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

Model Number	IS3-US
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that following a cataract surgery, the surgeon noticed that the trocar tip was missing during attempt to implant the stents from a trabecular microbypass stent system.Per report, a back-up device was used to complete the procedure.There was no report of patient injury.Additional information has been requested.
Additional 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 complaint history review was completed.The electronic complaint system was searched for the specified lot#.There were no similar issues reported for this lot #.A review of the device labeling including the risk analysis was completed.The reported issue (trocar fragmentation) is identified to be an anticipated hazard.The residual risk for each potential harm was found to be within the insignificant risk region.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Mfr# reference: (b)(4).
Additional Manufacturer Narrative
The additional information received through follow-up was reassessed for reportability criteria; and concluded that the reported event no longer meets the statutory definition of a medical device reportable event.Based on the clarification received, glaukos no longer considers this report as a reportable event.Mfr# reference: (b)(4).
Event or Problem Description
Through follow-up, the following additional information was received.Contrary to the initial report of a broken trocar, the surgeon reportedly observed that the trocar was "bent" on the end in the packaging.Per report, the event was noted as resolved in the operative eye (os) with no adverse patient impact or intervention required, and the patient is stable with a good stent (from the back-up device) and good intraocular pressure (iop).

• Brand Name: ISTENT INFINITE TRABECULAR MICRO-BYPASS SYSTEM
• Common Device Name: AQUEOUS SHUNT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA
• 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: 20077796
• Report Number: 2032546-2024-00094
• Device Sequence Number: 12662271
• Product Code: KYF
• UDI-Device Identifier: 00853704002449
• UDI-Public: 0100853704002449
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K220032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: IS3-US
• Device Lot Number: 318524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female