FDA Adverse Event
Injury
Summary report: N
AXIUM 3-D DETACHABLE COIL
MDR report key: 2001409
·
Received February 25, 2011
Report
- Report Number
- 2029214-2011-00038
- Event Type
- Injury
- Date Received
- February 25, 2011
- Date of Event
- January 27, 2011
- Report Date
- January 27, 2011
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. (B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THE COIL COULD NOT BE DETACHED. UPON REMOVAL, THE COIL DETACHED INSIDE THE CATHETER. THE PHYSICIAN WAS ABLE TO PUSH THE COIL INTO THE ANEURYSM WITH THE PUSHWIRE.NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIUM 3-D DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-5-15-3D | 7306770 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |