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

Model Number	G2-W-US
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: a6: patient noted as malay.B6, b7: mean and mode used.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.Stent obstruction 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.The reported events (stent obstruction and peripheral anterior synechiae) are established risks 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 2032546-2024-00097 for the reported events associated with the gts100l device.Please reference report 2032546-2024-00105 for the reported events associated with the g2-m-is device.
Event or Problem Description
The following was initially reported through a review of the article titled, "one-year comparative analysis between standalone istent implantation versus combined istent implantation with phacoemulsification." reportedly following trabecular microbypass stent procedures in a total of forty-eight (48) eyes, two (2) operative eyes presented during a postoperative examination with stent occlusion with iris tissue.Per report, none of the patients required a secondary glaucoma procedure.Through follow-up, the following additional information was received.Per report, approximately one (1) year postop following a bilateral procedure (ou), both stent lumen were occluded by peripheral anterior synechiae (pas).Reportedly, the patient is currently on four (4) glaucoma medications (ou).The report noted that both eyes were "phakic", and the surgeon believes "floppy iris" may have contributed to the event.Please see attached article for further details.Reference doi:10.1177/11206721241273678.This report references the report of stent obstruction and peripheral anterior synechiae associated with the g2-w device in the right eye (od).

• Brand Name: ISTENT INJECT W TRABECULAR MICRO BYPASS SYSTEM
• 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: 20242008
• Report Number: 2032546-2024-00104
• Device Sequence Number: 18183451
• Product Code: OGO
• UDI-Device Identifier: 00853704002319
• UDI-Public: 01008537040023191010357017230930
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: G2-W-US
• Device Lot Number: 103570
• 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: 09/09/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2020
• 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: 66 YR
• Patient Sex: Female