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 Problem Foreign Body In Patient (2687)

Event Date 12/19/2023

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.Malpositioned 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.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.Malpositioned stent is an established risk 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.Mfr# reference: (b)(4).

Event Description

It was reported that following a trabecular microbypass stent system procedure, the patient presented approximately three (3) months postop with a loose stent in the inferior angle.There was no report of adverse patient impact.Through follow-up, the surgeon conferred with glaukos medical monitor who reported discussing the stent''s position in the angle recess, and monitoring over the next few visits as it remains away from the cornea.Additional treatment options were discussed based on the stent''s positioning.Per report, the patient is currently doing well.Additional information is being requested.

Manufacturer Narrative

Additional information: d4 (lot#, serial#, exp.Date, udi#).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.Mfr# reference: (b)(4).

Event Description

Through follow-up, the following additional information was received.The surgeon reported an uneventful left eye (os) cataract surgery, followed by stent implantation.Per report, the malpositioned stent did not result in any adverse impact to the patient, and did not require intervention.The report noted that the patient is being monitored, and the event is ongoing with a loose stent in the inferior angle which is not causing any issues.

• 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: 18471786
• MDR Text Key: 332987204
• Report Number: 2032546-2024-00005
• 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,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS3-US
• Device Lot Number: 313213
• 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: 08/24/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Male