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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The stent was not implanted in the proper location, but remains 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 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 was due to surgical technique/experience with the use of the device.Mfr#: (b)(4).
Event or Problem Description
It was reported that following a left eye cataract surgery, the surgeon was unable to implant one (1) of the two (2) stents from a trabecular micro bypass stent system.One (1) stent was implanted deep in the ciliary body, and the surgeon was unable to remove it intraoperatively.A back-up device was used to implant two (2) additional stents.Per report, surgical technique/experience with device contributed to the reported event.Additional information has been requested.
Event or Problem Description
Through follow-up, the surgeon provide the following additional information.The patient underwent an uneventful cataract surgery followed by stent implantation.Per report, the patient was moving significantly during attempt to implant the stent, causing the first stent to be inadvertently placed in the ciliary body instead of trabecular meshwork (tm).An attempt to remove the stent intraoperatively using forceps was made, but the stent was inadvertently pushed further into the tissue and could not be visualized intraoperatively.Postoperatively, the stent was viewed in the ciliary body and there was no adverse impact as a result of stent malpositioning.The patient¿s most recent status was reported as ¿improved vision, limited by history of congenital nystagmus with the iop doing well in both eyes¿.The patient is being monitored without further complications and the adverse event resolved.
Additional Manufacturer Narrative
Correction: the device history record review of the manufacturing lot was performed and there were no non-conformities found to be related to the reported event.Mfr# reference: 29304.

• 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: 10550175
• Report Number: 2032546-2020-00064
• Device Sequence Number: 3546307
• Product Code: OGO
• UDI-Device Identifier: 00853704002203
• UDI-Public: 0100853704002203
• Combination Product (Y/N): Y
• Initial Reporter State: MT
• 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): 10/19/2020

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: 11/30/2022
• Device Model Number: G2-M-IS
• Device Lot Number: 128122
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR