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

Model Number	GTS100R
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hyphema (1911); Intraocular Pressure Increased (1937); Loss of Vision (2139)
Date of Event	09/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was lost 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 believed to be related to the reported event.Hyphema, iop elevation, decreased vision, and inflammation are identified in the device labeling as known inherent risks of glaucoma stent surgery.(b)(4).Submitted to fda: 11/11/2016.
Event or Problem Description
The surgeon initially reported being unable to implant the istent due to patient anatomy that precluded implantation.Clinical follow-up was requested and on (b)(6) 2016 the surgeon provided the following additional event details.Implantation was not successful due to compromised visualization.During surgery, the istent was lost.The surgeon thoroughly performed i and a and was unable to visualize the istent with postoperative imaging.At the one month post-operation exam the patient complained of irritation likely due to iop lowering drops.The patients vision was reported to have improved and the iop had returned to baseline.The surgeon provided the following additional information to glaukos on 10/31/2016.The surgeon reported that they felt confident that the istent was successfully removed via i and a.The patient presented post-operatively with hyphema resulting in elevated iop.At the time of iop rise the patient was on more glaucoma medications compared to pre-operation.Due to the iop increase, the surgeon reported corneal edema, bcva loss greater than 2 lines compared to preoperative bcva (though both improved by the 1 week post-operative exam).The inflammation was treated with steroids, muro, artificial tears and cold compresses.The patient's iop is currently under control and their visual acuity has improved.The patient continues to complain of irritation.The adverse event was reported to have resolved with sequelae as the iop improved but the cornea still has diffuse pigment on endothelium.

• 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: 6097139
• Report Number: 2032546-2016-00069
• Device Sequence Number: 11046761
• Product Code: OGO
• UDI-Device Identifier: 00853704002005
• UDI-Public: 01008537040020051010649317181130
• 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
• Report Date (Section B): 09/12/2016

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: 11/30/2018
• Device Model Number: GTS100R
• Device Lot Number: 106493
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2016
• Initial Report FDA Received Date: 11/11/2016
• 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: Required Intervention
• Patient Age: 83 YR