BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX SUTURE

    MDR report key: 3093905 · Received April 26, 2013

    Report

    Report Number
    3003910212-2013-00009
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    January 12, 2011
    Report Date
    March 21, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    GAW
    PMA / PMN Number
    P820083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE AUTHOR. THE CASE REPORT DOES NOT SPECIFY THE NUMBER OF SUTURES INVOLVED IN CREATING THE NEOCHORDAE IN THE INITIAL PROCEDURE. THE AUTHORS HYPOTHESIZE THAT THE SUTURE FAILURE IS LIKELY DUE TO INTRACARDIAC FORCES THAT EXCEED THE STRENGTH OF THE SUTURE RATHER THAN A STRUCTURAL CHANGE OF THE SUTURE LEADING TO A FAILURE. BASED ON THE LIMITED INFORMATION PROVIDED, A ROOT CAUSE HAS NOT BEEN DETERMINED. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING, TRENDING AND FOLLOW-UP. CITATION: MICHAEL H. YAMASHITA, PETER L. SKARSGARD, INTERMEDIATE AND EARLY RUPTURE OF EXPANDED POLYTETRAFLUOROETHYLENE NEOCHORDAE AFTER MITRAL VALVE REPAIR. THE ANNALS OF THORACIC SURGERY 2011:92:341-343.

    Description of Event or Problem · 1

    A REVIEW OF THE ANNALS OF THORACIC SURGERY, (B)(6) 2011, REVEALED A CASE REPORT ENTITLED, "INTERMEDIATE AND EARLY RUPTURE OF EXPANDED POLYTETRAFLUOROETHYLENE NEOCHORDAE AFTER MITRAL VALVE REPAIR". THIS REPORT DESCRIBES A (B)(6) MALE PATIENT WITH SEVERE MITRAL REGURGITATION WITH PROLAPSE NECESSITATING MITRAL VALVE REPLACEMENT 6 MONTHS AFTER THE INITIAL REPAIR. THE AUTHORS NOTED THAT ALL OF THE CV-5 EPTFE NEOCHORDAE (GORE-TEX SUTURE) AND NATIVE CHORDAE WERE FOUND TO BE RUPTURED. THE VALVE REPLACEMENT WAS SUCCESSFUL AND AT 11 MONTHS POST-OP, THE PATIENT WAS FOUND TO HAVE A NORMAL FUNCTIONING PROSTHETIC MV AND GOOD LEFT VENTRICULAR FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181412 GORE-TEX SUTURE GAW/SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention