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

Model Number	GTS1000R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Hyphema (1911)
Date of Event	05/23/2017
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.Iris damage is identified in the device labeling as a known inherent risk of glaucoma stent surgery.Mfr reference # (b)(4).
Event or Problem Description
The surgeon reported that during an istent procedure, there was too much patient movement.This resulted in the iris being torn away from the angle.The tear was approximately two to three clock hours.The istent procedure was aborted and the iris was sutured back in place.Additional information has been requested from the surgeon.
Additional Manufacturer Narrative
Hyphema 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 07/14/2017 the surgeon reported the following additional event details.The patient flinched during placement of the stent causing the stent to tear the iris from the iris root.At the time of the incident, six sutures were required to secure the iris root and repair the iridodialysis.Postoperative bleeding was characterized as persistent hyphema greater than 2mm after one day.The surgeon reported that the event did not result in any loss of best corrected visual acuity and there has been no adverse impact to the patient to date.The patient is currently doing well with hyphema resolved and intraocular pressure (iop) stabilized within the 10-20 mm hg range.The surgeon will continue to monitor the patient for any changes.

• 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: 6638923
• Report Number: 2032546-2017-00047
• Device Sequence Number: 86774
• Product Code: OGO
• UDI-Device Identifier: 00853704002005
• UDI-Public: 00853704002005
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/14/2017

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: GTS1000R
• Device Lot Number: 109710
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 07/14/2017
• 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: 79 YR