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	09/05/2018
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 right eye cataract procedure, the patient moved his head during a trabecular micro-bypass stent procedure which resulted in approximately 3 clock hours of iridodialysis superonasally.The stent was successfully removed from the patient¿s eye, and the procedure was aborted.Reportedly, the patient may need iridoplasty in the future.Additional information has been requested.
Additional Manufacturer Narrative
The device was received by glaukos and the evaluation was completed.Evaluation of the returned device found no non conformances during visual inspection and functional testing of the inserter.Based on the results of the investigation, no quality product deficiency was identified.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 92672
• MDR Report Key: 7914763
• Report Number: 2032546-2018-00095
• Device Sequence Number: 13645691
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 0100853704002012
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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): 11/15/2018
• 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: 116144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 11/15/2018
• 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: 71 YR
• Date Report Sent to FDA: 01/01/2005