BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPRSTHESIS

    MDR report key: 1231828 · Received November 11, 2008

    Report

    Report Number
    6000002-2008-09248
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 22, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUTURE LOOPING OF THE COMMISSURE STENT POST. DEVICE NOT RETURNED. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON EXPERIENCED A POST SUTURE LOOP AROUND THE POSTERIOR COMMISSURE STENT POST DURING IMPLANTING OF THE DEVICE. REPORTEDLY, THE TRICENTRIX HOLDER WAS PROPERLY DEPLOYED. REPORTEDLY, THE SURGEON OBSERVED INCREASED RESISTANCE ON THE SEWING RING WHEN HE WAS SUTURING THROUGH THE SEWING RING AND WHEN PARACHUTING THE VALVE DOWN TO THE MITRAL ANNULUS. THE POST SUTURE LOOP WAS OBSERVED DURING THE ECHO. REPORTEDLY, THE SURGEON WAS ABLE TO CORRECT THE SUTURE LOOP OVER THE POSTERIOR COMMISSURE STENT POST INTRAOPERATIVELY. THE SURGEON ADDED PLEDGET ON THE REPLACED SUTURES TO REINFORCE THE MITRAL ANNULUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPRSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 7000TFX R-08J1962

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention