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

Model Number	GTS100R
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to glaukos and the device evaluation was completed following decontamination.The tyvek seal was not removed from the outer thermoform packaging tray and a black foreign material was found within the inner tray during visual inspection of the returned device.No nonconformities were observed during the evaluation of the form, fit, and function of the inserter and stent.The device was sent out for fourier-transform infrared spectroscopy (ftir) analysis.The infrared spectrum obtained from the particle indicates the presence of polystyrene and an ester compound, likely a poly(ethylene terephthalate) polymer.Based on the ftir analysis the black foreign material may have been the result of a burnt portion of the tyvek lid or outer thermoform packaging tray when undergoing tray sealing.The device history records were reviewed for this manufacturing lot and there were no non-conformities found to be related to the reported event.Mfr# reference: (b)(4).
Event or Problem Description
Initially, it was reported that ¿black dots¿ were observed on the packaging a trabecular micro bypass stent prior to patient contact.A back device was used to complete the procedure successfully.

• 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: 8287451
• Report Number: 2032546-2019-00003
• Device Sequence Number: 1685978
• Product Code: OGO
• UDI-Device Identifier: 00853704002005
• UDI-Public: 0100853704002005
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 01/29/2019
• 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 Expiration Date: 06/30/2021
• Device Model Number: GTS100R
• Device Catalogue Number: GTS100R
• Device Lot Number: 116598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• 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: 01/08/2019
• Initial Report FDA Received Date: 01/29/2019
• 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