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	Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: 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.Malpositioned stent 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.Malpositioned stent 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 surgical technique contributed to the mispositioned stent.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that the surgeon inadvertently mispositioned the first stent (of two stents) from a trabecular microbypass stent system, and subsequently was unable to visualize the stent during attempt to retrieve the mispositioned stent.Per report, a back-up device was used to complete the procedure.The report noted that surgical technique contributed to the event.Additional information has been requested.
Additional Manufacturer Narrative
Of note: the additional information received through follow-up 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 clarification received, 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.Reportedly, the stent was lost outside of the operative eye, and there was no patient injury.

• 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: 19361300
• Report Number: 2032546-2024-00050
• Device Sequence Number: 17093360
• Product Code: OGO
• UDI-Device Identifier: 00853704002319
• UDI-Public: 0100853704002319
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P170043
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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 Expiration Date: 09/30/2026
• Device Model Number: G2-W-US
• Device Lot Number: 316083
• 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
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2023
• 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 Sex: Unknown