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

Model Number	GTS100L
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: the device is expected to be returned for evaluation but has not been received at glaukos evaluation center.Therefore, product testing on the actual device could not be performed.The device history record review (including sterilization records) of the manufacturing lot was performed and there were no non-conformities found to be related to the reported event.A complaint history review was completed.The electronic complaint system was searched for the specified lot#.There were no similar issues reported for this lot#.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that prior to a trabecular micro bypass stent procedure, a potential foreign particulate was observed in the sterile wrapping of an unopened device.There was no patient contact or injury reported.
Additional Manufacturer Narrative
The device was returned and an evaluation was completed.A foreign particulate was found in the inner thermoform packaging tray.The foreign object was further analyzed for materials characterization.The foreign particulate measured 10.76 mm in length.The material was identified to be polyethylene terephthalate (pet).The particulate is unlikely to have originated from the inner tray or outer tray because they are made of high impact polystyrene (hips) and medical grade polyethylene terephthalate glycol (petg), respectively.The particulate is most likely to have originated from the tyvek lid because it is made out of high-density polyethylene.This closely matches the material of the particulate, which was identified as pet.No non-conformances related to the form, fit, and function of the inserter were found.This particulate did not affect sterility as the unit was sterilized after tray sealing per manufacturing procedure.The customer¿s reported issue is observed.The particulate was identified as pet, and it most likely originated from a tyvek lid as both materials were similar.However, a root cause of how the particulate was introduced was not conclusively identified.Mfr# reference: (b)(4).

• 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: 11829954
• Report Number: 2032546-2021-00058
• Device Sequence Number: 3663647
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 0100853704002012
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P080030
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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: 11/30/2023
• Device Model Number: GTS100L
• Device Lot Number: 105007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 05/15/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1