MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-16 for AXIUM FRAMING COIL FC-25-50-3D manufactured by Micro Therapeutics, Inc. Dba Ev3.
[183939141]
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.
Patient Sequence No: 1, Text Type: N, H10
[183939142]
Medtronic received information that this axium implant coil would not able to detach during the procedure. Reported device and any accessory devices were prepared as indicated in the ifu. No further detail provided at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00238 |
| MDR Report Key | 9836990 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-03-27 |
| Date Added to Maude | 2020-03-16 |
| 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 | MGR. KATCHA TAYLOR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801345 |
| Manufacturer G1 | MICRO THERAPEUTICS, INC. DBA EV3 |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXIUM FRAMING COIL |
| Generic Name | DEVICE, EMBOLIZATION, VASCULAR |
| Product Code | KRD |
| Date Received | 2020-03-16 |
| Model Number | FC-25-50-3D |
| Lot Number | A805539 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |