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

Model Number GTS100L

Device Problems Occlusion Within Device (1423); Device Dislodged or Dislocated (2923)

Patient Problems Macular Edema (1822); Intraocular Pressure Increased (1937); Uveitis (2122)

Event Date 02/01/2015

Event Type  Injury  

Event Description

Cataract surgery with implantation of the istent was performed in (b)(6) 2014.Recently the patient's iop had been increasing so the surgeon performed gonioscopy and observed that the iris seemed to be covering the stent, which is no longer visible.The patient's iop is being managed with glaucoma drops.Additional details were provided by the optometrist who has been following the patient.The stent is not in the same position and has tilted and pas developed.Yag laser surgery was attempted in (b)(6) 2015.Since then the patient presented with uveitis and cystoid macular edema with elevated iop.The patient has been treated with glaucoma medications and anti-inflammatory medications (subconjunctival steroid injection).Additional information has been requested.

Manufacturer Narrative

The stent remains in the patient and is not available for evaluation.No device identifiers are available at this time.Uveitis, pas, cme, stent obstruction, and stent dislocation are listed in the device labeling as known inherent risks of glaucoma stent surgery.(b)(4).

Manufacturer Narrative

The device history records were reviewed and there were no findings that relate to the reported event.

Event Description

The following add'l info was provided by the surgeon.The pt underwent uneventful istent surgery in the right eye on (b)(6) 2014.The pt's preoperative bcva was 20/25 and preoperative iop was 26 mmhg.The pt was examined on (b)(6) 2014 and the iris was covering the stent.On (b)(6) 2014, a yag laser procedure was performed to address the stent occlusion; the stent was opened, but the procedure had to be stopped due to heme.On (b)(6) 2015, the pt underwent a trabeculectomy with implantation of the express shunt.On (b)(6) 2015, the pt's bcva was 20/20.Pt's current status is listed as good visual acuity, iop 16-18 mmhg, but with meds goes down to 12 mmhg, on no meds at this time.Using 3 meds in fellow eye.It was noted that the cme is secondary to vitreomacular adhesion.

• Brand Name: ISTENT TRABECULAR MICRO-BYPASS
• Type of Device: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): GLAUKOS CORP.; laguna hills CA
• Manufacturer Contact: jeff wells ; 26051 merit circle; ste 103; laguna hills, CA 92653 ; 9493679600
• MDR Report Key: 4687482
• MDR Text Key: 5638150
• Report Number: 2032546-2015-00012
• Device Sequence Number: 1
• Product Code: OGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: GTS100L
• Device Lot Number: 103165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR