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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endophthalmitis (1835); Visual Impairment (2138)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: the device was not available; therefore, product testing on the actual device could not be performed.The device history records were reviewed for this manufacturing lot and there were no non-conformities found to be related to the reported event.As part of the device history records review, the sterilization records for this lot were reviewed and the device was sterilized and released according to the product's acceptance criteria.A complaint history review was completed.The electronic complaint system was searched for lot 123779.There were no similar issues reported for this lot #.A review of the device labeling was completed.Endophthalmitis and decreased/impaired vision are identified in the labeling as known inherent risks of cataract/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.Endophthalmitis is an inherent risk of any ocular surgery and the etiology of the infection in this case is not known.Based on the results of the investigation, no quality product deficiency was identified.As reported- the facility's sterilizer was not working at the time, and the facility was "flashing all reusable surgical instruments." based on the information received and the investigation findings, the facility¿s lack of a functioning sterilizer (at that time) likely contributed to the reported event.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that following uneventful right eye cataract plus trabecular micro bypass stent system procedure, the patient presented on post-op day one (1) with endophthalmitis associated with decreased visual acuity.Per report, the patient was referred to a specialist.The report noted that the facility's sterilizer was not working at the time, and the facility was "flashing all reusable surgical instruments." additional information has been requested.

• 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: 9555681
• Report Number: 2032546-2020-00003
• Device Sequence Number: 3403519
• Product Code: OGO
• UDI-Device Identifier: 00853704002203
• UDI-Public: 0100853704002203
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P170043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2020
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: G2-M-IS
• Device Lot Number: 123779
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Date Report Sent to FDA: 01/01/2005