MAUDE Adverse Event Report: CORNEAT VISION, LTD. CORNEAT EVERPATCH; PROSTHESIS, EYELID SPACER/GRAFT, POLYMER

Model Number	1007691
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, a patient with neovascular glaucoma underwent implantation of the ahmed glaucoma valve in the right eye and the everpatch device was used to cover the tube where the tube was placed in the ciliary sulcus.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 interrupted sutures.At the 3-month postoperative examination on (b)(6) 2024, everything looked good including the everpatch.However, at the 6-month examination on (b)(6) 2024, the patient presented with exposure of the anterior temporal corner of the everpatch.There was no wound leak (seidel negative).On (b)(6) 2024, tube revision surgery was performed; the everpatch was explanted and replaced with a corneal patch graft.During explantation, the everpatch was not incorporated into the tenons, except for the posterior 2 suture holes and posterior edge of the graft.The entire anterior portion of the of the patch was free and mobile under the conjunctiva.The temporal edge of the everpatch was closest to the limbus.The surgeon suspects movement of the patch likely contributed to the conjunctival erosion.Preoperatively, the patient had very low vision with a best corrected visual acuity (bcva) of counting fingers (cf).In the early postoperative period, bcva decreased to light perception (lp).The surgeon attributed the poor vision to her preexisting conditions (neovascular glaucoma due to central retinal artery occlusion and uncontrolled intraocular pressure).
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 patient's underlying advanced disease and ischemia likely predisposed the event.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).

• Brand Name: CORNEAT EVERPATCH
• Common Device Name: PROSTHESIS, EYELID SPACER/GRAFT, POLYMER
• Manufacturer (Section D): CORNEAT VISION, LTD.; 4 hasheizaf st.; raanana, central 43664 11; IS 4366411
• Manufacturer (Section G): CORNEAT VISION, LTD.; 4 hasheizaf st.; raanana, central 43664 11; IS 4366411
• Manufacturer Contact: benjamin bernstein ; 4 hasheizaf st.; raanana, central 43664-11 ; IS 4366411
• MDR Report Key: 20340225
• Report Number: 3029772936-2024-00006
• Device Sequence Number: 8054963
• Product Code: QWU
• UDI-Device Identifier: G16010362950
• UDI-Public: +G16010362950/$20230713/14D202501131
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K223074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2025
• Device Model Number: 1007691
• Device Catalogue Number: 1036295
• Device Lot Number: 20230713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2024
• Initial Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White