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

Model Number	GTS100L
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(the stent was not implanted in the proper location and it is unknown where the stent is, therefore the surgery date was indicated in the implant date field.) the device remains in the patient, therefore product testing on the 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.In addition a complaint history review was completed for this lot, there were no complaints found to be related to the reported event.A review of the device labeling was completed.Malpositioned stents identified in the labeling as a known inherent risk of intraocular surgery.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Any omitted information was not available at the time of initial report.Written correspondence will be sent to the surgeon requesting the outstanding information.Subsequent attempts will be made as necessary (b)(4).
Event or Problem Description
As reported during a trabecular micro-bypass stent surgical procedure of the left eye, ¿there was too much blood¿ and the stent was lost either inside or outside of the patient¿s eye.The surgeon attempted to visualize the stent using an endoscopic camera, but was unable to locate the stent.The trabecular micro-bypass stent surgery was aborted.There was no patient injury.Additional information will be requested.
Additional Manufacturer Narrative
Mfr reference # (b)(4).
Event or Problem Description
Clinical follow-up was requested and on 05/02/2018 the surgeon provide the following clarification.Contrary to initial report of stent lost in the eye, it was learned that the stent was actually lost after removing it from the patient''s eye and therefore did not result in adverse impact to the patient.Since the stent was unable to be implanted in conjunction with cataract surgery, the surgeon performed endoscopic cyclophotocoagulation (ecp) as an alternative treatment for the patient¿s glaucoma.

• 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: 7474797
• Report Number: 2032546-2018-00037
• Device Sequence Number: 13716077
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 00853704002012
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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: 11/30/2020
• Device Model Number: GTS100L
• Device Catalogue Number: GTS100L
• Device Lot Number: 113854
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR