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

Model Number	G2-W-US
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the implantation of the second stent from a trabecular microbypass stent system, the patient moved and a small cyclodialysis cleft was subsequently formed in the operative eye.Per report, the surgeon removed both stents intraoperatively.Subsequently during a postop examination, the surgeon thought he saw "something in the cleft" and is unsure if there may be a stent or trocar fragment remaining in the eye.Additional information has b een requested.
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 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 #.A review of the device labeling was completed.Eye injury 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.A review of the device labeling including the risk analysis was completed.The reported issue (trocar fragmentation) is identified to be an anticipated hazard.The residual risk for each potential harm was found to be within the insignificant risk region.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.An adverse event appears to have occurred, but does not appear to have been a problem with the device or the way it was used.The reported events are established risks associated with use of the device, which is clearly specified in the product''s labeling.Based on the information received, the root cause of the reported event could not be conclusively identified.However, the report noted that patient movement contributed to the event.Mfr# reference: (b)(4).
Additional Manufacturer Narrative
The evaluation of the returned device was completed, and the x-ray revealed that the cam assembly had been activated three (3) times and no stents were found.The trigger button motion was functioning as intended; however the device was unable to actuate all remaining positions.The injector¿s insertion sleeve was found bent, which prevented the insertion sleeve retraction motion.The injector¿s splayed trocar was found broken at the splay.The broken tip of the trocar was not returned.These findings likely occurred due to the way the device was shipped back; however, the broken trocar could have occurred during the procedure as described in the customer''s reported event.The device was disassembled and visually inspected.The insertion sleeve assembly and singulator holder were immobile due to the bent frontal components.Further inspection of the insertion tube, singulator, and trocar identified surface features of the trocar indicating a tensile failure.No other non-conformances related to the reported event were found.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 manufacturing internal 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 manufacturing internal procedure.If any of the frontal components were bent during x-ray, the unit should get rejected.Conclusions based on the evaluation findings were confounded by the condition of the returned product.As a result, it was confirmed that the trocar was broken, however a root cause was not definitively identified.Mfr# reference: (b)(4).

• Brand Name: ISTENT INJECT W TRABECULAR MICRO BYPASS SYSTEM
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• Manufacturer (Section G): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: brittany massey ; 229 avenida fabricante; san clemente, CA 92672 ; 949367960
• MDR Report Key: 18097495
• Report Number: 2032546-2023-00122
• Device Sequence Number: 8051473
• Product Code: OGO
• UDI-Device Identifier: 00853704002319
• UDI-Public: 0100853704002319
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P170043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: G2-W-US
• Device Lot Number: 313311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown