MAUDE Adverse Event Report: GLAUKOS CORPORATION ISTENT INJECT W TRABECULAR MICRO BYPASS SYSTEM; INTRAOCULAR PRESSURE LOWERING IMPLANT

Model Number	G2-W-US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: the device was not available; therefore, product testing on the actual device could not be performed.The device history record review of the manufacturing lot, including relevant sterilization records, was performed and there were no non-conformities found to be related to the reported event.A review of the risk management file was completed.The reported event is a known inherent risk of trabecular micro-bypass stent procedure.The ifu adequately provides instructions, 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.The reported event (peripheral anterior synechiae) is an established risk associated with use of the device.Based on the information received, the root cause of the reported event could not be conclusively identified.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that following a right eye (od) cataract plus trabecular microbypass stent system procedure, the patient presented approximately two and a half (2.5) months postop with peripheral anterior synechiae (pas) described as "mild and non-serious".Per report, the pas was treated with medication with "no possible resolution".The most recent follow-up examination noted the stent was visible in the original implant location.Additional information is being requested.
Additional Manufacturer Narrative
Additional information: b2, b5, b6, g2, g3.Mfr# reference:(b)(4).
Event or Problem Description
The following additional information was obtained.Reportedly, approximately 22 month postoperative the patient's intraocular pressure (iop) was "not at target" and required surgical intervention.Per report, selective laser trabeculoplasty (slt) was performed and the event was noted as "resolved" and was reported to be unlikely related.

• Brand Name: ISTENT INJECT W TRABECULAR MICRO BYPASS SYSTEM
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• 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: 17638274
• Report Number: 2032546-2023-00091
• Device Sequence Number: 18046859
• Product Code: OGO
• UDI-Device Identifier: 00853704002319
• UDI-Public: 0100853704002319
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P170043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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 Expiration Date: 07/31/2024
• Device Model Number: G2-W-US
• Device Lot Number: 111514
• 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: 03/14/2025
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• 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: 76 YR
• Patient Sex: Female