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	Eye Injury (1845); Hyphema (1911); Intraocular Pressure Increased (1937); Loss of Vision (2139)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to the manufacturing site as it was not available for evaluation; therefore product testing on this 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 part of the device history records review the sterilization records for this lot were reviewed and this device lot passed sterility test.A review of the device labeling was completed.Iris damaged is identified in the labeling as known inherent risk of trabecular micro-bypass stent surgery.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Based on the results of the investigation to date, a quality product deficiency was not identified.Any omitted information was not available at the time of initial report.Written correspondence has been sent to the surgeon requesting the outstanding information.Subsequent attempts will be made as necessary.Mfr reference: (b)(4).
Event or Problem Description
The surgeon reported that during the istent procedure while having the istent in the angle, and just beginning his initial approach to the trabecular meshwork, the patient moved and the surgeon tried to quickly remove the inserter from the eye.The surgeon inadvertently snagged the iris and caused a two clock hour iridodialysis.The surgery was aborted.The surgeon indicated that the patient was doing "better" one day postop.Additional information will be requested.
Event or Problem Description
The surgeon provided the following additional information to glaukos on 07/02/2018.The istent procedure was aborted due a grade i hyphema (less than or equal to 1/3 anterior chamber vol.) which resulted in iop elevation and "temporary bcva loss.The hyphema was treated by increasing steroids and dilatation drops.Pars plana vitrectomy (ppv) and anterior chamber washout were performed one month post-op.The patient was prescribed combigan and lumigan and will continue to be monitored.According to the surgeon, the adverse event resolved, and hyphema likely contributed to the reported event.The patient current status was reported as "improved, vision back to baseline".
Additional Manufacturer Narrative
Mfr reference # 17187.
Event or Problem Description
The surgeon provided the following additional information on 05/30/2018.Reportedly, following an uneventful cataract surgery, vitreous hemorrhage was noted after severe patient movement while the trabecular micro-bypass stent was still in the eye (prior to stent deployment).The iris damage was characterized as permanent, observed at the nasal quadrant, measuring 2 clock hours and resulted in hyphema.The surgeon indicated that medical intervention was required and surgical intervention is likely required to washout anterior chamber.The patient¿s prognosis was reported as persistent ¿marked hyphema¿.Additional information is being requested.
Additional Manufacturer Narrative
A review of the device labeling was completed.Hyphema, iop increase and decreased/impaired vision are identified in the labeling as known inherent risks of trabecular micro-bypass stent surgery.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Additional information is being requested.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 CA 92672
• MDR Report Key: 7520753
• Report Number: 2032546-2018-00046
• Device Sequence Number: 11228231
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 00853704002012
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P080030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2018

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: 01/31/2021
• Device Model Number: GTS100L
• Device Catalogue Number: GTS100L
• Device Lot Number: 114312
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 05/30/2018; 07/02/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 06/20/2018; 07/19/2018
• 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: Other
• Patient Age: 79 YR