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	Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that following a trabecular microbypass stent system procedure, one (1) of two (2) stents was observed "too posterior".Through follow up, it was reported that the stent was believed to be implanted in the suprachoroidal space, though not certain.Per report, the surgeon was struggling with visualization of the angle and trabecular meshwork (tm) and reported difficulty implanting the stents (initially aiming too posterior).The surgeon was able to implant one (1) of two (2) stents.A second device was opened to implant an additional stent, however the surgeon was unable to implant any of the stents from the second device.Subsequently, a third device was used to implant a second stent and completed the procedure.Follow up was requested, and on (b)(6)2025, the following was reported.The posterior stent remained implanted and was confirmed to be in place.The surgeon was content to leave as is.Additional follow up was requested, and on (b)(6) 2025, the following was reported.The stent was believed to be implanted in the suprachoroidal space but is not certain as there was "iris processes" in the way.Reportedly, the patient is "doing well" with the anterior chamber described as "deep and quiet" and visual acuity significantly improved.Trace heme was observed and the patient was placed on cosopt for now.The report noted that a medical expert consultation was offered to the surgeon but was declined.
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 was performed and there were no non-conformities found to be related to the reported event.A review of the device labeling and associated risk documents was completed.Malpositioned stent 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.The reported event (malpositioned stent) 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).

• 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: 21627283
• Report Number: 2032546-2025-00038
• Device Sequence Number: 8219711
• Product Code: OGO
• UDI-Device Identifier: 00853704002319
• UDI-Public: 01008537040023191031591617260831
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P170043
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: G2-W-US
• Device Lot Number: 315916
• 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: 02/26/2025
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2023
• 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
• Patient Sex: Unknown