FDA Adverse Event
Malfunction
Summary report: N
AXIUM 3-D DETACHABLE COIL
MDR report key: 1182698
·
Received September 25, 2008
Report
- Report Number
- 2029214-2008-00168
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- July 16, 2008
- Report Date
- August 27, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- 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 AN ANEURYSM. IT WAS REPORTED THE COIL PREMATURELY DETACHED AND WAS IMPLANTED. 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-22-50-3D | 4449363 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |