BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORNEAT EVERPATCH

    MDR report key: 20286524 · Received September 23, 2024

    Report

    Report Number
    3029772936-2024-00003
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    August 13, 2024
    Report Date
    October 27, 2024
    Manufacturer
    CORNEAT VISION, LTD.
    Product Code
    QWU
    UDI-DI
    G16010362950
    PMA / PMN Number
    K223074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVER PATCH IS NOT AVAILABLE FOR EVALUATION BY THE MANUFACTURER. THE DEVICE IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. 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).

    Additional Manufacturer Narrative · 0

    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. MANUFACTURER REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2024, A PATIENT UNDERWENT IMPLANTATION OF A GLAUCOMA DRAINAGE DEVICE WITH THE CORNEAT EVER PATCH TO COVER THE TUBE. THE CONJUNCTIVAL EDGE WAS SUTURED WITH A RUNNING VICRYL SUTURE. ONE WEEK POSTOPERATIVELY, THE EYE WAS NOT RE-EPITHELIALIZING AS EXPECTED AND THE PATIENT PRESENTED WITH CONJUNCTIVAL WOUND DEHISCENCE AND GRAFT EXPOSURE. SPECIFICALLY, WOUND DEHISCENCE EXPOSED THE ANTERIOR EDGE OF THE EVER PATCH, BUT THERE WAS NO TUBE EXPOSURE OR WOUND LEAK (SEIDEL NEGATIVE). REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO REPLACE THE PATCH WITH CORNEAL TISSUE. ADDITIONAL PATIENT FOLLOW-UP WAS REQUESTED FROM THE SURGEON ON (B)(6) 2024.

    Description of Event or Problem · 0

    THE PHYSICIAN PROVIDED THE FOLLOWING ADDITIONAL EVENT DETAILS. THE INITIAL GLAUCOMA SHUNT SURGERY WAS PERFORMED ON THE PATIENT'S LEFT EYE WHERE AN AHMED VALVE WAS IMPLANTED IN THE SUPERIOR TEMPORAL QUADRANT. A FORNIX-BASED FLAP WAS CREATED, VICRYL SUTURES WERE USED WITH CONTINUOUS SUTURING TECHNIQUE, THE EVERPATCH WAS NOT TRIMMED, AND CAUTERY WAS APPLIED TO THE SCLERAL BED. APPROXIMATELY ONE MONTH POSTOPERATIVELY THE PATIENT DEVELOPED CONJUNCTIVAL WOUND DEHISCENCE, WITH A NEGATIVE SEIDEL TEST. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, WHERE THE EVERPATCH WAS REPLACED WITH A CORNEAL HALF-MOON PATCH GRAFT. THERE HAS BEEN NO SIGNIFICANT LOSS OF BEST CORRECTED VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066820 CORNEAT EVERPATCH PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT VISION, LTD. 1007691 20230713 G16010362950

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention