FDA Adverse Event
Injury
Summary report: N
AXIUM HELIX DETACHABLE COIL
MDR report key: 1940768
·
Received December 22, 2010
Report
- Report Number
- 2029214-2010-00274
- Event Type
- Injury
- Date Received
- December 22, 2010
- Date of Event
- December 9, 2010
- Report Date
- December 9, 2010
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL NOT BE RETURNED FOR EVAL AS IT WAS IMPLANTED IN THE PT. (B)(4).
Description of Event or Problem · 1
COILING TREATMENT OF AN ANEURYSM. IT WAS REPORTED THE COIL WAS DEPLOYED INSIDE THE ANEURYSM. DURING DELIVERY OF THE SECOND COIL, THE PREVIOUS IMPLANTED COIL CAME OUT OF THE ANEURYSM AND FLOWED DISTALLY TO THE ACA. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE COIL, BUT WITHOUT SUCCESS. IT WAS REPORTED THE PT HAD SURGICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIUM HELIX DETACHABLE COIL | DETACHED COIL | HCG | EV3 NEUROVASCULAR | QC-1.5-2-HELIX | 9046212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention| S |