BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORNEAT EVERPATCH

    MDR report key: 19295720 · Received May 12, 2024

    Report

    Report Number
    3029772936-2024-00001
    Event Type
    Injury
    Date Received
    May 12, 2024
    Date of Event
    April 8, 2024
    Report Date
    May 12, 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 EVERPATCH REMAINS IMPLANTED IN THE PATIENT AND 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. THE PATCH WAS WELL INTEGRATED WITH THE CONJUNCTIVA AND THERE IS NO INFORMATION TO SUGGEST A DEVICE MALFUNCTION. THE SURGEON SUSPECTS THERE COULD BE OTHER PATIENT-RELATED MEDICAL CONSIDERATIONS THAT MAY HAVE PREDISPOSED THIS EVENT, BUT THE EXACT CAUSE OF THE EVENT IS NOT KNOWN. CONJUNCTIVAL DEHISCENCE IS A COMMON POSTOPERATIVE ADVERSE EVENT AND AN INHERENT RISK OF GLAUCOMA DRAINAGE DEVICE IMPLANTATION. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A POTENTIAL QUALITY ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. 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

    A PATIENT UNDERWENT GLAUCOMA SURGERY IN LATE (B)(6) /EARLY (B)(6) 2024 WITH IMPLANTATION OF AN AHMED GLAUCOMA VALVE WHERE THE CORNEAT EVERPATCH WAS USED TO REINFORCE THE SCLERA AND AID THE PHYSICAL RECONSTRUCTION OF THE OCULAR SURFACE. APPROXIMATELY 2 MONTHS POSTOPERATIVELY THE SURGEON OBSERVED CONJUNCTIVAL DEHISCENCE WITH PARTIAL EXPOSURE OF THE EVERPATCH. ALTHOUGH THERE WAS NO TUBE EXPOSURE AND NO WOUND LEAK, THE SURGEON ELECTED TO SCHEDULE CORRECTIVE SURGERY TO ROTATE THE FLAP INFERIORLY AND RE-SUTURE TO COVER THE EXPOSED AREA. AFTER THE INTERVENTION, THE SURGEON REPORTED OBSERVING THAT THE PATCH WAS WELL INTEGRATED WITH THE CONJUNCTIVA. THE SUTURES WERE NOT DIRECTLY PLACED OVER THE PATCH. ADDITIONAL PATIENT FOLLOW-UP WAS REQUESTED FROM THE SURGEON AND ON (B)(6) 2024 (3 WEEKS AFTER SURGICAL INTERVENTION), THE SURGEON RESPONDED THAT THE PATIENT HAS BEEN DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744033 CORNEAT EVERPATCH PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT VISION, LTD. 1007691 20230713 G16010362950

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention