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); Visual Impairment (2138)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: (other: hispanic), (b)(4).The device was not available; 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, intraocular inflammation, decreased/impaired vision and iop increase are identified in the labeling as a known inherent risks 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 the information received does not suggest a problem with the device or the way it was used.Based on the information received, the root cause of the reported event is unknown.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that following a left eye cataract plus trabecular micro bypass stent system procedure, the patient presented with post-operative hyphema.The surgeon conferred with the medical monitor to discuss potential treatment options.Through consultation with the medical monitor it was reported that iop was elevated with a clot present inferiorly.The patient was prescribed medication (diamox).Through follow-up, the surgeon reported that the cataract plus stent procedure was uneventful with slight bleeding around the stent.The patient presented post operatively with 40% hyphema.The hyphema was characterized as grade ii (1/3-1/2 anterior chamber volume) and associated with elevated iop and inflammation described as "few cells in anterior chamber (ac)." the patient was started with additional medication (combigan) and evacuation of the hyphema was performed nine (9) days postoperatively.It was reported that the clot is clearing but with slight attachment to the stent.The patient's status was reported as "vision impaired with good prognosis.".
Additional Manufacturer Narrative
Additional information: b5, b6, g3.Mfr# reference: (b)(4).
Event or Problem Description
Through follow-up, the following additional information was received.The patient¿s most current prognosis was reported as ¿good with hyphema cleared and the adverse event resolved¿.

• 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: 9703219
• Report Number: 2032546-2020-00016
• Device Sequence Number: 1742584
• Product Code: OGO
• UDI-Device Identifier: 00853704002203
• UDI-Public: 0100853704002203
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P170043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020
• 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: 126756
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/19/2020
• 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: Required Intervention
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005