BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORNEAT EVERPATCH

    MDR report key: 20349419 · Received October 1, 2024

    Report

    Report Number
    3029772936-2024-00008
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    June 1, 2024
    Report Date
    October 1, 2024
    Manufacturer
    CORNEAT VISION, LTD.
    Product Code
    QWU
    UDI-DI
    G16010362950
    PMA / PMN Number
    K223074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. A CAPA INVESTIGATION HAS BEEN OPENED TO UNDERSTAND THE EVERPATCH RATE OF WOUND DEHISCENCE, CONJUNCTIVAL EROSION, EVERPATCH EXPOSURE, AND SURGICAL INTERVENTION AND TO UNDERSTAND HOW THIS CORRELATES WITH ALTERNATIVE TREATMENTS FOR SCLERAL REINFORCEMENT TO COVER GLAUCOMA DRAINAGE TUBES (E.G., DONOR TISSUE, PERICARDIUM, OR SCLERAL TUNNEL). THE MAJORITY OF EVERPATCH CUSTOMERS WERE CONTACTED AND ASKED TO SHARE THEIR POSTOPERATIVE CLINICAL EXPERIENCE. BASED ON PRELIMINARY CAPA INVESTIGATION RESULTS, CORNEAT ESTIMATES THE LIKELIHOOD OF OCCURRENCE FOR WOUND DEHISCENCE IS 10-15%, WITH ALL KNOWN CASES BEING SEIDEL NEGATIVE (I.E., NO WOUND LEAK). HOWEVER, SURGEONS OPTED TO PERFORM REVISION SURGERY IN APPROXIMATELY 5-10% OF IMPLANTED PATIENTS. EARLY FINDINGS ALSO SHOW CONJUNCTIVAL EROSIONS HEALED SPONTANEOUSLY (I.E., WITHOUT SURGICAL INTERVENTION) IN APPROXIMATELY 1-5% OF IMPLANTED PATIENTS. IMPORTANTLY, THERE HAVE BEEN NO CONFIRMED REPORTS OF GLAUCOMA DEVICE/TUBE EXPOSURE. THESE CURRENT ADVERSE EVENT RATES FOR THE EVERPATCH COMPARE FAVORABLY TO PUBLISHED RATES FOR WOUND DEHISCENCE USING TISSUE TO COVER THE GLAUCOMA TUBE. GEFFEN ET AL REPORT: "CONJUNCTIVAL DEHISCENCE IS USUALLY A BENIGN, COMMON COMPLICATION AFTER AGV [AHMED GLAUCOMA VALVE] INSERTION. IT DOES NOT NEED REPAIR AS LONG AS THE TUBE IS WELL COVERED. AGV TUBE OR PLATE EXPOSURES ARE LESS COMMON, OCCUR LATER AND WERE PROMPTLY REPAIRED AS PER CURRENT PRACTICE." THE AUTHORS REVIEWED THE MEDICAL CHARTS OF 158 SUBJECTS AND REPORT 33.5% OF SUBJECTS PRESENTED WITH WOUND DEHISCENCE AND 8.9% OF SUBJECTS PRESENTED WITH GLAUCOMA DEVICE EXPOSURES. THERE WERE NO CONJUNCTIVAL COMPLICATIONS IN 57.6% OF SUBJECTS. REFERENCE: GEFFEN N, BUYS YM, SMITH M, ANRAKU A, ALASBALI T, RACHMIEL R ET AL. CONJUNCTIVAL COMPLICATIONS RELATED TO AHMED GLAUCOMA VALVE INSERTION. J GLAUCOMA. 2014;23(2):109-14. CONJUNCTIVAL DEHISCENCE IS A COMMON POSTOPERATIVE ADVERSE EVENT AND AN INHERENT RISK OF GLAUCOMA DRAINAGE DEVICE IMPLANTATION. THE DEVICE INSTRUCTIONS FOR USE IDENTIFIES THE FOLLOWING POSSIBLE COMPLICATION: DETACHMENT OF THE DEVICE FROM SURROUNDING TISSUE IN CASE OF TRAUMA OR WHEN CHRONIC INFLAMMATION IS NOT ADDRESSED. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2024, A PATIENT WITH GLAUCOMA UNDERWENT IMPLANTATION OF THE AHMED GLAUCOMA VALVE IN THE RIGHT EYE AND THE EVERPATCH DEVICE WAS USED TO COVER THE TUBE (SULCUS TUBE PLACEMENT). A FORNIX-BASED FLAP WAS CREATED, AND THE GLAUCOMA VALVE WAS IMPLANTED IN THE INFERIOR NASAL QUADRANT AND SECURED WITH VICRYL INTERRUPTED SUTURES. THE SEIDEL TEST WAS NEGATIVE AT THE END OF SURGERY (I.E., NO WOUND LEAK). APPROXIMATELY 2 WEEKS POSTOPERATIVELY, THE PATIENT PRESENTED WITH WOUND DEHISCENCE AND EXPOSURE OF 2/3 OF THE EVERPATCH. THE PATIENT UNDERWENT SURGICAL REVISION WITH EXTENSIVE DISSECTION AND CONJUNCTIVAL MOBILIZATION. THE EVERPATCH WAS CORRECTED BY ADVANCING HEALTHY CONJUNCTIVA TO COVER THE ENTIRE PATCH, ENSURING CLOSURE WITHOUT UNDUE TENSION AND REINFORCED WITH TWO 10-0 NYLON MATTRESS SUTURES AT THE LIMBUS. THE PATIENT PRESENTED WITH RECURRENT WOUND DEHISCENCE 2 WEEKS FOLLOWING THE REVISION WITH EXPOSURE OF 1/3 OF THE EVERPATCH. THE PATIENT IS CURRENTLY STABLE WITH A NEGATIVE SEIDEL TEST (I.E., NO WOUND LEAK). FURTHER REVISION SURGERY IS NOT VIABLE DUE TO THE CURRENT STATE OF THE CONJUNCTIVA, AND THE SURGEON IS MONITORING THE PATIENT FOR RE-EPITHELIALIZATION. THE SURGEON SUSPECTS THE ISSUE MAY HAVE OCCURRED DUE TO EYE RUBBING OR POOR CONJUNCTIVAL CONDITION, AS THE PATIENT HAD UNDERGONE SEVERAL PREVIOUS SURGERIES (REFER TO B7 FOR DETAILS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007073 CORNEAT EVERPATCH PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT VISION, LTD. 1007691 20230713 G16010362950

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention