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

Model Number	IS3-AU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyphema (1911); Intraocular Pressure Increased (1937); Visual Impairment (2138)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
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 is currently underway.A review of the device labeling and associated risk documents was completed.Hyphema, elevated iop and decreased/impaired vision are identified in the labeling as known inherent risks 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.Hyphema, elevated iop and decreased/impaired vision are established risks 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; however, the report noted that the event was likely due to the patient's antiplatelet medication.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that following a successful trabecular microbypass stent system procedure with the implantation of three (3) well placed stents, a patient who is on antiplatelet medication presented on postoperative day one (1) with what was described as a "large" hyphema" associated with elevated intraocular pressure and "hand motion" vision.Reportedly, the patient was referred to a tertiary hospital for an anterior chamber (ac) washout to treat the hyphema.The report noted that the hyphema is believed to be due to the patient's antiplatelet medication and the surgeon is seeking counsel.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, b6, g2, g3.Mfr# reference: (b)(4).
Event or Problem Description
Through follow-up, the following additional information was received.Per report, it is believed that the patient is doing well following the anterior chamber washout, with the bleeding resolved and the intraocular pressure decreased.
Additional Manufacturer Narrative
Additional information: d4 (exp.Date, serial #, udi#), g2, g3, h4.Correction: d4 (model#).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.Mfr# reference: (b)(4).

• Brand Name: ISTENT INFINITE TRABECULAR MICRO-BYPASS SYSTEM
• Common Device Name: AQUEOUS SHUNT
• Manufacturer (Section D): GLAUKOS CORPORTATION; 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: 22019080
• Report Number: 2032546-2025-00059
• Device Sequence Number: 9484325
• Product Code: KYF
• UDI-Device Identifier: 00853704002470
• UDI-Public: 01008537040024701032357917261031
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K220032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2025

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 Model Number: IS3-AU
• Device Lot Number: 323579
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 05/16/2025; 06/19/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/10/2025; 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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
• Patient Sex: Male