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

Model Number	GTS100L
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Uveitis (2122); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: a2, a3, b5, b6, b7: mean and mode used.B3: publication date used for event date.The devices were not available; therefore, product testing on the actual devices could not be performed.The device identifiers were not provided; therefore, the device history records for these device lot numbers could not be reviewed.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.Stent obstruction 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).
Event or Problem Description
The following was 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.Additional information has been requested.Please see attached article for further details.Reference doi:10.1177/11206721241273678.
Event or Problem Description
Through follow-up, the following additional information was received.Per report, the patient has recurrent uveitis (od), characterized as "intermediate" which the surgeon believes may have contributed to the stent obstruction.Reportedly, the patient underwent an unsuccessful laser treatment to the iris tissue and a subsequent trabeculectomy.This report references the case of stent obstruction and uveitis associated with the gts100 device.Please reference the article submitted with the initial report for additional information.
Additional Manufacturer Narrative
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.Uveitis 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.Uveitis 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: 42724 please reference report 2032546-2024-00104 for the reported events associated with the g2-w device.Please reference report 2032546-2024-00105 for the reported events associated with the g2-m-is device.

• 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: 20100535
• Report Number: 2032546-2024-00097
• Device Sequence Number: 12655085
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 01008537040020121011795517210831
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P080030
• 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,Followup
• 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: 08/31/2021
• Device Model Number: GTS100L
• Device Lot Number: 117955
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2018
• 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: 76 YR
• Patient Sex: Male
• Patient Race: Asian