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

Model Number	1007691
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
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.A capa investigation was conducted 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 the 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 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).
Event or Problem Description
Corneat received a voluntary medwatch report (#mw5159327) which stated: "patient underwent revision surgery for exposed tube shunt in the left eye, which involved covering the tube with a corneat everpatch and closing conjunctiva over it.By post-op week #4, it was noted that the conjunctiva had retracted and exposed the everpatch.The patient therefore underwent another revision surgery on (b) (6) 2024 to prevent infection, during which the everpatch was explanted and replaced with an irradiated donor corneal tissue." this case is related to mdr #3029772936-2024-00004 and provides additional details on a specific patient from the reported cases in the referenced mdr.

• 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: 20584618
• Report Number: 3029772936-2024-00012
• Device Sequence Number: 21011080
• Product Code: QWU
• UDI-Device Identifier: G16010362950
• UDI-Public: +G16010362950/$20230713/14D202501131
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K223074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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?: No
• 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: 10/01/2024
• Initial Report FDA Received Date: 10/31/2024
• 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; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White