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

Model Number	IS3-WW
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
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.Dislodged/dislocated 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.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.Dislodged/dislocated 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).
Event or Problem Description
It was reported that following a right eye (od) trabecular microbypass stent system procedure, the patient presented on postoperative day one (1) with a dislodged stent in the anterior chamber, which required surgical intervention to remove the dislodged stent.Per report, the patient has two (2) remaining well-implanted stents.Additional information has been requested.
Event or Problem Description
Through follow-up, the following additional information was received.Per report, postoperative visualization of the stent was described as "a loose stent in the anterior chamber (ac)" which was removed on postoperative day one (1).Reportedly, the surgeon believes "the stent may not have been properly positioned during the procedure", which may have contributed to the dislodged stent.The report noted that the stent's positioning did not result in any adverse patient impact or further intervention, and the event has resolved.
Additional Manufacturer Narrative
Additional information: b5, g2, g3.Mfr# reference: (b)(4).

• 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: 22865394
• Report Number: 2032546-2025-00085
• Device Sequence Number: 18048042
• Product Code: KYF
• UDI-Device Identifier: 00853704002470
• UDI-Public: 01008537040024701032592917270228
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K220032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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 Model Number: IS3-WW
• Device Lot Number: 325929
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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