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

Model Number	GTS100L
Medical Device Problem Codes	Use of Device Problem (1670); Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device remains in the patient, therefore product testing on the devices 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.A review of the device labeling was completed.Malpositioned stent is identified in the labeling as a known inherent risks of intraocular surgery.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.(b)(4).
Event or Problem Description
It was reported that the surgeon inadvertently placed the stent in the ciliary body band.Several attempts were made to retrieve the stent but eventually the surgeon decided to leave it where it was to prevent possible damage in attempts at retrieving it.The stent was visible at the end of the case.A backup stent was not implanted.Additional information has been requested.

• Brand Name: ISTENT TRABECULAR MICRO-BYPASS
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLAN
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente; CA 92672
• MDR Report Key: 7463381
• Report Number: 2032546-2018-00035
• Device Sequence Number: 13726406
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 00853704002012
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 04/24/2018

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: 11/30/2020
• Device Model Number: GTS100L
• Device Catalogue Number: GTS100L
• Device Lot Number: 113809
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR