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

Model Number	GTS100L
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device remains in the patient; 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.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Per manufacturing procedure, each device undergoes visual inspection prior to distribution.Based on the results of the investigation, the source of the reported foreign body cannot be determined.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that one (1) day following uneventful cataract plus trabecular micro bypass stent procedure, the surgeon observed a small foreign body on the iris.No intraocular irritation or inflammation observed.The patient was reported as ¿doing well¿ with the stent in ¿perfect position¿.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Through follow-up, the surgeon provided the following update.Reportedly, the stent appeared well positioned postoperatively.Per the surgeon, it is unclear if the foreign body (fb) observed was a metallic fb on the iris as it was "hardly" visible.The prognosis was reported as ¿good¿ without adverse event.

• 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: 8034370
• Report Number: 2032546-2018-00118
• Device Sequence Number: 16469415
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 0100853704002012
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P080030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: GTS100L
• Device Catalogue Number: GTS100L
• Device Lot Number: 116507
• 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: 10/17/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005