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

Model Number G2-W

Device Problem Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information: the device was not available; therefore, product testing on the actual device could not be performed.The device identifiers were not provided; therefore, the device history records for this device lot number could not be reviewed.A review of the device labeling was completed.Dislodged stent is 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).

Event Description

It was reported that following a cataract plus trabecular microbypass stent system procedure, the surgeon observed a loose stent postoperatively.Through follow-up, the surgeon conferred with glaukos medical monitor who reported discussing with the implanting surgeon methods and treatment options depending on the stent positioning.Additional information has been requested.

• 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 (Section G): GLAUKOS CORPORATION
• Manufacturer Contact: 229 avenida fabricante; san clemente, CA 92672 ; 949367960
• MDR Report Key: 15068099
• MDR Text Key: 304217534
• Report Number: 2032546-2022-00073
• Device Sequence Number: 1
• Product Code: OGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170043
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G2-W
• Device Catalogue Number: G2-W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other