BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX SUTURE

    MDR report key: 450101 · Received March 25, 2003

    Report

    Report Number
    2017233-2003-00001
    Event Type
    Injury
    Date Received
    March 25, 2003
    Date of Event
    November 12, 2002
    Report Date
    March 25, 2003
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    DTH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED CV-5 GORE-TEX SUTURE IN A CHORDAE TENDINEAE REPLACEMENT PROCEDURE TO REPAIR A RUPTURED ANTERIOR LEAFLET. APPROXIMATELY THREE YEARS POSTOPERATIVELY PT PRESENTED WITH LOW-GRADE PULMONARY EDEMA. SURGERY REPORTEDLY REVEALED A MID-POINT RUPTURE OF THE SUTURE. CV-3 GORE-TEX SUTURE WAS PLACED, ACHIEVING COMPLETE COMPETENCE OF THE VALVE. THE PT'S RECOVERY WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX SUTURE NONABSORBABLE SUTURE DTH W.L. GORE & ASSOCIATES,INC WLG605 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention