FDA Adverse Event
Injury
Summary report: N
AXIUM 3-D DETACHABLE COIL
MDR report key: 1111739
·
Received August 13, 2008
Report
- Report Number
- 2029214-2008-00138
- Event Type
- Injury
- Date Received
- August 13, 2008
- Date of Event
- July 16, 2008
- Report Date
- July 16, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED FOR EVALUATION AND THE IMPLANT COIL WAS FOUND DETACHED. EVALUATION OF THE PUSHER ASSEMBLY COULD NOT DETERMINE THE CAUSE OF THE EVENT AS PART OF THE PUSHER ASSEMBLY WAS NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
COILING TREATMENT OF AN ICA ANEURYSM. IT WAS REPORTED THE COIL COULD NOT BE DETACHED AFTER SEVERAL ATTEMPTS. UPON REMOVAL, THE COIL DETACHED OUTSIDE. NO PT 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-4-12-3D | 5887392 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |