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

Model Number	IS3-AU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Intraocular Pressure Increased (1937)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: the device remains implanted in the patient; 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 was completed.Eye injury 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.Eye injury 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; however, the report noted that inadvertent contact of the injector with the iris contributed to the event.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 postop day one (1) with pupil distortion and the iris pulled "nasally".Per report, the patient's intraocular pressure is stable with mild red blood cells in the anterior chamber (ac), visual acuity (va) "ok", and no residual ophthalmic viscosurgical device (ovd).The report noted that injector contact with the midperipheral iris during the procedure may have contributed to the event.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: a1, a2, a6, b5, b6, b7, g2, g3.A review of the device labeling was completed.Iop increase 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.Iop increase 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 (iop increase) could not be conclusively identified, however the report noted that the surgeon believes it was due to a steroid response.Mfr# reference: (b)(4).
Event or Problem Description
The following additional information was received through follow-up.Per report, the pupil of the right eye (od) was "peaked" on postoperative day one (1), and resolved three (3) weeks later without treatment.Reportedly, the pupil has normalized and the patient is asymptomatic.The report noted that the surgeon believes it was a steroid response with no further issues anticipated.

• 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: 20364201
• Report Number: 2032546-2024-00114
• Device Sequence Number: 11698861
• Product Code: KYF
• UDI-Device Identifier: 00853704002470
• UDI-Public: 01008537040024701032194317260630213
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K220032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/22/2024

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: 06/30/2026
• Device Model Number: IS3-AU
• Device Lot Number: 321943
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• 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: 62 YR
• Patient Sex: Male
• Patient Race: White