FDA Adverse Event
Malfunction
Summary report: N
AXIUM 3-D DETACHABLE COIL
MDR report key: 2972438
·
Received February 21, 2013
Report
- Report Number
- 2029214-2013-00135
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- January 21, 2013
- Report Date
- January 22, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION.(B)(4).
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED FOR EVALUATION WITH THE IMPLANT COIL ATTACHED TO THE PUSHER ASSEMBLY. THE DEVICE WAS EVALUATED AND THE IMPLANT COIL DETACHED NORMALLY VIA THE MANUAL METHOD (WHICH IS AN ALTERNATE DETACHMENT METHOD PRESENTED IN THE INSTRUCTIONS FOR USE).(B)(4).
Description of Event or Problem · 1
TREATMENT OF AN ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE IMPLANT COIL WOULD NOT DETACH DESPITE SEVERAL ATTEMPTS 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 |
|---|---|---|---|---|---|---|---|
| 76764 | AXIUM 3-D DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-3-4-3D | 9656216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |