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

Model Number	G2-M-IS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyphema (1911); Intraocular Pressure Increased (1937); Visual Impairment (2138)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: estimated based on the information received.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 non-conformities found to be related to the reported event.A review of the device labeling was completed.Hyphema, elevated iop and vitreous hemorrhage are identified in the labeling as known inherent risks of trabecular micro-bypass stent/cataract procedure.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Based on the information received, the root cause of the reported event was likely due to patient post-op activity.
Event or Problem Description
It was reported that following a right eye cataract plus trabecular micro bypass stent system, the patient presented with post-operative hyphema.Through follow-up, the surgeon reported that the procedure was uneventful.The reported hyphema was characterized graded as grade i (less than or equal to 1/3 of the anterior chamber volume) which was associated with iop increase and decreased vision.The patient was treated with steroids and glaucoma drops for one (1) week.The most recent status was reported as ¿resolved and drops will be discontinued¿.Reportedly, the patient was not on any anticoagulants.According to the surgeon, the patient¿s movement with daily activities (postoperative) likely contributed to the reported event.

• Brand Name: STENT INJECT TRABECULAR MICRO BYPASS SYSTEM
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• MDR Report Key: 9592708
• Report Number: 2032546-2020-00010
• Device Sequence Number: 10899242
• Product Code: OGO
• UDI-Device Identifier: 00853704002203
• UDI-Public: 0100853704002203
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P170043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2020
• Report Date (Section F): 01/01/2005

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: 09/30/2022
• Device Model Number: G2-M-IS
• Device Lot Number: 126567
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005