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

Model Number	GTS100R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	07/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Literature source: zheng cx, moster mr, gogte p, dai y, manzi rs, waisbourd m (2017).Implantation of trabecular micro-bypass stent using a novel ¿landing strip¿ technique.International journal of ophthalmology 2017;10(5):738-741 doi:10.18240/ijo.2017.05.13.Event dates unknown; date article was accepted was used as the date of the event.Preoperative mean iop for all study participants provided.Medical history for entire study population provided.The device remains implanted in the patient 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.Any omitted information is not available.Written correspondence was sent to the surgeon and all information known was reported.Elevated iop is identified in the device labeling as a known inherent risk of glaucoma stent surgery.It is indicated in the device labeling that "the safety and effectiveness of the istent trabecular micro-bypass stent has not been established in patients with pseudoexfoliative glaucoma and pigmentary glaucoma, because the pivotal trial was not powered to evaluate outcomes of these groups." mfr reference # (b)(4).Refer to mdr #2032546-2017-00067 for the second istent patient requiring trabeculectomy in this article.
Event or Problem Description
Through review of the article "implantation of trabecular micro-bypass stent using a novel "landing strip" technique" it was learned that following istent implantation, two eyes presented with an increased intraocular pressure (iop) that ultimately required trabeculectomy.The study was comprised of 34 eyes from 30 patients (21 female, 9 male) with a mean age of 74.The istent procedures were completed between may 2014 and february 2015.The purpose of the study was to describe a novel technique of creating a landing strip within the trabecular meshwork to guide trabecular micro-bypass stent (istent) implantation in patients who underwent phacoemulsification.The two patients requiring trabeculectomy initially underwent paracentesis to remove viscoelastic material.One patient continued to have elevated iop ranging from 38-44 mm hg at subsequent follow-up visits.Trabeculectomy was performed three weeks after the istent surgery.Following trabeculectomy, the iop improved to 12 mm hg at the one month follow-up.The article reported that stent failure may have occurred due to aqueous outflow obstruction past schlemm's canal or postoperative trabecular meshwork dysfunction.

• 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: 6805940
• Report Number: 2032546-2017-00066
• Device Sequence Number: 11009310
• Product Code: OGO
• UDI-Device Identifier: 00853704002005
• UDI-Public: 00853704002005
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,literatur
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2017

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: 03/31/2017
• Device Model Number: GTS100R
• Device Catalogue Number: GTS100R
• Device Lot Number: 102896
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 08/18/2017
• 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: 71 YR