MAUDE Adverse Event Report: GLAUKOS CORPORATION ISTENT INFINITE TRABECULAR MICRO-BYPASS SYSTEM; AQUEOUS SHUNT

Model Number	IS3-WW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Seizures, Grand-Mal (2168)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following a right eye (od) trabecular microbypass stent system procedure, the patient presented approximately one (1) year postop with progressive superior visual field loss, described as "mild and non-serious".Per report, the patient resumed medication, and is being monitored.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: the device remains implanted in the patient; therefore, product testing on the actual device could not be performed.The device history record review of the manufacturing lot was performed and there were no non-conformities found to be related to the reported event.A review of the device labeling was completed.Decreased/impaired vision is identified in the labeling as a known inherent risk of trabecular micro-bypass stent procedure.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.An adverse event appears to have occurred, but does not appear to have been a problem with the device or the way it was used.Decreased/impaired vision is an established risk associated with use of the device, which is clearly specified in the product''s labeling.Based on the information received, the root cause of the reported event could not be conclusively identified.Mfr# reference: (b)(4).
Additional Manufacturer Narrative
Mfr# reference: (b)(4).
Event or Problem Description
The following additional information was received.Per report, the patient presented with postoperative visual field loss of greater than or equal to 2.5 decibels (db) in the right eye (od), which was described as "mild" and "non-serious" and was treated with medication.The report noted the event as "persistent".
Additional Manufacturer Narrative
Mfr# reference:(b)(4).
Event or Problem Description
The following additional information was received.Per report, the reported decreased visual remains persistent with "no possible resolution." the report noted that the patient will be monitored after exiting the study.

• Brand Name: ISTENT INFINITE TRABECULAR MICRO-BYPASS SYSTEM
• Common Device Name: AQUEOUS SHUNT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• Manufacturer (Section G): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: brittany massey ; 229 avenida fabricante; san clemente, CA 92672 ; 949367960
• MDR Report Key: 18120592
• Report Number: 2032546-2023-00131
• Device Sequence Number: 12638346
• Product Code: KYF
• UDI-Device Identifier: 00853704002470
• UDI-Public: 0100853704002470
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K220032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2025

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: 08/31/2022
• Device Model Number: IS3-WW
• Device Lot Number: 112718
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/23/2025; 02/21/2025
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/29/2025; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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