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

Model Number	GTS100L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains 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 for this lot, there were no complaints found to be related to the reported event.A review of the device labeling was completed.Inflammation is identified in the labeling as a known inherent risk of intraocular surgery.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Any omitted information was not available at the time of initial report.Written correspondence has been sent to the surgeon requesting the outstanding information.Subsequent attempts will be made as necessary.Mfr reference #(b)(4).
Event or Problem Description
It was reported that an istent patient presented approximately one month post-op with potential iris/snorkel touch.Some cells were observed in the anterior chamber requiring treatment with durezol drops.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: 7463392
• Report Number: 2032546-2018-00036
• Device Sequence Number: 16395712
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 00853704002012
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2020
• Device Model Number: GTS100L
• Device Catalogue Number: GTS100L
• Device Lot Number: 113201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 04/25/2018
• 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: 67 YR