAUSED BY THE EPIC TISSUE VALVE AS THE PATIENT DID NOT DEMONSTRATE INFECTIVE ENDOCARDITIS OR OTHER FINDINGS. THE PATIENT WAS STABILIZED POSTOPERATIVELY. THE EVENT DATE WAS AN ESTIMATION.

    Description of Event or Problem · 1

    DURING EXPLANT, AORTIC REGURGITATION (AR, GRADE 4) OCCURRED TWICE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, AN EPIC VALVE WAS EXPLANTED DUE TO MR AND REPLACED WITH A 25MM, NON-SJM MECHANICAL HEART VALVE. DURING EXPLANT, AORTIC REGURGITATION (AR) WAS NOTED ON TWO OCCASIONS. AFTER EXPLANTATION OF THE EPIC VALVE IT WAS NOTED ONE OF THE CUSPS TORE ALONG THE STENT BASE FROM THE A1-P1 COMMISSURE (ANTEROLATERAL COMMISSURE) WHILE THE POSTEROMEDIAL COMMISSURE SIDE REMAINED ATTACHED TO THE STENT. THE PHYSICIAN ALLEGED THAT THE EVENT WAS CAUSED BY THE EPIC TISSUE VALVE AS THE PATIENT DID NOT DEMONSTRATE INFECTIVE ENDOCARDITIS OR OTHER FINDINGS. THE PATIENT WAS STABILIZED POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683525 EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) E100-27M 3744582

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention