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	Foreign Body In Patient (2687)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The stent was not implanted in the proper location, but may remain in the patient's eye therefore the surgery date was indicated in the implant date field.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.Malpositioned stent 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.Based on the information received, the root cause of the reported event was due to operational context (experience with the device).Mfr# reference: (b)(4).
Event or Problem Description
It was initially reported that during a left eye cataract plus trabecular micro bypass stent procedure, the surgeon was unable to properly implant the stent in the right position (in the trabecular meshwork).Per report, surgical technique and experience with device contributed to the reported event.A back-up device was used to complete the procedure.There was no patient injury and there was no surgical or medical intervention required.Additional information was requested and the surgeon reported that after implantation attempt, the stent could not be located.It is unknown if the device remains in the patient's eye as the surgeon could not locate it.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: 9497111
• Report Number: 2032546-2019-00155
• Device Sequence Number: 209217
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 0100853704002012
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• PMA/510(K) Number: P080030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2019
• 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 Model Number: GTS100L
• Device Catalogue Number: GTS100L
• Device Lot Number: 120951
• 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: 12/02/2019
• Initial Report FDA Received Date: 12/19/2019
• 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