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

Model Number	1007691
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ever patch 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.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).
Event or Problem Description
On (b)(6) 2024, a patient underwent implantation of a glaucoma drainage device with the corneat ever patch to cover the tube.The conjunctival edge was sutured with a running vicryl suture.One week postoperatively, the eye was not re-epithelializing as expected and the patient presented with conjunctival wound dehiscence and graft exposure.Specifically, wound dehiscence exposed the anterior edge of the ever patch, but there was no tube exposure or wound leak (seidel negative).Revision surgery was performed on (b)(6) 2024 to replace the patch with corneal tissue.Additional patient follow-up was requested from the surgeon on (b)(6) 2024.
Event or Problem Description
The physician provided the following additional event details.The initial glaucoma shunt surgery was performed on the patient's left eye where an ahmed valve was implanted in the superior temporal quadrant.A fornix-based flap was created, vicryl sutures were used with continuous suturing technique, the everpatch was not trimmed, and cautery was applied to the scleral bed.Approximately one month postoperatively the patient developed conjunctival wound dehiscence, with a negative seidel test.A revision surgery was performed on (b)(6) 2024, where the everpatch was replaced with a corneal half-moon patch graft.There has been no significant loss of best corrected visual acuity.
Additional Manufacturer Narrative
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.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: 20286524
• Report Number: 3029772936-2024-00003
• Device Sequence Number: 20673357
• Product Code: QWU
• UDI-Device Identifier: G16010362950
• UDI-Public: G16010362950
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2024

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: 08/13/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/27/2024
• 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: 66 YR
• Patient Sex: Female
• Patient Race: Black Or African American