BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 1896127 · Received November 10, 2010

    Report

    Report Number
    2015691-2010-14344
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 12, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)=SUTURE LOOPING.DEVICE NOT RETURNED DUE TO DEVICE WAS DISCARDED.THE DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE DUE TO NO LOT/SERIAL NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON SUTURED LOOPED TWO 7000TFX, 29MM VALVES ON THE SAME PATIENT. THE SURGEON FELT HE HAD THE TRICENTRIX DEPLOYED PROPERLY AND KEPT IT ATTACHED THE WHOLE TIME. HE FEELS HE CAUGHT THE SUTURE ON THE RIDGE OF THE STENT POST. THE DEVICE IS UNAVAILABLE FOR RETURN AS IT WAS DISCARDED. (B)(4) THE FIRST 7000TFX, 29MM EXPLANTED, MANUFACTURER REPORT # 2015691-2010-14343.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention