FDA Adverse Event
Injury
Summary report: N
AXIUM 3D DETACHABLE COIL
MDR report key: 1023369
·
Received April 2, 2008
Report
- Report Number
- 2029214-2008-00053
- Event Type
- Injury
- Date Received
- April 2, 2008
- Date of Event
- March 6, 2008
- Report Date
- March 6, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- 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 PT.
Description of Event or Problem · 1
COILING TREATMENT OF AN ANEURYSM. IT WAS REPORTED AFTER THE COIL WAS IMPLANTED, LOOP OF THE COIL WAS OBSERVED PROTRUDING INTO THE PARENT ARTERY. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIUM 3D DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | QC-4-8-3D | 4792863 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Disability |