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	Eye Injury (1845); Intraocular Pressure, Delayed, Uncontrolled (1936); Loss of Vision (2139)
Date of Event	06/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device 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.Any omitted information was not available at the time of initial report.Written correspondence has been sent to the surgeon requesting the outstanding information.Subsequent attempts will be made as necessary.Cyclodialysis cleft, hypotony, decreased visual acuity, increased iop, and inflammation are identified in the device labeling as known inherent risks of glaucoma stent surgery.(b)(4).
Event or Problem Description
It was initially reported that the stent could not be implanted because the view was obscured by heme, and the procedure was aborted.On (b)(6)2017, the surgeon provided the following additional event details.The surgeon had difficulty implanting the stent, and after regrasping several times, the procedure was aborted.At the time, there was no indication of any adverse effects.Postoperatively, the patient presented with hypotony.The patient¿s intraocular pressure (iop) has ranged from 3-5 mm hg.The surgeon conferred with the glaukos medical monitor on (b)(6)2017 who reported that there is concern that a cyclodialysis cleft may have been created and indicated that a gonioscopy would help to confirm this.The glaukos medical monitor and the surgeon discussed different treatment options including a cycloplegic, steroids, laser or other surgical interventions if the hypotony persists.The surgeon reported that the patient was a week out from surgery with increasing flare and decreased visual acuity from 20/40 to 20/80.The patient was prescribed a cycloplegic, ilevro, and switched from prednisolone acetate to durezol four times per day.On (b)(6)2017, through discussion with the glaukos medical monitor, the surgeon reported that gonioscopy revealed a cleft of approximately three clock hours.The surgeon has discontinued dilation and prednisolone acetate as the patient¿s iop has increased to 30 mm hg.The patient was put back on the preoperative beta blocker once a day.The glaukos medical monitor and the surgeon discussed the patient¿s prognosis as the cleft appears to be closed and is likely responsible for the pressure spike.The pressure is expected to decrease over the next few days.Additional information will be requested.
Additional Manufacturer Narrative
Iris atrophy is identified in the device labeling as a known inherent risk of glaucoma stent surgery.(b)(4).
Event or Problem Description
Clinical follow-up was requested and on 07/25/2017, the surgeon provided the following additional details.The patient presented on postoperative day four (4) with a cyclodialysis cleft approximately three clock hours in size.The cleft was acutely managed with cycloplegia and minimal anti-inflammatory drops.The inflammation was treated with topical prednisolone acetate.The surgeon reported that the primary reason for the intraocular pressure (iop) rise was closure of the cyclodialysis cleft.The patient was prescribed timolol 5% daily for approximately one week to treat the elevated iop.The surgeon reported that the patient had an irregular pupil with atrophic sphincter at 7 to 8 o'clock; however the patient's vision and iop had improved.The inflammation and cyclodialysis cleft were reported as resolved.

• 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: 6675151
• Report Number: 2032546-2017-00053
• Device Sequence Number: 18843097
• Product Code: OGO
• UDI-Device Identifier: 00853704002005
• UDI-Public: 00853704002005
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P080030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2017

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: 01/31/2020
• Device Model Number: GTS100R
• Device Catalogue Number: GTS100R
• Device Lot Number: 109501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 07/28/2017
• 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