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	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: the device is expected to be returned for evaluation but has not been received at glaukos evaluation center.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).
Event or Problem Description
It was reported that the trocar broke during attempt to implant the stents from a trabecular microbypass stent system.Per report, no stents were implanted and "nothing was left in the eye." additional information has been requested.
Additional Manufacturer Narrative
The evaluation of the returned device was completed, and the x-ray revealed that the device was in the third singulated position, and no stents were returned.The singulation slide motion, implantation button motion, and introducer sleeve subassembly motion were not functioning properly due to bent frontal components.The injector¿s frontal components were found bent, and the trocar was not secured in the carrier.These findings likely occurred due to how the device was returned.All devices undergo visual inspection via x-ray per manufacturing internal procedures.A review of x-ray images for the linked manufacturing index on the device housing revealed that the accepted injector contained three (3) splays and three (3) stents on the trocar that met the required specifications.If any of the frontal components were bent during x-ray, the unit should get rejected.The device was disassembled and visually inspected.No non-conformances related to the reported event were found.The associated device history record (dhr) for the injector assembly for this lot was reviewed, and no issues were found.All devices undergo visual inspection per manufacturing internal procedure.If the trocar was not seated properly during visual inspection, the unit should get rejected.Therefore, it is highly unlikely that the trocar was shipped dislodged from the carrier.Conclusions based on the evaluation findings were confounded by the condition of the returned product.As a result, a root cause of the reported issue was not definitively identified.Mfr# reference: (b)(4).

• Brand Name: ISTENT INFINITE TRABECULAR MICRO-BYPASS SYSTEM
• Common Device Name: 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: 20326697
• Report Number: 2032546-2024-00110
• Device Sequence Number: 12665749
• Product Code: KYF
• UDI-Device Identifier: 00853704002449
• UDI-Public: 01008537040024491031844817260228
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: 02/28/2026
• Device Model Number: IS3-US
• Device Lot Number: 318448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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: Unknown