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

Model Number IS3-US

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 07/01/2023

Event Type  malfunction  

Event Description

It was reported that following an uneventful right eye (od) cataract plus trabecular microbypass stent system procedure, the patient presented on postoperative day one (1) with a dislodged stent in the inferior angle.Per report, the patient has three (3) stents placed.Through follow-up, the surgeon conferred with expert opinion md, who reported discussing postoperative management of hyphema, medication, and optimal technical approach.

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/dislocated 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.Dislodged/dislocated 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).

Manufacturer Narrative

Mfr# reference: (b)(4).

Event Description

Through follow-up, the following additional information was received.The surgeon reiterated an uneventful right eye (od) cataract surgery followed by stent implantation.Per report, there was no adverse patient impact, no intervention required, and the patient is being monitored.The most recent patient status was described as "doing well" with the stent remaining in the angle.

• 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: 17390050
• MDR Text Key: 319862504
• Report Number: 2032546-2023-00077
• 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: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• 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
• Patient Sex: Female