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	Eye Injury (1845)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not available; therefore, product testing on the actual device could not be performed.The device history records were reviewed for this manufacturing lot and there were no non-conformities found to be related to the reported event.A review of the device labeling was completed.Iris damage is identified in the labeling as a known inherent risk of trabecular micro-bypass stent surgery.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Based on the results of the investigation, a quality product deficiency was not identified.The root cause of the reported could not be conclusively determined.(b)(4).
Event or Problem Description
It was reported that during a right eye cataract plus trabecular micro-bypass stent procedure, the inserter engaged the iris when the stent was re-grasped by the surgeon.Per report, the visibility was compromised due to heme.An iridodialysis was observed intraoperatively and the iris extruded the wound.The surgeon attempted to place the iris back in the anterior chamber and sutures were required.The stent was removed from the eye and the procedure was aborted.Additional information has been requested.
Event or Problem Description
Through follow-up, the surgeon provided the following the additional information.At one (1) month post-op examination, the patient presented with "a 2+ capsule fibrosis, with peripheral fibrosis acting as pseudo iris".The iris damage was characterized as permanent and a "total dialysis from 11:00 to 5:00".A yag procedure was performed, and the patient was reported as ¿happy¿ with improved visual acuity following correction.The patient remains on steroids, and will need a yag if the peripheral fibrosis continues.The surgeon plans to recheck the iop when the patient is off steroids.
Additional Manufacturer Narrative
Mfr# reference: (b)(4).

• 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: 7895742
• Report Number: 2032546-2018-00092
• Device Sequence Number: 1758471
• Product Code: OGO
• UDI-Device Identifier: 00853704002005
• UDI-Public: 0100853704002005
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 10/19/2018
• Report Date (Section F): 01/01/2005

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: 05/31/2021
• Device Model Number: GTS100R
• Device Catalogue Number: GTS100R
• Device Lot Number: 116085
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 10/19/2018
• 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: 64 YR
• Date Report Sent to FDA: 01/01/2005