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

Model Number	G2-M-IS-US
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device remains in the patient's eye, thus, date of implant is indicated.The device has been return to glaukos for evaluation, and the investigation is ongoing.The device history record review of the manufacturing lot was performed, and there were no non-conformities found to be related to the reported event.A review of the device labeling was completed.Malpositioned stent is identified in the labeling as a known inherent risk of trabecular micro-bypass stent procedure.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 during a cataract plus trabecular micro bypass stent system procedure, the surgeon implanted one (1) of the two (2) stents in an ¿incorrect spot¿.The stent procedure was aborted with no report of patient¿s injury.Per report, surgical technique and experience with the device contributed to the reported event.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: evaluation of the returned device was completed.The x-ray evaluation revealed that the cam assembly was activated four (4) times and no stents were found.The trigger button motion was functioning as intended.The injector¿s frontal components were found to be bent.This finding may have occurred due to the condition in which the device was shipped back for evaluation.It is highly unlikely that the device was sent out in this condition as the frontal components undergo critical dimension inspection after injector assembly per the manufacturing procedure.If any of the frontal components were bent, the device should fail inspection and the unit should get rejected.Furthermore, all devices undergo visual inspection via x-ray per the manufacturing procedure.If any of the frontal components were bent during x-ray, the unit should get rejected.There was no non-conformance related to the reported event.The root cause of the reported issue could not be conclusively determined due to the condition of the returned device.Mfr# reference: 29932.

• 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: 10865257
• Report Number: 2032546-2020-00093
• Device Sequence Number: 19573931
• Product Code: OGO
• UDI-Device Identifier: 00853704002203
• UDI-Public: 0100853704002203
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P170043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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: 09/30/2022
• Device Model Number: G2-M-IS-US
• Device Lot Number: 127065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR