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

Model Number	GTS100L
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	07/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An explant date was indicated as the stent was removed from the improper placement and implanted (repositioned) in the trabecular meshwork.The device was not available; therefore, product testing on the actual device could not be performed.The device history record review of the manufacturing lot was performed and there were non-conformities found to be related to the reported event.A review of the device labeling was completed.Elevated iop, decreased/impaired vision and malpositioned stent are identified in the labeling as known inherent risks of trabecular micro-bypass stent/cataract procedure.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Based on the information received, the root cause of the reported impaired vision was related to the iol.Mfr# reference: (b)(4).
Event or Problem Description
Initially, a trabecular micro bypass stent patient reported the following event.Following an uneventful left eye cataract plus stent procedure, the patient presented on post-op day one (1) with elevated iop and the surgeon was unable to visualize the stent.Additional glaucoma medications were prescribed and the iop improved.Reportedly, the patient was informed that the stent was "lost", and a stent was subsequently implanted in the left eye approximately two (2) weeks following the initial implant.The patient also reported blurry vision and "abnormal macula" following the initial operation.Per patient, the macula has an "abnormal curve".Through follow-up, the surgeon provided the following additional information.The procedure was uneventful and the surgeon was uncertain about what contributed to stent malpositioning.Postoperatively, the stent was visualized in angle, but not in the trabecular meshwork (tm).The stent positioning did not result in any adverse impact.Per report, the stent was repositioned at patient request.The surgeon noted that the iop did not require intervention beyond standard postop regimen as it is expected to rise at day one (1) postop for glaucoma patients.Reportedly, unexpected refractive result with complaint of visual disturbances were due to multifocal intraocular lens (iol).The multifocal iol was exchanged to monofocal iol which resolved the visual disturbances.The patient prognosis was reported as ¿doing well with adverse event resolved".

• 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: 9291770
• Report Number: 2032546-2019-00143
• Device Sequence Number: 2104716
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 0100853704002012
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P080030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: GTS100L
• Device Catalogue Number: GTS100L
• Device Lot Number: 110063
• 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: 10/22/2019
• Initial Report FDA Received Date: 11/07/2019
• 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: 65 YR
• Date Report Sent to FDA: 01/01/2005