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

Model Number	GTS100L
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: estimated publication date used.The product is not available for evaluation; therefore testing on the actual 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 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.The ifu notes that the safety and effectiveness of the trabecular micro bypass stent has not been established for implantation of more than two (2) stents in one (1) eye, nor for implantation in patient with primary angle closure glaucoma.Mfr# reference: (b)(4).Please reference 2032546-2019-00102 for reported stent occlusions without intervention and unknown device identifiers.Please reference 2032546-2019-00103 for reported serious injury report.Please reference 2032546-2019-00110 for reported second stent occlusion case with known device identifiers.
Event or Problem Description
The following was reported through a review of an article titled "case series of combined istent implantation and phacoemulsification in eyes with primary angle closure disease: one-year outcomes".Following cataract plus trabecular micro bypass stent procedures, there were occlusion of stents with iris in ten (10 ) eyes, hyphema (7), iris atrophy (2), elevated iop (1), iridodialysis (1), corneal edema (1).The report indicates that all complications were managed conservatively without requiring a second surgery and there was no occurrence of sight-threatening complications.Reportedly, among the ten (10) eyes with reported stent occlusion, eight (8) eyes had a single stent implanted, and two (2) eyes had two (2) stents implanted.The report notes that the occlusion occurred in seven (7) eyes within the first 2 months after the surgery and glaucoma medications were subsequently required in three (3) of the ten (10) eyes.In addition, five (5) of the eight (8) eyes with a single stent in situ was fully occluded with iris and the remaining five (5) eyes presented with partially occluded stents.Through follow up device identifiers were provided for 2 of the reported stent occlusion events.This report references the first stent occlusion event.

• 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: 8870403
• Report Number: 2032546-2019-00109
• Device Sequence Number: 16269117
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 0100853704002012
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• PMA/510(K) Number: P080030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2019
• 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: 01/31/2018
• Device Model Number: GTS100L
• Device Catalogue Number: GTS100L
• Device Lot Number: 104645
• Was Device Available for Evaluation?: No
• 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: 07/16/2019
• Initial Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005