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 Code	Foreign Body In Patient (2687)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device remains in the patient's eye; thus, date of implant is indicated.The device was not available; therefore, product testing on the actual device could not be performed.The device history record review of the manufacturing lot was performed and there were non-conformities found to be related to the reported event.A review of the device labeling was completed.Malpositioned stent is identified in the labeling as a known inherent risk 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.Based on the information received, the root cause of the reported event could not be conclusively identified.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that during a cataract plus trabecular micro bypass stent system procedure, the surgeon inadvertently placed one (1) of the two (2) stents into the patient¿s iris intraoperatively.Through follow-up, the surgeon conferred with glaukos medical monitor who reported that the surgeon planned to leave the stent in place and will continue to monitor the patient.Additional information has been requested.
Additional Manufacturer Narrative
Mfr# reference: 29056.
Event or Problem Description
Through follow-up, the surgeon reported the following additional information.Reportedly, poor visualization as a result of intraoperative transient bleeding contributed to the stent malpositioning in the patient¿s right eye.Per report, the stent could not be visualized postoperatively, and the stent positioning did not result in any adverse event.The patient¿s current status was reported as ¿very advanced glaucoma on both eyes (ou)¿ with adverse 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 CA 92672
• MDR Report Key: 10439937
• Report Number: 2032546-2020-00059
• Device Sequence Number: 2737844
• Product Code: OGO
• UDI-Device Identifier: 00853704002203
• UDI-Public: 0100853704002203
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: G2-M-IS
• Device Lot Number: 122189
• 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: 07/31/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Date Report Sent to FDA: 01/01/2005