FDA Adverse Event
Malfunction
Summary report: N
ONYX 20, AVM
MDR report key: 934970
·
Received April 11, 2007
Report
- Report Number
- 2029214-2007-00032
- Event Type
- Malfunction
- Date Received
- April 11, 2007
- Date of Event
- January 20, 2007
- Report Date
- March 15, 2007
- Manufacturer
- EV3 NEUROVASCULAR DIVISION
- Product Code
- MFE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
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 EVALUATION IS COMPLETED.
Description of Event or Problem · 1
DURING AVM TREATMENT, THE PHYSICIAN REPORTED TO HAVE OBSERVED LOW RADIOPACITY OF THE ONYX. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONYX 20, AVM | LIQUID EMBOLIC | MFE | EV3 NEUROVASCULAR DIVISION | * | 1829331 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |