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

Model Number	GTS100R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyphema (1911); Loss of Vision (2139)
Date of Event	07/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded by the customer 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.Hyphema and decreased visual acuity are identified in the device labeling as known inherent risks of glaucoma stent surgery.(b)(4) submitted to fda: 8/11/2016.
Event or Problem Description
The surgeon initially reported being unable to implant the istent due to compromised visualization.Clinical follow-up was requested and on 7/22/2016 the surgeon provided the following additional event details.The patient presented with persisting hyphema 1 day post operation resulting in decreased visual acuity.The hyphema resolved by the 1 week post-operative exam.The patient's visual acuity improved to 20/40 and was reported to be doing well.Additional follow-up has been requested.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Clinical follow-up was requested and on (b)(6) 2016 the surgeon provided the following additional event details.The hyphema was treated with medication and was reported to have resolved with no sequelae.The patient was not taking any anti-coagulant medications pre-operatively or post-operatively.

• Brand Name: ISTENT TRABECULAR MICRO-BYPASS
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): GLAUKOS CORPORATION; 26051 merit circle, suite 103; laguna hills CA 92653
• MDR Report Key: 5869761
• Report Number: 2032546-2016-00050
• Device Sequence Number: 597374
• Product Code: OGO
• UDI-Device Identifier: 00853704002005
• UDI-Public: 01008537040020051010696317190228
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P080030
• 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,Followup
• Report Date (Section B): 07/07/2016

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: 02/28/2019
• Device Model Number: GTS100R
• Device Lot Number: 106963
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2016
• Supplement Report FDA Received Date: 10/18/2016
• 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
• Patient Age: 65 YR