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 Adhesion(s) (1695)

Event Date 02/17/2023

Event Type  Injury  

Event Description

It was reported that during a postop examination following a left eye (os) trabecular microbypass stent procedure, the patient presented with stent obstruction associated with mild peripheral anterior synechiae (pas).Per report the stent could not be visualized due to the pas.The report noted that no intervention is required, and the event is ongoing.Additional information has been requested.

Manufacturer Narrative

Additional information: the device was not available; therefore, product testing on the actual device could not be performed.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.A review of the device labeling was completed.Stent obstruction is identified in the labeling as a known inherent risk of trabecular micro-bypass aqueous shunt 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 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.Mfr# reference: (b)(4).

• 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 ; 949367960
• MDR Report Key: 16545823
• MDR Text Key: 311318204
• Report Number: 2032546-2023-00024
• Device Sequence Number: 1
• Product Code: KYF
• UDI-Device Identifier: 00853704002449
• UDI-Public: 0100853704002449
• Combination Product (y/n): N
• Reporter Country Code: HO
• PMA/PMN Number: K220032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: IS3-US
• Device Lot Number: 300308
• 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: 11/01/2021
• 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 Age: 67 YR
• Patient Sex: Female