FDA Adverse Event
Injury
Summary report: N
AXIUM PGLA 3-D DETACHABLE COIL
MDR report key: 1936079
·
Received December 13, 2010
Report
- Report Number
- 2029214-2010-00263
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- September 21, 2010
- Report Date
- November 17, 2010
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES WILL NOT BE RETURNED FOR EVAL AS THEY WERE IMPLANTED IN THE PT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED POST PROCEDURE, THE PT HAS IMAGES WITH SPOTS OF SWELLING AND ENHANCEMENT IN THE BRAIN. NO OTHER COMPLICATIONS WERE REPORTED WITH THE PT. SAME EVENT AS MDR# 2029214-2010-00262.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIUM PGLA 3-D DETACHABLE COIL | DETACHABLE COIL | HCG | EV3 NEUROVASCULAR | PC-9-20-3D | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Disability | OTHER COILS INVOLVED:| MODEL #: PC-4-12-HELIX, LOT# NOT REPORTED| MODEL #: PC-5-15-HELIX, LOT# NOT REPORTED |