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

Model Number	GTS100R
Medical Device Problem Code	Invalid Sensing (2293)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	02/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient and is not available for evaluation.The device history records were reviewed for this manufacturing lot and there were no non-conformities found to be related to the reported event.Iop elevation is identified in the device labeling as a known inherent risk of glaucoma stent surgery.(b)(4).Submitted to fda: 3/8/2017.
Event or Problem Description
A patient underwent an uneventful cataract and istent surgery of the right eye on (b)(6) 2017.On (b)(6) 2017 the patient presented with an iop of 42.5 mm hg (mean).Preoperatively the patient was on latanoprost for her primary open angle glaucoma.The patient was placed back on latanoprost and combigan was added twice a day for the increased iop.On (b)(6) 2017 the patient's iop improved to 19 mm hg.The adverse event was reported to have recovered with sequelae as the iop is now below baseline and the patient will continue medications.

• 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
• MDR Report Key: 6388217
• Report Number: 2032546-2017-00015
• Device Sequence Number: 1102162
• Product Code: OGO
• UDI-Device Identifier: 00853704002005
• UDI-Public: 01008537040020051010868317190931
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P080030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2017

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: 09/30/2019
• Device Model Number: GTS100R
• Device Lot Number: 108683
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2017
• Initial Report FDA Received Date: 03/08/2017
• 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: 62 YR