FDA Adverse Event
Death
Summary report: N
AXIUM DETACHABLE COIL SYSTEM
MDR report key: 1288610
·
Received January 14, 2009
Report
- Report Number
- 2029214-2009-00008
- Event Type
- Death
- Date Received
- January 14, 2009
- Date of Event
- October 22, 2008
- Report Date
- November 25, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS CONSUMED IN THE EVENT. REGISTRY PERTAINING TO THE EVALUATION OF AXIUM DETACHABLE COILS IN THE TREATMENT OF INTRACRANIAL ANEURYSMS. PROSPECTIVE, MULTI-CENTER IN OTHER COUNTRIES. ENROLLMENT STARTED IN 2008; ENROLLMENT ONGOING. TARGET 300 PATIENTS. MDR NUMBERS: 2029214-2008-00207 TO 2029214-2008-00237 AND 2029214-2009-00007 TO 202914-2009-00014.
Description of Event or Problem · 1
INFORMATION FROM CLINICAL TRIAL DATABASE FATAL VASOSPASM. COILS USED: QC-7-20-3D; QC-5-15-HELIX; QC-2-6-HELIX; QC-2-4-HELIX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIUM DETACHABLE COIL SYSTEM | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-7-20-3D | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Death |