MAUDE Adverse Event Report: GLAUKOS CORPORATION ISTENT INFINITE TRABECULAR MICRO-BYPASS SYSTEM; AQUEOUS SHUNT

Model Number IS3-US

Device Problem Malposition of Device (2616)

Patient Problems Corneal Edema (1791); Foreign Body In Patient (2687)

Event Date 09/01/2023

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.Corneal edema and malpositioned 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.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.Each reported event is an established risk associated with use of the device, which is clearly specified in the products' labeling.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 patient presented postoperatively with the stent visible in the cornea, sitting securely without perforating the cornea.Through follow-up, the surgeon consulted with expert opinion md who reported discussing that the stent may actually be in the peripheral cornea without concern.Discussion also included a report of patients corneal edema and subsequent treatment options based on the patients' condition.Additional information has been requested.

• Brand Name: ISTENT INFINITE TRABECULAR MICRO-BYPASS SYSTEM
• Type of Device: AQUEOUS SHUNT
• 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: 17785856
• MDR Text Key: 323904880
• Report Number: 2032546-2023-00102
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS3-US
• 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