AXIUM 3D Adverse Event — Malfunction (MDR 2029214-2020-00405)
AXIUM 3D Adverse Event — Malfunction (MDR 2029214-2020-00405) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AXIUM 3D; Generic name: DEVICE, EMBOLIZATION, VASCULAR; Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3.
| Device | AXIUM 3D |
|---|---|
| Generic name | DEVICE, EMBOLIZATION, VASCULAR |
| Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 |
| Report number | 2029214-2020-00405 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THE AXIUM COIL HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, PRODUCT ANALYSIS CANNOT BE PERFORMED. THE DEVICE WAS NOT RETURNED; THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CAUSE OF THE EVENT CANNOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
| Source | openFDA MAUDE (device adverse events) |
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