FDA Adverse Event
Injury
Summary report: N
ONYX AVM
MDR report key: 1984149
·
Received February 10, 2011
Report
- Report Number
- 2029214-2011-00028
- Event Type
- Injury
- Date Received
- February 10, 2011
- Date of Event
- December 23, 2010
- Report Date
- January 12, 2011
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT.(B)(4)
Description of Event or Problem · 1
EMBOLIZATION TREATMENT OF AN AVM. IT WAS REPORTED THE CATHETER RUPTURED DURING ONYX INJECTION AND ONYX WAS OBSERVED IN THE FEEDING VESSEL TO THE AVM. NO PATIENT INJURY REPORTED. SAME EVENT AS MDR# 2029214-2011-00027.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONYX AVM | LIQUID EMBOLIC | MFE | EV3 NEUROVASCULAR | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |