FDA Adverse Event
Injury
Summary report: N
AXIUM 3-D DETACHABLE COIL
MDR report key: 1230524
·
Received November 12, 2008
Report
- Report Number
- 2029214-2008-00197
- Event Type
- Injury
- Date Received
- November 12, 2008
- Date of Event
- October 16, 2008
- Report Date
- October 15, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS IMPLANTED IN THE PATIENT.
Description of Event or Problem · 1
COILING TREATMENT OF A RUPTURED ICA BIFURCATION ANEURYSM. IT WAS REPORTED AN AXIUM COIL WAS DEPLOYED AND IT MODIFIED THE SHAPE OF THE ANEURYSM. THE PROCEDURE WAS CONTINUED WITH ADDITIONAL COILS. A FINAL ANGIOGRAPHIC CONTROL FOR COIL PLACEMENT WAS PERFORMED AND REPORTED FINE. A CT SCAN WAS PERFORMED AND SHOWED LITTLE HEMORRHAGE LOCALIZED AT RIGHT FRONTAL BASAL AND REPORTED THE HEMORRHAGE INCREASED DURING THE NIGHT. THE PATIENT STATUS WAS REPORTED AS "SEVERE GRADE, DUE TO HYPERTENSION".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIUM 3-D DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-4-8-3D | 6510723 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Disability |