BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX SUTURE CV5

    MDR report key: 1373455 · Received April 30, 2009

    Report

    Report Number
    3003910212-2009-00011
    Event Type
    Injury
    Date Received
    April 30, 2009
    Date of Event
    February 24, 2009
    Report Date
    April 30, 2009
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DTH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS. HISTOLOGY AND ENGINEERING EVALUATIONS OF RETURNED DEVICE. HISTOLOGY EVALUATION OF THE RETURNED DEVICE WAS UNREMARKABLE. ONE SUTURE TAIL DEMONSTRATED MILD NARROWING. THE TISSUE RESPONSE APPEARS UNREMARKABLE WITH THE INTERSTICES PREDOMINATELY FILLED WITH PROTEINACEOUS MATERIAL AND SCARCE HISTOCYTES. THERE IS NO EVIDENCE OF MINERALIZATION OR INFECTION WITH BACTERIA.

    Description of Event or Problem · 1

    GORE RECEIVED THE FOLLOWING INFORMATION: IN 2006, THE PATIENT UNDERWENT MITRAL VALVE RECONSTRUCTION WITH REPLACEMENT OF THE CHORDAE TENDINEAE WITH GORE-GEX SUTURE (CV-5). IN 2009, THE PATIENT VISITED THE HOSPITAL DUE TO THE SICK FEELING. THE MEDICAL CHECK (INCLUDING THE ULTRASONOGRAPHIC FINDINGS) REVEALED THAT ONE OF THE ANTERIOR LEAFLET SUTURES HAD RUPTURED. THE FOLLOWING MONTH, RE-OPERATION WAS PERFORMED AND THE RUPTURED SUTURE WAS REPLACED WITH THE NEW GORE-TEX SUTURE. THE PATIENT TOLERATED THE PROCEDURE. THERE WAS NO ALLEGATION OF PRODUCT DEFICIENCY MADE BY THE PHYSICIAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX SUTURE CV5 NONE DTH W.L. GORE & ASSOCIATES WLG605

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR