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

Model Number	GTS1000R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded by the customer and is not available for evaluation.The device history records were reviewed for this manufacturing lot and there were no non-conformities found to be related to the reported event.The device labeling addresses the design, which mitigates against this alleged malfunction.The stent has a single piece design manufactured from titanium.Implant grade titanium (astm-f136 compliant) is well documented in the literature to be a strong, medical grade, biocompatible implant material that can be used in ophthalmic, dental and orthopedic applications for 20 years or longer.No previous incidences of stent fracture have been reported in the gts100 u.S.Pivotal trial, ous pms studies, commercial complaint system or the literature.We are unable to confirm a device malfunction as the product was discarded and is not available for evaluation.(b)(4).
Event or Problem Description
The surgeon initially reported that the stent fell off the inserter.While attempting to regrasp the stent, prior to inserting the device into the eye, the stent ¿crumbled.¿ follow-up was requested and on 04/13/2017 the surgeon provided the following event details.The surgeon attempted to implant the stent, but was unable to get it into the canal.The stent was regrasped and observed to be seated on the inserter in a ¿cockeyed¿ manner.After removing the device from the eye, the surgeon viewed the istent under the microscope and noted that the stent appeared bent.The stent was released from the inserter, and fragmented at the area between the snorkel and body.A backup stent was implanted without incident.

• 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: 6505596
• Report Number: 2032546-2017-00025
• Device Sequence Number: 13532191
• Product Code: OGO
• UDI-Device Identifier: 00853704002005
• UDI-Public: 01008537040020051010923617191130
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P080030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2017

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: 11/30/2019
• Device Model Number: GTS1000R
• Device Lot Number: 109236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 04/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR