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

Model Number IS3-WW

Device Problem Malposition of Device (2616)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/28/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information: date based on universal time coordinated (utc).The device remains implanted in the patient; 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.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.The reported event 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 was likely due to intraoperative operational context- compromised intraoperative visualization.(b)(4).

Event Description

It was reported that during a right eye (od) a trabecular microbypass stent system procedure, the first stent from the back-up device was inadvertently implanted below the trabecular meshwork (tm) in the scleral spur.There was no report of patient injury, and the procedure was completed with a successful implant of the second stent from the back-up device.The report that noted compromised intraoperative view contributed to the reported event.Any omitted information was not available at the time of report.

Manufacturer Narrative

Additional information: g3, g4.A review of the surgical video confirmed the reported event.Based on the investigation and available information, the root cause of the stent malpositioning could not be conclusively identified; however it is possible that surgical technique may have been contributed to the event.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
• Manufacturer Contact: 229 avenida fabricante; san clemente, CA 92672 ; 949367960
• MDR Report Key: 15618900
• MDR Text Key: 306407910
• Report Number: 2032546-2022-00111
• Device Sequence Number: 1
• Product Code: KYF
• UDI-Device Identifier: 00853704002470
• UDI-Public: 0100853704002470
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K220032
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: IS3-WW
• Device Lot Number: 112718
• 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: 09/30/2021
• 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