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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Hyphema (1911)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: the stent was scheduled for explantation, therefore, the planned explantation date was indicated in the explant date field.The device was not available; therefore, product testing on the actual device could not be performed.The device history records were reviewed for this manufacturing lot and there were no non-conformities found to be related to the reported event.A review of the device labeling was completed.Hyphema and dislodged stent are identified in the labeling as known inherent risks 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 following a left eye cataract plus trabecular micro bypass stent system procedure, the patient presented on post-op week two (2) with hyphema.On post-op day one (1) the stent was seated properly; however, a ¿white sticky substance¿ was observed in the hyphema and pulled one (1) of the stents out from the trabecular meshwork (tm).The surgeon planned to remove the floating stent from the patient's left eye.Additional information has been requested.
Additional Manufacturer Narrative
Mfr ref # (b)(4).H3 other text : placeholder.
Event or Problem Description
Through follow up the additional information was provided.Postoperatively, the stent could not be visualized due to hyphema clot.The hyphema was characterized as grade ii (1/3-1/2 anterior chamber vol.) which required an anterior chamber washout.The dislodged stent was explanted and replaced with a new stent.The stent positioning did not result in any adverse impact to the patient.The patient was reported as ¿stable, good prognosis with resolved adverse event¿.

• 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: 8501941
• Report Number: 2032546-2019-00049
• Device Sequence Number: 11452913
• Product Code: OGO
• UDI-Device Identifier: 00853704002203
• UDI-Public: 01008537040022031
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P170043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: G2-M-IS
• Device Lot Number: 118779
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005