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

Model Number	G2-M-IS
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Eye Injury (1845); Foreign Body In Patient (2687)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent could not be located and suspected to remain in the patient's eye; therefore, the surgery date was indicated in the implant date field.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 and malpositioned stent are identified in the labeling as known inherent risks of trabecular micro-bypass stent procedure.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Mfr # reference: (b)(4).
Event or Problem Description
It was reported that following a right eye cataract procedure, the patient moved during implantation attempt of a trabecular micro bypass stent system.Due to patient movement, the insertion sleeve engaged the iris which resulted in a small iris tear.The surgeon¿s vision was obscured due to intraoperative heme and could not locate the stent.Reportedly, it is possible that the stent was removed during irrigation/aspiration (ia).The stent procedure was aborted.Additional information has been requested.
Additional Manufacturer Narrative
Mfr# reference: (b)(4).
Event or Problem Description
Reportedly, the stent procedure was aborted due to poor visualization (intraoperative bleed) as a result of iris trauma secondary to patient movement during surgery.The surgeon characterized the iris damage as a two o¿clock (2.00) trivial/inconsequential damage requiring no intervention.The patient prognosis was reported as ¿good with adverse event resolved¿.

• Brand Name: ISTENT INJECT TRABECULAR MICRO BYPASS SYSTEM
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente 92672
• MDR Report Key: 8647448
• Report Number: 2032546-2019-00075
• Device Sequence Number: 1748312
• Product Code: OGO
• UDI-Device Identifier: 00853704002203
• UDI-Public: 0100853704002203
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P170043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: G2-M-IS
• Device Lot Number: 120669
• 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: 05/07/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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: 69 YR
• Date Report Sent to FDA: 01/01/2005