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

Model Number	IS3-AU
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: h6-(investigation type 5): b13.The device was returned with the injector nested in the thermoform packaging tray, and three (3) stents were returned.The device evaluation was completed, and the injector's trocar was found unseated from the carrier retention finger.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 complaint history review was completed.The electronic complaint system was searched for the specified lot#.There was one similar issue reported for this lot #.A review of the device labeling including the risk analysis was completed.The reported issue is adequately captured on the product risk assessment.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Based on the device evaluation findings, customer's reported issued was confirmed; however, the root cause of the unseated trocar was not conclusively identified.Mfr# reference: (b)(4).
Event or Problem Description
It was initially reported that during attempt to implant the first stent from a trabecular microbypass stent system, the surgeon noticed that the trocar appeared "bent", and the stent remained on the trocar.Per report, the surgeon believed the trocar was "damaged" and used a second device to complete the procedure with no report of patient injury.Through follow-up, the following additional information was received.Per report, the surgeon reported an uneventful procedure and reiterated that a new device used to complete the procedure.Reportedly, the surgeon does not believe there were any preoperative or postoperative factors during device handling that contributed to the event.The report noted that there was no adverse patient impact or intervention required and the event is resolved.The patient status was described as "fine" after the new device was used.

• 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: 25046387
• Report Number: 2032546-2026-00030
• Device Sequence Number: 9643158
• Product Code: KYF
• UDI-Device Identifier: 00853704002470
• UDI-Public: 01008537040024701032961617270630
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K220032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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-AU
• Device Lot Number: 329616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• 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 Age: 79 YR
• Patient Sex: Female