BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX® SUTURE

    MDR report key: 24307165 · Received February 10, 2026

    Report

    Report Number
    3003910212-2026-01637
    Event Type
    Injury
    Date Received
    February 10, 2026
    Date of Event
    November 26, 2024
    Report Date
    February 10, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    GAW
    PMA / PMN Number
    P820083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    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. A2 - A4: AGE, DATE OF BIRTH AND WEIGHT WERE REQUESTED, BUT NOT PROVIDED. B3: DATE OF EVENT, DATE OF IMPLANT/EXPLANT WAS REQUESTED, BUT NOT PROVIDED, THEREFORE THE DATE THE ARTICLE WAS AVAILABLE ONLINE (NOVEMBER 26TH, 2024) WILL BE USED. H3: REVIEW OF THE MANUFACTURING RECORDS AND ENGINEERING EVALUATION COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED AND THE DEVICE WAS NOT RETURNED TO GORE. H6 - CODE B13: ADDITIONAL INFORMATION REGARDING THE EVENT WAS REQUESTED FROM THE COMPLAINANT, BUT NO RESPONSE WAS RECEIVED. THE GORE-TEX® SUTURE INSTRUCTIONS FOR USE (IFU) STATES: CONTRAINDICATIONS: THIS DEVICE IS CONTRAINDICATED FOR USE IN OPHTHALMIC SURGERY, MICROSURGERY, AND PERIPHERAL NEURAL TISSUE. 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 LITERATURE PUBLICATION WAS REVIEWED: ¿UNBURIED POLYTETRAFLUOROETHYLENE SCLERAL SUTURE EROSIONS AND FAILURE OF PERICARDIAL GRAFT REVISION.¿ HTTPS://DOI.ORG/10.1016/J.AJOC.2024.102223. AMERICAN JOURNAL OF OPHTHALMOLOGY CASE REPORTS 36 (2024) 102223. THE ARTICLE WAS AVAILABLE ONLINE NOVEMBER 26, 2024. THE OBJECTIVE OF THIS CASE SERIES WAS TO REPORT THE PRESENTATION AND MANAGEMENT OF EXPOSED, UNBURIED POLYTETRAFLUOROETHYLENE GORE-TEX® SUTURE (CV-8) USED IN SCLERAL FIXATION OF INTRAOCULAR LENSES, WITH PARTICULAR EMPHASIS ON THE PERFORMANCE OF PERICARDIAL PATCH GRAFTS COMPARED WITH IRRADIATED CORNEAL PATCH GRAFTING. THE STUDY INVOLVED THREE PATIENTS WITH SUTURE EXPOSURE FOLLOWING SCLERAL-FIXATED INTRAOCULAR LENS IMPLANTATION FOR UNDERLYING OPHTHALMIC DISEASE. ALL CASES INVOLVED THE USE OF GORE-TEX CV-8 SUTURES, AND THE INTRAOCULAR LENSES USED WERE AKREOS MODELS FROM BAUSCH + LOMB. THE STUDY POPULATION CONSISTED OF THREE EYES WITH PRIOR OCULAR COMORBIDITIES SUCH AS PTERYGIUM EXCISION, HSV KERATITIS WITH KERATOPLASTY, COMPLICATED CATARACT SURGERY, CORNEAL EDEMA, AND CYSTOID MACULAR EDEMA. ALL PATIENTS UNDERWENT REVISION SURGERY WITH PERICARDIAL GRAFT PATCHING TO COVER THE EXPOSED GORE-TEX SUTURES. EACH CASE SUBSEQUENTLY EXPERIENCED GRAFT FAILURE WITHIN MONTHS, RESULTING IN RECURRENT SUTURE EXPOSURE. ONE PATIENT LATER UNDERWENT REPAIR WITH AN IRRADIATED CORNEAL PATCH GRAFT, WHICH SUCCESSFULLY MAINTAINED SUTURE COVERAGE OVER A LONG-TERM FOLLOW-UP PERIOD EXCEEDING ONE YEAR. THE PRIMARY OUTCOMES DEMONSTRATED THAT PERICARDIAL GRAFTING WAS NOT DURABLE FOR CORRECTING EXPOSED GORE-TEX SUTURES, WHEREAS AN IRRADIATED CORNEAL GRAFT PROVIDED SUSTAINED COVERAGE IN THE ONE CASE WHERE IT WAS APPLIED. SAFETY EVENTS INCLUDED RECURRENT SUTURE EROSION, DISCOMFORT, OCULAR INFLAMMATION, AND THE NEED FOR ADDITIONAL PROCEDURES; HOWEVER, NO SIGHT-THREATENING INFECTIONS DIRECTLY ATTRIBUTABLE TO THE GRAFT WERE REPORTED. THE ARTICLE REPORTED SUTURE EROSION / SUTURE EXPOSURE THROUGH CONJUNCTIVA IN ALL THREE CASES. ALL THREE CASES REQUIRED RETURN TO THE OPERATING ROOM FOR REVISION PROCEDURES. ONE PATIENT ULTIMATELY REQUIRED INTRAOCULAR LENS EXPLANTATION DUE TO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363831 GORE-TEX® SUTURE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW W. L. GORE & ASSOCIATES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R