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	12/03/2019
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.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that during cataract plus trabecular micro bypass stent system procedure, the surgeon inadvertently implanted both stents in the ciliary body, one on top of the other.A back-up device was used to implant two (2) stents successfully.There was no patient injury.Additional information has been requested.
Event or Problem Description
Through follow-up the surgeon provided the following additional information.The patient underwent a right eye cataract plus stent procedure.During postop examination, one (1) stent appeared visible in the ciliary body and the other two stents implanted in the trabecular meshwork (tm).According to the surgeon, lack of pigmentation of the angle structures and mild corneal edema limiting the intraoperative view contributed to the stent malpositioning.The stent positioning will be monitored and there is no report of planned intervention (medical or surgical).Per report, the patient presented on post-op day one (1) with hyphema which resolved within a week without medical or surgical intervention.The patient most recent status was reported as ¿doing well with adverse event resolved¿.
Additional Manufacturer Narrative
Additional information: a1, a2, a3, b5, b6, b7, g3.Correction: e1.Based on the information received, compromised intraoperative visualization by patient anatomy likely contributed to the reported event.Mfr# reference:26170.H3 other text : placeholder.

• 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: 9500572
• Report Number: 2032546-2019-00156
• Device Sequence Number: 19130032
• Product Code: OGO
• UDI-Device Identifier: 00853704002203
• UDI-Public: 0100853704002203
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 01/20/2020
• 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: 08/31/2022
• Device Model Number: G2-M-IS
• Device Lot Number: 126119
• 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: 12/03/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Date Report Sent to FDA: 01/01/2005