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

Model Number	GTS100L
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received by glaukos and the evaluation was completed.No non conformances were found during visual inspection or functional testing of the returned inserter.However, residue was noted on the inserter sleeve and in the inserter tines.The residue had the consistency of dried viscoelastic.Further inspection of all the returned materials could not locate the stent or the reported particulate.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.Based on the results of the investigation, the source of the reported particulate cannot be determined.
Event or Problem Description
It was reported during a left eye cataract plus trabecular micro bypass stent procedure, the surgeon observed a particulate described as a ¿small white fragment¿.Per report, the particulate appeared to come from the lumen of the stent, observed after implantation.The surgeon managed to remove part of the particulate, but some particulate remained on the stent.Subsequently, the surgeon removed the stent from the patient¿s eye intraoperatively.A back-up device was used to complete the procedure successfully.Additional information has been requested.

• Brand Name: ISTENT TRABECULAR MICRO-BYPASS
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• MDR Report Key: 9555146
• Report Number: 2032546-2020-00001
• Device Sequence Number: 2132768
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 0100853704002012
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P080030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2020
• 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: 12/31/2020
• Device Model Number: GTS100L
• Device Catalogue Number: GTS100L
• Device Lot Number: 114113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 01/06/2020
• 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
• Date Report Sent to FDA: 01/01/2005