BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORNEAT EVERPATCH

    MDR report key: 20584618 · Received October 31, 2024

    Report

    Report Number
    3029772936-2024-00012
    Event Type
    Injury
    Date Received
    October 31, 2024
    Date of Event
    August 26, 2024
    Report Date
    October 31, 2024
    Manufacturer
    CORNEAT VISION, LTD.
    Product Code
    QWU
    UDI-DI
    G16010362950
    PMA / PMN Number
    K223074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 WAS CONDUCTED 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 THE 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 CURRENT DEVICE INSTRUCTIONS FOR USE IDENTIFIES THE FOLLOWING POSSIBLE COMPLICATIONS: "DETACHMENT OF THE DEVICE FROM SURROUNDING TISSUE IN CASE OF TRAUMA OR WHEN CHRONIC INFLAMMATION IS NOT ADDRESSED"; AND "CONJUNCTIVAL RETRACTION OR WOUND DEHISCENCE, WHICH MAY LEAD TO EXPOSURE OF THE DEVICE AND COULD REQUIRE A CORRECTIVE PROCEDURE". THE CURRENT INSTRUCTIONS FOR USE ALSO RECOMMENDS "IN THE SHORT TERM AFTER SURGERY, MORE FREQUENT FOLLOW-UP VISITS SHOULD BE CONDUCTED TO ENSURE PROPER WOUND HEALING." MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    CORNEAT RECEIVED A VOLUNTARY MEDWATCH REPORT (#MW5159327) WHICH STATED: "PATIENT UNDERWENT REVISION SURGERY FOR EXPOSED TUBE SHUNT IN THE LEFT EYE, WHICH INVOLVED COVERING THE TUBE WITH A CORNEAT EVERPATCH AND CLOSING CONJUNCTIVA OVER IT. BY POST-OP WEEK #4, IT WAS NOTED THAT THE CONJUNCTIVA HAD RETRACTED AND EXPOSED THE EVERPATCH. THE PATIENT THEREFORE UNDERWENT ANOTHER REVISION SURGERY ON (B) (6) 2024 TO PREVENT INFECTION, DURING WHICH THE EVERPATCH WAS EXPLANTED AND REPLACED WITH AN IRRADIATED DONOR CORNEAL TISSUE." THIS CASE IS RELATED TO MDR #3029772936-2024-00004 AND PROVIDES ADDITIONAL DETAILS ON A SPECIFIC PATIENT FROM THE REPORTED CASES IN THE REFERENCED MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1961602 CORNEAT EVERPATCH PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT VISION, LTD. 1007691 20230713 G16010362950

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| H