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

Model Number	GTS100L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	09/18/2018
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 event was due to patient movement during procedure.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that following a left eye cataract surgery, the patient continuous ¿abrupt¿ head movement during attempted implantation of a trabecular micro-bypass stent caused the surgeon to inadvertently create an iridotomy with the stent.The stent was removed from the patient¿s eye and the procedure was aborted.Additional information is being requested.
Additional Manufacturer Narrative
Mfr# reference: (b)(4).
Event or Problem Description
Through follow-up, the surgeon provided the following additional information.The iris damage was characterized as inconsequential (trivial), which did not require any medical or surgical interventions.The iris damage was observed approximately 9 o¿clock (small area of iris loss).According to the surgeon, the patient attempted to sit up during implantation attempt which contributed to the reported event.The prognosis was reported as ¿eye is well healed¿ after surgery.

• 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: 7957119
• Report Number: 2032546-2018-00099
• Device Sequence Number: 1514051
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 0100853704002012
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 11/16/2018
• 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: GTS100L
• Device Catalogue Number: GTS100L
• Device Lot Number: 115769
• 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: 09/18/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/16/2018
• 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: Other
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005