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 Code	Iritis (1940)
Date of Event	02/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not available for return.The device history records were reviewed for this manufacturing lot and there were no non-conformities found to be related to the reported event.Iritis is identified in the device labeling as a known inherent risk of glaucoma stent surgery.(b)(4).Submitted to fda on 03/24/2017.
Event or Problem Description
The surgeon initially reported that after several attempts they could not successfully implant the istent, and the procedure was aborted.Clinical follow-up was requested, and on (b)(6) 2017, the surgeon provided the following initial event details.The surgeon was unable to implant the istent due to compromised/obscured visualization.There was transient intraoperative bleeding that was self-resolving.During the patient¿s one week postoperative visit, 2+ cell and flare was noted in the anterior chamber.Prognosis was reported to be good.Clinical follow-up was requested, and on (b)(6) 2017 the surgeon providing the following event details.The patient presented with postoperative iritis requiring prednisolone acetate and prolensa topically.The adverse event was reported to be ongoing/persistent, although the patient was reported to be substantially improved and is scheduled to have a recheck on (b)(6) 2017.Additional information will be requested.
Additional Manufacturer Narrative
Mfr reference #(b)(4).Submitted to fda on 04/19/2017.
Event or Problem Description
Clinical follow-up was requested and on 04/17/2017 the surgeon provided the following additional event details.No additional intervention has been taken.The event has 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: 6434040
• Report Number: 2032546-2017-00020
• Device Sequence Number: 943187
• Product Code: OGO
• UDI-Device Identifier: 00853704002005
• UDI-Public: 01008537040020051010926617191231
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2017

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: 12/31/2019
• Device Model Number: GTS100R
• Device Lot Number: 109266
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 04/19/2017
• 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: 67 YR