MAUDE Adverse Event Report: GLAUKOS CORPORATION ISTENT INJECT TRABECULAR MICRO BYPASS SYSTEM; INTRAOCULAR PRESSURE LOWERING IMPLANT

Model Number	G2-M-IS
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices remain in the patient's eye; thus, date of implant is indicated.The delivery device was returned to glaukos, and undergoing evaluation.The device history record review of the manufacturing lot was performed and there were 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.Based on the information received, the root cause of the reported event was due to technique/experience with the device.(b)(4).
Event or Problem Description
It was reported that during a cataract plus trabecular micro bypass stent procedure, the surgeon inadvertently deployed two (2) stents posteriorly to the trabecular meshwork (tm) intraoperatively.A backup device was used to implant two (2) stents successfully in the tm.The malpositioned stents remain in the patient¿s eye, and there was no report of patient injury.Additional information has been requested.
Additional Manufacturer Narrative
Additional information:a2, b, b6, b7, g3.Correction: a3.Mfr# reference (b)(4).
Event or Problem Description
Through follow-up, the following additional information was provided.Reportedly, the stent positioning did not result in any adverse impact and there was no secondary surgical intervention required.Per report, the patient underwent a second cataract procedure, and a yag capsulotomy was performed on (b)(6) 2020 (unrelated to the stent).The patient¿s prognosis was reported as ¿event resolved¿.
Additional Manufacturer Narrative
Additional information: evaluation of the returned device was completed.X-ray evaluation revealed that the cam assembly had been activated 2 times and no stents were found.The trigger button motion was functioning as intended as the device was able to actuate all remaining positions.The device was disassembled and visually inspected.No non-conformances were found.Based on these findings, the root cause of the customer¿s reported issue was not conclusively identified.Mfr# (b)(4).

• Brand Name: ISTENT INJECT TRABECULAR MICRO BYPASS SYSTEM
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• MDR Report Key: 10192986
• Report Number: 2032546-2020-00051
• Device Sequence Number: 3014472
• Product Code: OGO
• UDI-Device Identifier: 00853704002203
• UDI-Public: 0100853704002203
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P170043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2020
• Report Date (Section F): 01/01/2005

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: 12/31/2022
• Device Model Number: G2-M-IS
• Device Lot Number: 128219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 07/07/2020; 08/03/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/27/2020; 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005