FDA Adverse Event
Malfunction
Summary report: N
AXIUM 3-D DETACHABLE COIL
MDR report key: 1193405
·
Received October 7, 2008
Report
- Report Number
- 2029214-2008-00179
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 16, 2008
- Report Date
- September 19, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUSHER ASSEMBLY WAS RETURNED FOR EVALUATION AND CONFIRMED THE IMPLANT COIL HAD DETACHED, BUT THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT.
Description of Event or Problem · 1
COILING TREATMENT OF A LEFT MCA ANEURYSM. IT WAS REPORTED THE COIL COULD NOT BE DETACHED. WHILE PULLING IT BACK OUTSIDE OF THE PATIENT, THE COIL DETACHED ON THE TABLE. 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-20-50-3D | 5038350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |