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 Hyphema (1911); Intraocular Pressure Increased (1937); Foreign Body In Patient (2687)

Event Date 11/09/2023

Event Type  Injury  

Manufacturer Narrative

Additional information: the device remains implanted in the patient; 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.Hyphema, iop increase, 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.The reported events (hyphema, iop increase, and malpositioned stent) 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 reported noted that surgical technique/experience with the device contributed to the stent mispositioning.Mfr# reference: (b)(4).

Event Description

It was reported that following an uneventful cataract plus trabecular microbypass stent system procedure, the patient presented on postop day one (1) with elevated intraocular pressure (iop) associated with hyphema characterized as 3+ cell and circulating red blood cells without layering.Per report, a gonioscope examination revealed that one (1) of the three (3) stents appeared to be at the top of the scleral spur, and the other two (2) stents appeared to be sitting "low" in the trabecular meshwork (tm).Reportedly, the patient was treated with medication.Through follow-up, the surgeon consulted with a medical expert who reported discussing the surgeon's issue with stent positioning.Per report, surgical technique including intraoperative visualization of the pigmented trabecular meshwork (tm), increasing magnification, and ensuring that the viscoelastic isn't "burping out" were discussed.The report noted that the surgeon feels she is consistently implanting them low.Additional information is being 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: 18222443
• MDR Text Key: 329197865
• Report Number: 2032546-2023-00132
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female