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

Model Number	IS3-WW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trocar broke following the implantation of the second stent of three (3) stents from a trabecular microbypass stent system.Per report, the fragment was removed intraoperatively from the operative eye with no report of adverse patient impact.The report noted that obscured visualization and surgical technique contributed to the event, and that the event is resolved with the patient's intraocular pressure (iop) "controlled".Additional information has been requested.
Additional Manufacturer Narrative
Additional information: h6:(type of investigation 4)- b11.The device is expected to be returned for evaluation but has not been received at glaukos evaluation center.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 complaint history review was completed.The electronic complaint system was searched for the specified lot#.There were no similar issues reported for this lot #.A review of the surgical video was completed, and the reported issue of a trocar fracture could not be conclusively confirmed based on the video quality and the limited visualization through the gonioscope lens.Notably, there appeared to be trocar bias prior to stent deployment, which may indicate that surgical technique was a contributing factor.A review of the device labeling including the risk analysis was completed.The reported issue (trocar fragmentation) is identified to be an anticipated hazard.The residual risk for each potential harm was found to be within the insignificant risk region.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Mfr# reference: 47310.
Additional Manufacturer Narrative
The injector was returned nested in the unsealed thermoform packaging tray, and no stents were returned.The device evaluation was completed, and the trocar was found bent, not broken, as reported.This finding likely occurred during the surgical procedure.No non-conformances were found.Based on these findings, the customer's reported issue of a broken trocar was not confirmed, and the root cause of the bent trocar was not conclusively identified.The additional information identified through device evaluation was reassessed for reportability criteria; and concluded that the reported event no longer meets the statutory definition of a medical device reportable event.Based on the new information, glaukos no longer considers this report as a reportable event.Mfr# reference: (b)(4).
Event or Problem Description
Through follow-up, the following additional information was received from the surgeon.Per report, during the patient's left eye (os) procedure "everything was looking good", but "then went to press" and the tip broke.The patient's current status was reported as intraocular pressure (iop) is "on target" and "good" with one (1) medication, and the patient still being monitored.The report noted that there was no adverse patient impact or intervention needed.

• 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: 24048404
• Report Number: 2032546-2026-00002
• Device Sequence Number: 13188561
• Product Code: KYF
• UDI-Device Identifier: 00853704002470
• UDI-Public: 01008537040024701032905417270430
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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-WW
• Device Lot Number: 329054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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: 64 YR
• Patient Sex: Male