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); Hypopyon (1913); Loss of Vision (2139)
Date of Event	05/20/2019
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.A review of the device labeling was completed.Endophthalmitis is identified in the labeling as a known inherent risk of trabecular micro-bypass stent/cataract procedure.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 following a left eye cataract procedure, the surgeon was unable to implant one (1) of the two (2) stents from a trabecular micro bypass stent system.On postop day six (6), the patient presented with endophthalmitis.Additional information is being requested.
Event or Problem Description
Through follow-up, the surgeon provided the following additional information.The patient presented with postop hypopyon and endophthalmitis associated with methicillin-resistant staphylococcus aureus (mrsa).Pars plana vitrectomy (ppv) was performed with intravitreal antibiotics.The patient status was reported as ¿light perception with guarded prognosis¿.Reportedly, the patient was offered surgery by retinal specialist, but declined.
Additional Manufacturer Narrative
A review of the device labeling was completed.Hypopyon and decreased/impaired vision is identified in the labeling as a known inherent risk of trabecular micro-bypass stent/cataract procedure.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
Additional information: a complaint history review was completed for this lot, there were no complaints found to be related to the reported event.Mfr# reference: (b)(4).
Additional Manufacturer Narrative
Mfr# reference: (b)(4).H3 other text : placeholder.
Event or Problem Description
Clinical follow-up was requested and the surgeon provided the following additional information.On postop day one (1) the patient presented with postop inflammation described as 1+ flare and cell.Reportedly, the patient experienced ¿loss of vision and pain in operative eye¿ on postop day four (4).The patient was evaluated later the same day by the surgeon and presented with postop inflammation described as hypopyon.An eye culture was obtained and the results showed methicillin-resistant staphylococcus aureus (mrsa) positive.Pars plasma vitrectomy and intravitreal antibiotic injections were performed to treat the inflammation.According to the surgeon, the likely cause of the inflammation was ¿most common staphylococcus epidermidis¿.The patient prognosis was reported as ¿very poor and further surgery may be needed¿.The patient remains with no vision in the left eye and therefore the surgeon questioned additional surgery as the risks outweigh the benefits.

• 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: 8665030
• Report Number: 2032546-2019-00090
• Device Sequence Number: 11292165
• Product Code: OGO
• UDI-Device Identifier: 00853704002203
• UDI-Public: 0100853704002203
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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,Followup,Followup,Followup
• Report Date (Section B): 11/05/2019
• 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: 01/31/2022
• Device Model Number: G2-M-IS
• Device Lot Number: 120960
• 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: 05/20/2019
• Supplement Date Received by Manufacturer: 06/27/2019; 09/17/2019; 10/08/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/17/2019; 09/20/2019; 11/05/2019
• 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: Other
• Patient Age: 85 YR
• Date Report Sent to FDA: 01/01/2005