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

Model Number	GTS100L
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
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.A malposition stent is 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.The root cause was due to patient movement during implantation attempt.(b)(4).
Event or Problem Description
The surgeon reported that a trabecular micro bypass stent was unable to be implanted due to compromised visualization during the surgical procedure.A second trabecular micro bypass stent was used.The patient moved during implantation attempt and the surgeon inadvertently released the stent posterior to the implantation site.An attempt to retrieve the stent was made but it became embedded in iris tissue.The surgeon made the decision to leave the stent and the procedure was aborted.Clinical follow-up was requested and on 04/16/2018 the surgeon provided the following additional details: the stent's positioning did not result in any adverse impact to the patient and is being managed by monitoring the patient.The patient's current status and prognosis was described as "progressing well from cataract surgery.Will still need glaucoma medications when recovered from surgery." the istent is in a stable position.

• Brand Name: ISTENT TRABECULAR MICRO-BYPASS
• Common Device Name: NTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• MDR Report Key: 7441151
• Report Number: 2032546-2018-00034
• Device Sequence Number: 16521504
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 00853704002012
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2018

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: GTS100L
• Device Catalogue Number: GTS100L
• Device Lot Number: 112641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR