BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1020342 · Received March 27, 2008

    Report

    Report Number
    6000002-2008-06367
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 26, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: A SUTURE MOST LIKELY LOOPED AROUND COMMISSURE 1, AS SUTURE TRACK MARKS ARE EVIDENT IN THE FREE MARGINS OF LEAFLETS 1 AND 3. SUTURE TRACK MARKS ARE ALSO DETECTED AT THE FREE MARGIN OF LEAFLETS 1 AND 2, WHICH SUGGESTS A SECOND SUTURE MOST LIKELY LOOPED OVER COMMISSURE 2. THE DISRUPTIONS DUE TO THE SUTURE LOOP LED TO INCOMPLETED COAPTATION. THE X-RAY DEMONSTRATES SLIGHT STENT DISTORTION POSSIBLY DUE TO IMPLANT OR EXPLANT. DEVICE RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY THIS DEVICE WAS A POSSIBLE SUTURE LOOP DUE TO UNFAMILIAR NEW STAFF WHICH HAD NOT DEPLOYED TRICENTRIX HOLDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 6900 R-07J1898

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention