CORNEAT EVERPATCH
Report
- Report Number
- 3029772936-2024-00004
- Event Type
- Injury
- Date Received
- September 27, 2024
- Date of Event
- February 25, 2025
- Report Date
- April 7, 2025
- Manufacturer
- CORNEAT VISION, LTD.
- Product Code
- QWU
- PMA / PMN Number
- K223074
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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 AUTHORS REPORT THAT A SUBSET OF THE EXPLANTED EVERPATCH SAMPLES (N = 5) WERE SUBJECTED TO ANALYSIS TO ASSESS TISSUE INTEGRATION. THE METHODS AND FINDINGS ARE DESCRIBED IN THE ATTACHED ARTICLE. THE AUTHORS REPORT THAT THE CASES DESCRIBED CONFORMED TO THE MANUFACTURER'S INSTRUCTIONS FOR USE WITH THE EXCEPTION THAT WETFIELD CAUTERY WAS USED TO ACHIEVE HEMOSTASIS. THE AUTHORS CONCLUDED THAT TUBE SHUNT IMPLANTATION IN PATIENTS USING CORNEAT EVERPATCH AS A MATERIAL TO COVER THE TUBE SHUNT MATERIAL WAS ASSOCIATED WITH A HIGHER RATE OF PATCH EXPOSURE AND A HIGHER SURGICAL REVISION RATE COMPARED WITH IRRADIATED DONOR HUMAN CORNEA. KANTER J, GARKAL A, CARDAKLI N, PITHA I, SABHARWAL J, SCHEIN OD ET AL. EARLY POSTOPERATIVE CONJUNCTIVAL COMPLICATIONS LEADING TO EXPOSURE OF SURGICALLY IMPLANTED CORNEAT EVERPATCH DEVICES. OPHTHALMOLOGY. 2025;MAR 3:S0161-6420(25)00141-1. EPUB AHEAD OF PRINT. DOI:10.1016/J.OPHTHA.2025.02.020. MANUFACTURER REFERENCE #: (B)(4).
THE PATIENT AND DEVICE IDENTIFIERS WERE NOT DISCLOSED TO CORNEAT AND THE MEDWATCH REPORT LACKS SUFFICIENT INFORMATION TO UNDERSTAND THE EVENT DETAILS OR ETIOLOGY. 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).
CORNEAT VISION BECAME AWARE OF NEW EVENT DETAILS FROM A RETROSPECTIVE CONSECUTIVE COMPARISON STUDY PUBLISHED ONLINE WHICH REPORTED SAFETY OUTCOMES OF THE CORNEAT EVERPATCH AND HUMAN DONOR CORNEA. THE STUDY AUTHORS REPORT THAT OUT OF 29 PATIENTS WHO UNDERWENT GLAUCOMA TUBE SHUNT IMPLANTATION OR REVISION WHERE THE EVERPATCH WAS USED TO COVER THE TUBE, 13 PATIENTS EXPERIENCED EARLY EVERPATCH EXPOSURE, AND 8 PATIENTS REQUIRED A RETURN TO THE OPERATING ROOM FOR REVISION SURGERY. THE EXPOSURES ALL OCCURRED WITHIN 5 MONTHS OF SURGERY. IN ALL CASES, THE REVISION INCLUDED EXPLANTATION OF THE EVERPATCH, REPLACEMENT WITH A HUMAN DONOR CORNEAL PATCH GRAFT, AND RECLOSURE OF THE CONJUNCTIVA. IN MOST CASES, SURGICAL REVISION WAS DEEMED NONURGENT DUE TO LACK OF SEIDEL POSITIVITY AND SURGEONS OPTED INITIALLY TO OBSERVE, TO DETERMINE IF CONJUNCTIVA WOULD RE-EPITHELIALIZE TO COVER OR FORM A SEAL WITH THE PATCH GRAFT. AT NO POINT DID ANY PATIENT MANIFEST SIGNS OR SYMPTOMS OF INFECTION. NO CASES OF WOUND LEAK, TUBE SHUNT DEVICE EXPOSURE, OR INFECTION OCCURRED.
ON AUGUST 28, 2024, THE MANUFACTURER BECAME AWARE OF SERIOUS INJURIES INVOLVING THE EVERPATCH DEVICES WHICH WERE IMPLANTED IN CONJUNCTION WITH GLAUCOMA TUBE SHUNTS. SPECIFICALLY, 2 PATIENTS AT THIS CLINIC PRESENTED WITH EARLY WOUND DEHISCENCE, CONJUNCTIVAL EROSION, AND EXPOSURE OF THE EVERPATCH DEVICE. BOTH PATIENTS UNDERWENT SURGICAL REVISION. THE PHYSICIAN ALSO REPORTED THAT 2 OTHER PATIENTS AT THEIR CLINIC WERE CURRENTLY SCHEDULED FOR REVISION SURGERY, BUT THERE HAS BEEN NO CONFIRMATION. NO SPECIFIC PATIENT OR DEVICE INFORMATION WAS PROVIDED AND THE PHYSICIAN STATED THAT A MEDWATCH REPORT WOULD BE FILED WITH FDA THAT WOULD DISCLOSE THE EVENT DETAILS. ON AUGUST 30, 2024, THE MANUFACTURER BECAME AWARE OF A VOLUNTARY MEDWATCH REPORT (MW5159061) FILED WITH FDA THAT MATCHED THE DESCRIPTION OF THE EVENT REPORTED. THE MEDWATCH REPORT STATED: "OVER THE PAST 6 MONTHS, 3 (B)(6) DOCTORS HAVE PERFORMED A TOTAL OF 29 TUBE SHUNT IMPLANTATION SURGERIES USING THE CORNEAT EVERPATCH TO COVER THE TUBE. THIS IS AN FDA 510(K) CLEARED DEVICE MARKETED FOR USE IN CONJUNCTION WITH GLAUCOMA TUBE SHUNT IMPLANTATION OR TUBE REVISION PROCEDURES. AMONGST THIS COHORT OF PATIENTS, WE HAVE OBSERVED CONJUNCTIVAL RETRACTION AND EROSION WITH EXPOSURE OF THE EVERPATCH IN 9 PATIENTS (31%). OF THOSE, 4 HAVE COMPLETED OR ARE SCHEDULED FOR REVISION SURGERY DUE TO EITHER DISLOCATION OF THE EVERPATCH ONTO THE CORNEAL SURFACE OR PROGRESSIVELY INCREASING EXPOSURE OF THE EVERPATCH WITHOUT EPITHELIALIZATION. THIS RATE OF CONJUNCTIVAL RETRACTION AND PATCH EXPOSURE (REQUIRING RETURN TO OPERATING ROOM) IS DRAMATICALLY HIGHER THAN WHAT WE HAVE BEEN SEEING PREVIOUSLY WITH SPLIT THICKNESS CORNEAL HALF-MOON PATCH GRAFTS OR TUTOPLAST GRAFTS, AND WE ARE CONCERNED THERE MAY BE A PROBLEM WITH USING THIS DEVICE AS A PATCH FOR TUBE SHUNT SURGERY. I APOLOGIZE THAT I HAVE NOT PRE-POPULATED THE PATIENT INFORMATION THAT YOU ARE ASKING FOR INTO THIS FORM, BUT SINCE WE HAVE 9 PATIENTS, THERE WAS NO EASY WAY FOR ME TO DO THIS. IF YOU FOLLOW-UP WITH ME, I CAN PROVIDE A SPREADSHEET WHICH HAS THIS INFORMATION FOR ALL 29 PATIENTS THAT RECEIVED THE EVERPATCH, INCLUDING THE 9 THAT HAVE EXPERIENCED EXPOSURES." ADDITIONAL PATIENT FOLLOW-UP WAS REQUESTED FROM THE SURGEON ON AUGUST 29, 2024, SEPTEMBER 5, 2024, AND SEPTEMBER 8, 2024. AT THIS TIME NO ADDITIONAL INFORMATION HAS BEEN RECEIVED IN ORDER TO UNDERSTAND THE DETAILS OF THE 2 REPORTABLE EVENTS WHERE SECONDARY SURGICAL INTERVENTION WAS PERFORMED OR THE OTHER 2 POSSIBLE REPORTABLE EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1709921 | CORNEAT EVERPATCH | PROSTHESIS, EYELID SPACER/GRAFT, POLYMER | QWU | CORNEAT VISION, LTD. | 1007691 | 20230713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| R | AHMED FP7| BAERVELDT-250| BAERVELDT-350 |