EVERPATCH+

Description of Event or Problem

ON (B)(6) 2025, A PATIENT WITH GLAUCOMA UNDERWENT IMPLANTATION OF THE AHMED GLAUCOMA VALVE IN THE RIGHT EYE AND THE EVERPATCH+ WAS USED TO COVER THE TUBE. A FORNIX-BASED FLAP WAS CREATED AND THE GLAUCOMA VALVE WAS IMPLANTED IN THE SUPERIOR TEMPORAL QUADRANT; CAUTERY WAS USED INTRAOPERATIVELY TO CONTROL BLEEDING AND MINIMIZE SCARRING. SURGERY WAS UNEVENTFUL AND THE WOUND WAS CLOSED WITH VICRYL CONTINUOUS SUTURES. TOPICAL STEROIDS WERE PRESCRIBED POSTOPERATIVELY (PER STANDARD OF CARE). WITHIN THE FIRST POSTOPERATIVE MONTH, THE PATIENT PRESENTED WITH EXPOSURE OF THE CONJUNCTIVA OVER THE EVERPATCH+; HOWEVER, THERE WAS NO WOUND LEAK (I.E., SEIDEL NEGATIVE). ON (B)(6) 2025, TUBE REVISION SURGERY WAS PERFORMED WHERE THE EVERPATCH+ WAS EXPLANTED AND REPLACED WITH A TUTOPLAST. DURING EXPLANTATION, THE EVERPATCH+ WAS NOT WELL ADHERENT AND WAS EASILY REMOVED. THE SURGEON SUSPECTS THAT THE PATIENT'S VERY THIN CONJUNCTIVA (NO TENON'S) LIKELY CONTRIBUTED TO THE CONJUNCTIVAL EROSION. THE PATIENT HAS NOT EXPERIENCED A LOSS OF 2 OR MORE LINES OF BEST CORRECTED VISUAL ACUITY (BCVA) COMPARED TO BASELINE.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. THE EXPLANTED DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION IS UNDERWAY TO EVALUATE THE RATE OF WOUND DEHISCENCE AND EXPOSURE ASSOCIATED WITH EVERPATCH+. BASED ON CURRENT DATA, THIS IS THE ONLY KNOWN CASE OF EVERPATCH+ EXPOSURE. 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).