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

Model Number	GTS100R
Medical Device Problem Codes	Obstruction of Flow (2423); Malposition of Device (2616)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device remains implanted in the patient, therefore product testing on the 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.A 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 found to be related to the reported event.A review of the device labeling was completed.Iop increase as well as a dislodged stent are identified in the labeling as a known inherent risks of trabecular micro-bypass stent/intraocular surgery.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Reference # (b)(4).
Event or Problem Description
It was reported through a post-market clinical trial that following an uncomplicated cataract surgery and implantation of a trabecular micro-bypass stent a patient presented on postoperative day eight (8) and ¿stent migration¿ was observed.The stent was initially implanted at the 3:00 position.A (b)(6) performed on postoperative day 15 ((b)(6) 2017) showed an artifact that may possibly have been the stent; however, the doctor was unable to confirm via gonioscopy.On postoperative day 26 ((b)(6) 2018), (b)(6) confirmed the presence of the stent at approximately the 2:30 position.The status of the stent is currently ¿unchanged¿ and has not resulted in any adverse impact to the patient.Of note the patient presented 3 hours post-operation with an iop increase greater than or equal to 10mm hg above baseline and was placed back on a iop lowering medication (simbrinza bid).The event was reported to have resolved by post op day one as the patient¿s iop lowering medications were discontinued prior to surgery.
Additional Manufacturer Narrative
A review of the device labeling was completed.Stent obstruction 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
The following additional information was received.The patient presented with stent obstruction postoperative.The stent obstruction was treated with medication and a ubm was performed on (b)(6) 2018.The patient¿s recent status was reported as ¿recovering¿.

• 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: 7301556
• Report Number: 2032546-2018-00021
• Device Sequence Number: 11261246
• Product Code: OGO
• UDI-Device Identifier: 00853704002005
• UDI-Public: 00853704002005
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P080030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2018
• 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: 08/31/2020
• Device Model Number: GTS100R
• Device Catalogue Number: GTS100R
• Device Lot Number: 112709
• 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: 02/01/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 12/10/2018
• 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