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

Model Number	G2-M-IS
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned device was completed.Initial findings through x-ray review found that the trocar was too far forward relative to the insertion tube.The device had been activated one time and two (2) stents were observed remaining inside the injector.No other non-conformance were found during visual inspection and x-ray review.The device was disassembled and it was discovered that the glued trocar assembly had detached from the glue well which allowed it to move forward.No other non-conformance were found during the visual inspection of the inner components.The device history record review of the manufacturing lot was performed and there were no discrepancies or unusual findings related to the reported issue.Additionally, a retain sample from the same lot (lot # 119578) was evaluated, and no non-conformities were found.The trocar was not overextended relative to the insertion tube, and the injector functioned as intended.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 following a left eye cataract plus trabecular micro bypass stent system procedure, the first stent was believed to come loose from the trabecular meshwork (tm) following an implantation attempt.Reportedly, as the surgeon slowly pulled away the injector, the tm ¿tugged back¿ to the injector as if it was refraining the stent from being release.Additionally, the trocar appeared to be extending further out from the barrel of the injector than expected.Out of caution, the surgeon proceeded with a backup device to implant one (1) stent, and there was no patient injury.Additional information has been requested.
Additional Manufacturer Narrative
Mfr# reference: (b)(4).
Event or Problem Description
Through follow-up, the surgeon provided the following additional information.There was no adverse impact to the patient, and the patient was continuing the glaucoma medication for target iop.

• Brand Name: ISTENT INJECT TRABECULAR MICRO BYPASS SYSTEM
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• MDR Report Key: 8500434
• Report Number: 2032546-2019-00047
• Device Sequence Number: 19532627
• Product Code: OGO
• UDI-Device Identifier: 00853704002203
• UDI-Public: 0100853704002203
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P170043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019
• 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: 11/30/2021
• Device Model Number: G2-M-IS
• Device Lot Number: 119578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005