MAUDE Adverse Event Report: GLAUKOS CORPORATION ISTENT 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)
Date of Event	04/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age or date of birth: year of birth: (b)(6).The device was not returned, therefore product testing on the actual device could not be performed.The device history records were reviewed for this manufacturing lot and there were no non-conformities found to be related to the reported event.A review of the device labeling was completed.Hyphema, elevated iop 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.Mfr# reference: (b)(4).
Event or Problem Description
It was initially reported that following a left eye cataract procedure, the trabecular micro bypass stent system procedure was aborted due to compromised visibility intraoperatively.Through follow-up, the surgeon reported that the stent procedure was aborted due to iris prolapse during insertion into the eye which caused bleeding.A secondary surgical intervention was performed to remove clot and heme due to elevated iop.Reportedly, patient status appeared to be improving.

• Brand Name: ISTENT 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: 8633741
• Report Number: 2032546-2019-00073
• Device Sequence Number: 2016597
• Product Code: OGO
• UDI-Device Identifier: 00853704002203
• UDI-Public: 0100853704002203
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P170043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2019
• 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: 11/30/2021
• Device Model Number: G2-M-IS
• Device Lot Number: 119873
• 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: 05/03/2019
• Initial Report FDA Received Date: 05/22/2019
• 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: Required Intervention
• Date Report Sent to FDA: 01/01/2005