MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-24 for HYDRUS MICROSTENT F00022 manufactured by Ivantis, Inc..
[185998868]
The hydrus microstent is being returned to the manufacturer for evaluation; the device investigation findings will be provided in a supplemental report. The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings. Microstent malposition, microstent-iris touch, anterior segment inflammation / re-medication with steroids, pupil irregularity, and microstent explantation are listed in the device labeling as potential adverse events. Manufacturer reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185998869]
The surgeon contacted ivantis regarding the position of the hydrus microstent in one of his patients, who had undergone implantation approximately 2-3 weeks prior. One day postoperatively, the intraocular pressure (iop) was 24 mmhg in the operative eye, increasing to 30 mmhg at day 5. The surgeon reported difficulty visualizing the device windows and the distal end of the microstent was positioned too far out in the anterior chamber / close to the iris; in addition, the area near the device appeared more fibrotic. Durezol was prescribed to address 2+ cells in the anterior chamber and the patient was scheduled for device repositioning or explantation. In early march the microstent was explanted and an alternate glaucoma device was implanted; the surgeon had attempted to reposition the hydrus, but was unable to achieve proper positioning. Additional information was requested. On march 23, 2020, the doctor's office reported the following details. A (b)(6) year-old male patient underwent implantation of the hydrus microstent in the left eye on (b)(6) 2020. The hydrus was implanted in combination with cataract surgery and endoscopic cyclophotocoagulation and there were no intraoperative complications. Preoperatively, the patient's iop was 28 mmhg on 2 iop-lowering topical glaucoma medications with a best corrected visual acuity (bcva) of 20/25. At the postoperative examination on (b)(6) 2020, gonioscopy was performed and the stent was in good position; at this visit the iop was 24 mmhg (on 1 iop lowering medication) with 20/30 bcva. At the examination on (b)(6) 2020, 4+ pigment was observed, and the stent appeared to be contacting the iris, causing some iris retraction and ectopic pupil. At this visit, the iop was 25 mmhg (on 1 iop-lowering medication) with 20/25 bcva. The microstent was explanted on (b)(6) 2020 and the pupil normalized upon removal. Post-explant, the iop was 20 mmhg (on 2 iop-lowering medications) with 20/20 bcva.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007683266-2020-00011 |
| MDR Report Key | 9876012 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-10-22 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HELENE SPENCER |
| Manufacturer Street | 201 TECHNOLOGY |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 6009650130 |
| Manufacturer G1 | IVANITS, INC. |
| Manufacturer Street | 38 DISCOVERY SUITE 150 |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDRUS MICROSTENT |
| Generic Name | INTRAOCULAR PRESSURE LOWERING IMPLANT |
| Product Code | OGO |
| Date Received | 2020-03-24 |
| Model Number | F00022 |
| Catalog Number | F00022 |
| Lot Number | 19900507 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVANTIS, INC. |
| Manufacturer Address | 201 TECHNOLOGY IRVINE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |