BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE-TEX SUTURE FOR CHORDAE TENDINEAE

    MDR report key: 12064859 · Received June 25, 2021

    Report

    Report Number
    3003910212-2021-01253
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    December 8, 2020
    Report Date
    July 20, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    GAW
    PMA / PMN Number
    P820083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: ¿QUADRANGULAR RESECTION VERSUS CHORDAL REPLACEMENT FOR DEGENERATIVE POSTERIOR MITRAL LEAFLET PROLAPSE¿ PUBLISHED BY ANNALS OF TRANSLATIONAL MEDICINE. ANN TRANSL MED 2021;9(1):60. THE AUTHORS: JIEXU MA, JIAN LIU, PEIJIAN WEI, XIMENG YAO, YUYUAN ZHANG, LIANGZHENG FANG, ZHAO CHEN, YANJUN LIU, TONG TAN, HONGXIANG WU, HUANLEI HUANG, BIN XIE, JIMEI CHEN, JIAN ZHUANG, HUIMING GUO SUBMITTED OCT 21, 2020. ACCEPTED FOR PUBLICATION DEC 08, 2020. DOI: 10.21037/ATM-20-7475 VIEW THIS ARTICLE AT: HTTP://DX.DOI.ORG/10.21037/ATM-20-7475.

    Additional Manufacturer Narrative · 1

    DUE TO AN UNKNOWN LOT/SERIAL NUMBER AND NO DEVICE RETURN, AN INVESTIGATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED THROUGH LITERATURE ¿QUADRANGULAR RESECTION VERSUS CHORDAL REPLACEMENT FOR DEGENERATIVE POSTERIOR MITRAL LEAFLET PROLAPSE¿ PUBLISHED BY ANNALS OF TRANSLATIONAL MEDICINE. ANN TRANSL MED 2021;9(1):60. THE STUDY WAS TO COMPARE MIDTERM RESULTS OF QUADRANGULAR LEAFLET RESECTION VERSUS CHORDAL REPLACEMENT FOR THE REPAIR OF DEGENERATIVE POSTERIOR MITRAL LEAFLET (PML) PROLAPSE, AND TO EXPLORE THE RISK FACTORS FOR RECURRENT SEVERE MITRAL REGURGITATION (MR). FOR CHORDAL REPLACEMENT, A 4-0 OR 5-0 EXPANDED POLYTETRAFLUOROETHYLENE (EPTFE) GORE-TEX SUTURE (W. L. GORE & ASSOCIATES, INC, (B)(4), USA) WITH A GASKET WAS MAINLY USED. THE RESULTS STATE THAT IN RECURRENT MR AND MV REOPERATION, 1 FOR ARTIFICIAL CHORDAE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968052 GORE-TEX SUTURE FOR CHORDAE TENDINEAE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR