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 2020-01-09 for ISTENT INJECT TRABECULAR MICRO BYPASS SYSTEM G2-M-IS manufactured by Glaukos Corporation.
[174600762]
Additional information: the device was not available; therefore, product testing on the actual device could not be performed. The device identifiers were not provided; therefore, the device history records for this device lot number could not be reviewed. A review of the device labeling was completed. Elevated iop is identified in the labeling as a known inherent risk of trabecular micro-bypass stent procedure. The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device. An adverse event appears to have occurred, but the information received does not suggest a problem with the device or the way it was used. Based on the information received, the root cause of the reported event was likely due to cessation of steroids. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[174600763]
It was reported that following cataract plus trabecular micro bypass stent system, the patient presented with iop spike approximately one (1) week postoperatively. The patient was prescribed glaucoma medication (alphagan) and the iop decreased subsequently. Per report, the surgeon acknowledged that steroids cessation at day one (1) postop likely contributed to the iop spike. The stents were reportedly in good position following via gonio examination. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032546-2020-00007 |
| MDR Report Key | 9570354 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-09 |
| Date of Event | 2019-12-20 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-12-20 |
| Date Added to Maude | 2020-01-09 |
| 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 | MRS. BRITTANY MASSEY |
| Manufacturer Street | 229 AVENIDA FABRICANTE |
| Manufacturer City | SAN CLEMENTE CA 92672 |
| Manufacturer Country | US |
| Manufacturer Postal | 92672 |
| Manufacturer Phone | 949367960 |
| Manufacturer G1 | GLAUKOS CORPORATION |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISTENT INJECT TRABECULAR MICRO BYPASS SYSTEM |
| Generic Name | INTRAOCULAR PRESSURE LOWERING IMPLANT |
| Product Code | OGO |
| Date Received | 2020-01-09 |
| Model Number | G2-M-IS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAUKOS CORPORATION |
| Manufacturer Address | 229 AVENIDA FABRICANTE SAN CLEMENTE CA 92672 US 92672 |
| Brand Name | ACETAMINOPHEN 500MG |
| Product Code | --- |
| Date Received | 2020-01-09 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | MANUFACTURE / COMPOUNDER NAME |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-09 |