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

Model Number	GTS100R
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant date: the stent was unable to be implanted in the proper location, but remains in the patient¿s eye therefore the surgery date was indicated in the implant field.The device remains in the patient¿s left eye; therefore, product testing on this 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.In addition, a complaint history review was completed for lot 110944 and no similar issues have been reported.A review of the device labeling was completed.Stent malposition is identified in the labeling as a known inherent risk of glaucoma stent surgery.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.There are numerous factors that may contribute to a stent being implanted in an unintended location including but not limited to; patient anatomy, patient movement, surgical technique, compromised visualization and operational context.The omitted information was requested, but was not provided.Mfr reference # (b)(4).
Event or Problem Description
The surgeon reported that during a trabecular micro-bypass stent procedure on the left eye, the stent was lost in the ciliary body band.The surgeon attempted to retrieve the stent; however, it was pushed in further and could not be retrieved.A backup stent was successfully implanted.There was no adverse impact to the patient.Clinical follow-up was requested and on (b)(6) 2018 the surgeon provided the following additional details.The stent could not be visualized in the ciliary body during postoperative imaging.The backup stent that was placed is well-positioned in schlemm¿s canal.There has been no adverse impact to the patient who will be monitored.The patient¿s current status and prognosis is ¿excellent¿ and the event has 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: 7173705
• Report Number: 2032546-2018-00001
• Device Sequence Number: 13666544
• Product Code: OGO
• UDI-Device Identifier: 00853704002005
• UDI-Public: 00853704002005
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2018

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: 04/30/2020
• Device Model Number: GTS100R
• Device Catalogue Number: GTS100R
• Device Lot Number: 110944
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR