MAUDE Adverse Event Report: GLAUKOS CORPORATION ISTENT TRABECULAR MICRO BYPASS; INTRAOCULAR PRESSURE LOWERING IMPLANT

Model Number	G2-M-IS-US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyphema (1911)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: b6, b7: mean and mode used.B3: aware date used for date of event.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 was completed.Hyphema 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.Hyphema 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).Please reference report 2032546-2023-00121 for the case of macular edema in patient two (2) of two (2).
Event or Problem Description
The following was reported through a review of the article titled "comparing outcomes of phacoemulsification and endocyclophotocoagulation with either dual blade goniotomy (peck) or two trabecular stents (ice2)." reported, following cataract plus trabecular microbypass stent procedures in a total of forty-two (42) patients, one (1) patient presented postop with a persistent hyphema beyond three (3) months in the left operative eye (os), and one (1) patient presented with cystoid macular edema (cme) in the right operative eye (od).Through follow-up, the following additional information was received.Per report, there was no medical or surgical intervention required to treat the case of hyphema, which resolved by postop month six (6).Per report, the case of cystoid macular edema (cme) was "more likely" associated with the phacoemulsification and endoscopic cyclophotocoagulation (ecp) procedure, however the stent may have contributed.Reportedly, the patient was referred to a retina specialist, and treated with medication with the (cme) resolved by postop year one (1).Any omitted information was not provided through follow-up.Please see the attached article for further details.Reference doi: 10.2147/opth.S431356.This report references the case of hyphema in patient one (1) of two (2).

• Brand Name: ISTENT TRABECULAR MICRO BYPASS
• 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: 18041154
• Report Number: 2032546-2023-00120
• Device Sequence Number: 20852555
• Product Code: OGO
• UDI-Device Identifier: 00853704002203
• UDI-Public: 0100853704002203
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P170043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2023

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: 05/31/2022
• Device Model Number: G2-M-IS-US
• Device Lot Number: 124202
• 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: Not provided
• Initial Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• 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: 67 YR
• Patient Sex: Female