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

Model Number	GTS100R
Medical Device Problem Codes	Obstruction of Flow (2423); Malposition of Device (2616)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Uveitis (2122); Foreign Body In Patient (2687)
Date of Event	10/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 believed to be related to the reported event.Malpositioned stent, stent obstruction, iop elevation, decreased vision, and uveitis are identified in the device labeling as known inherent risks of glaucoma stent surgery.(b)(4).Submitted to fda: 11-3-2016.
Event or Problem Description
The surgeon reported that an istent patient presented postoperatively with iop spikes which were at first thought to be steroid responder related.During postoperative gonioscopy exam the surgeon reported that the istent was implanted in the trabecular meshwork and tilted with iris obstructing the opening of the stent.A medical monitor consult was initiated on (b)(6) 2016.Clinical follow up was requested and on 10/27/2016 the surgeon provided the following details.Cataract surgery with istent implantation was uneventful.The status of the implanted stent as confirmed by postoperative imaging was reported to be malpositioned.The malpositioning resulting in uveitis and pressure spikes.The stent is planned to be explanted on (b)(6) 2016.The patient continues to have uveitis, ocular hypertension and decreased visual acuity.Additional information will be requested.
Additional Manufacturer Narrative
Additional information: pt identifier, age/date of birth, describe event or problem, explant date, device available for evaluation?, device evaluated by mfr?, evaluation codes.(b)(4).Submitted to fda on 11/21/2016.
Event or Problem Description
The surgeon reported that the istent was explanted on (b)(6) 2016 and that another istent was not implanted.Additional information has been requested.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the stent found no issues with the stent.(b)(4).
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Clinical follow up was requested and on (b)(6) 2017, the surgeon provided to following additional event details.The istent was explanted and the patient will require a trabeculotomy for the ongoing elevated iop.At the time of the initial postop, iop elevation the patient was on the same glaucoma medications as compared to pre-op and was compliant.In the surgeon's opinion the iop elevation was caused by the patient's worsening of their preexisting ocular hypertension/glaucoma disease.

• 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: 6077088
• Report Number: 2032546-2016-00067
• Device Sequence Number: 16348194
• Product Code: OGO
• UDI-Device Identifier: 00853704002005
• UDI-Public: 0100853704002005101079221719063021107922US0218
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P080030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/12/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: GTS100R
• Device Lot Number: 107922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/11/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 11/03/2016
• Supplement Report FDA Received Date: 11/21/2016; 01/03/2017; 01/12/2017
• 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: 85 YR