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

Model Number	GTS100L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endophthalmitis (1835); Hypopyon (1913); Iritis (1940); Uveitis (2122); Vitrectomy (2643)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 device 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 115795.The (b)(4) complaints were reviewed for similarity.There were no similar issues reported for this lot #.A review of the device labeling was completed.Endophthalmitis is identified in the labeling as a known inherent risk of trabecular micro-bypass stent/intraocular surgery.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Any surgical procedure that disrupts the integrity of the globe can lead to endophthalmitis (eg, cataract, glaucoma, retinal, radial keratotomy, intravitreal injections).Endophthalmitis is an inherent risk of any ocular surgery and the etiology of the infection in this case is not known.  to date, there has been no causal link established between the infection and the istent device.Based on the results of the investigation, no quality product deficiency was identified.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that following cataract plus trabecular micro-bypass stent surgery, the patient presented with endophthalmitis in the operative eye (od) five (5) days post-op.Vitrectomy was subsequently performed on (b)(6) 2018.Additional information has been requested.
Additional Manufacturer Narrative
A review of the device labeling was completed.Iritis, uveitis and hypopyon are identified in the labeling as known inherent risks of trabecular micro-bypass stent/intraocular surgery.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 cannot be determined.(b)(4).
Event or Problem Description
Through follow-up, the surgeon provided the following additional information.The endophthalmitis was associated with iritis, uveitis, and hypopyon.The patient was treated with topical steroids, and pars plana vitrectomy (ppv) was performed.The endophthalmitis was resolving following treatment, and the bcva to be determined eventually.The patient status was reported as ¿still in the stages of recovery¿.
Event or Problem Description
Through follow-up, the following additional information was received.Reportedly, the patient is currently in recovery phase and still clearing inflammatory debris.
Additional Manufacturer Narrative
Mfr# reference: (b)(4).

• Brand Name: ISTENT TRABECULAR MICRO-BYPASS
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente 92672
• MDR Report Key: 7891857
• Report Number: 2032546-2018-00089
• Device Sequence Number: 2725648
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 0100853704002012
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P080030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2018
• 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: 05/31/2021
• Device Model Number: GTS100L
• Device Catalogue Number: GTS100L
• Device Lot Number: 115795
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 09/24/2018; 10/06/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/16/2018; 11/28/2018
• 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: 84 YR
• Date Report Sent to FDA: 01/01/2005