BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX® SUTURE

    MDR report key: 25010724 · Received April 27, 2026

    Report

    Report Number
    3003910212-2026-01654
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    June 16, 2023
    Report Date
    April 28, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    GAW
    PMA / PMN Number
    P820083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. D4: THE LOT NUMBER AND CATALOG NUMBER REMAIN UNKNOWN. ARTICLE CITATION: CHANG. A NOVEL TECHNIQUE FOR THE PERMANENT RESTORATION OF PRETARSAL FULLNESS OF THE LOWER EYELIDS. AESTHETIC SURG J OPEN FORUM. 2023;5:OJAD047. DOI:10.1093/ASJOF/OJAD047 AVAILABLE ONLINE 16-JUN-2023, EVENT DATE IS UNKNOWN THEREFORE REFLECT THE LITERATURE ARTICLE AVAILABLE ONLINE DATE. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS RECEIVED THROUGH LITERATURE: A NOVEL TECHNIQUE FOR THE PERMANENT RESTORATION OF PRETARSAL FULLNESS OF THE LOWER EYELIDS. AESTHETIC SURG J OPEN FORUM. 2023;5:OJAD047. THE OBJECTIVE OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE SAFETY AND LONG-TERM OUTCOMES OF A NOVEL TECHNIQUE FOR PRETARSAL FULLNESS AUGMENTATION USING IMPLANTS CREATED WITH SEGMENTED AND BUNDLED GORE-TEX SUTURES OVERLAID WITH MASTOID FASCIA GRAFTS. THIS STUDY INCLUDED 16 FEMALES [MEAN AGE 30 YEARS] WHO UNDERWENT RESTORATION OF STATIC PRETARSAL FULLNESS BETWEEN 2007 AND 2022. THE SURGERY CONSISTED OF MULTIPLE SEGMENTS OF 3-0 GORE-TEX SUTURES BUNDLED AND SECURED TO THE LOWER EYELID TARSAL PLATE, THEN COVERAGE WITH A FASCIA GRAFT. A 22-YEAR-OLD FEMALE PATIENT DEVELOPED A POSTOPERATIVE INFECTION INVOLVING THE GORE-TEX SUTURE IMPLANT, INITIALLY MANAGED WITH ANTIBIOTICS; HOWEVER, PERSISTENT INFECTION REQUIRED REMOVAL OF THE GORE-TEX SUTURE BUNDLE, FOLLOWED BY RE-IMPLANTATION OF A GORE-TEX SUTURE BUNDLE TWO YEARS LATER WITH AN EXCELLENT OUTCOME AT THE 10 YEARS FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055009 GORE-TEX® SUTURE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Required Intervention