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

Model Number	GTS100R
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient and is not available for evaluation.The device history records were reviewed for this manufacturing lot and there were no non-conformities found to be related to the reported event.Any omitted information was not available at the time of initial report.Stent obstruction is identified in the device labeling as a known inherent risk of glaucoma stent surgery.(b)(4).
Event or Problem Description
The surgeon reported that a clinical trial patient presented approximately 12 weeks postoperatively with stent obstruction.The obstruction was treated with yag laser.The patient is reportedly 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: 6884803
• Report Number: 2032546-2017-00080
• Device Sequence Number: 505636
• Product Code: OGO
• UDI-Device Identifier: 00853704002005
• UDI-Public: 00853704002005
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: GTS100R
• Device Catalogue Number: GTS100R
• Device Lot Number: 108830
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR