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

Model Number	GTS100L
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available; therefore, product testing on the actual 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.Based on the information available, the root cause of the reported event cannot be determine.The decision to report was based on lack of information regarding the location of the stent.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that following a right eye cataract procedure, the surgeon was unable to implant a trabecular micro bypass stent in the operative eye (od).The surgeon subsequently performed goniotomy and there was no patient injury.Per report, the location of the stent could not be confirmed (unknown) after unsuccessful implantation attempt.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: 7970075
• Report Number: 2032546-2018-00104
• Device Sequence Number: 19267405
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 0100853704002012
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P080030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2018
• 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 Expiration Date: 10/31/2020
• Device Model Number: GTS100L
• Device Catalogue Number: GTS100L
• Device Lot Number: 113481
• 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: 09/21/2018
• Initial Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005