FDA Adverse Event
Malfunction
Summary report: N
AXIUM 3-D DETACHABLE COIL
MDR report key: 3050461
·
Received April 10, 2013
Report
- Report Number
- 2029214-2013-00344
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- March 13, 2013
- Report Date
- March 13, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION.(B)(4).
Description of Event or Problem · 1
DURING THE PROCEDURE, IT WAS REPORTED THAT THE AXIUM IMPLANT COIL WOULD NOT DETACH AFTER IT WAS POSITIONED IN THE ANEURYSM AND WAS REMOVED FROM THE PATIENT.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148033 | AXIUM 3-D DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-3-4-3D | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |