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

Model Number	GTS100R
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2018
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 stent remains in the patient's eye and it is not available for evaluation; therefore product testing on this 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.As part of the device history records review the sterilization records for this lot were reviewed and this device lot passed sterility test.In addition, a complaint history review was completed.There were no complaints identified related to the reportable event.A review of the device labeling was completed.Malpositioned stent is identified in the device labeling as a known inherent risk of trabecular micro-bypass stent surgery.The ifu adequately provides instructions, precautions, and warnings for the proper use and handling of the device.Based on the results of the investigation, quality product deficiency was not identified.The omitted information was requested but was not provided.(b)(4).
Event or Problem Description
The surgeon reported that he was unable to implant a trabecular micro-bypass stent.The stent was lost in the eye during the surgical procedure and was not removed from the patient's eye.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: describe event or problem.The omitted information was requested but was not provided.(b)(4).
Event or Problem Description
Clinical follow-up was requested and on 04/16/2018 the surgeon provided the following additional details; the istent procedure of the right eye was aborted due to patient movement.The patient status and prognosis was reported to be good.

• 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: 7378668
• Report Number: 2032546-2018-00029
• Device Sequence Number: 1446231
• Product Code: OGO
• UDI-Device Identifier: 00853704002005
• UDI-Public: 00853704002005
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 05/08/2018

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: 08/31/2020
• Device Model Number: GTS100R
• Device Catalogue Number: GTS100R
• Device Lot Number: 112966
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 05/09/2018
• 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