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

Model Number G2-W-JP

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that following a left eye (os) trabecular microbypass stent procedure, the surgeon observed that one (1) of the two (2) stents was strayed into the superior choroidal space.Postoperatively, there were no complications and the intraocular pressure improved (iop decreased).The dislodged stent remains in the patient eye, viewed in the suprachoroidal via computed tomography (ct).Additional information has been requested.

Manufacturer Narrative

Additional information: the device was not available; 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 review of the device labeling was completed.Dislodged 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.Based on the information received, the root cause of the reported event could not be conclusively identified.Mfr# reference: (b)(4).

Manufacturer Narrative

Additional information: b5, b6, g3, g4.Based on the information received, the root cause of the reported event was due to patient''s condition.Mfr# reference: (b)(4).

Event Description

Through follow-up, the surgeon reiterated that computed tomography (ct) scans identified two (2) stents, and reported that the intraocular pressure (iop) decreased with no postoperative complications or any adverse patient impact.The report noted patient anatomy precluded implantation.The patient''s most recent status was described as "no hyphema or iop increase" and the patient is continuing to be monitored.

• Brand Name: ISTENT INJECT W TRABECULAR MICRO BYPASS SYSTEM
• Type of Device: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: 229 avenida fabricante; san clemente, CA 92672 ; 949367960
• MDR Report Key: 15294635
• MDR Text Key: 305587023
• Report Number: 2032546-2022-00094
• Device Sequence Number: 1
• Product Code: OGO
• UDI-Device Identifier: 00853704002340
• UDI-Public: 0100853704002340
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P170043
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G2-W-JP
• Device Lot Number: 303239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male