FDA Adverse Event
Injury
Summary report: N
AXIUM 3-D DETACHABLE COIL
MDR report key: 1060635
·
Received June 13, 2008
Report
- Report Number
- 2029214-2008-00108
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- May 14, 2008
- Report Date
- May 15, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THIS EVENT HAS BEEN RETURNED AND IS BEING EVALUATED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. SEE SCANNED PAGE.
Description of Event or Problem · 1
COILING TREATMENT OF A BASILAR TIP ANEURYSM. IT WAS REPORTED THE COIL DETACHED INSIDE THE CATHETER DURING REPOSITIONING. THE PHYSICIAN WAS ABLE TO PUSH THE COIL INTO THE ANEURYSM WITH A SMALL COIL TAIL PROTRUDING INTO THE PARENT ARTERY. NO PT 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-4-12-3D | 4967314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Disability |