FDA Adverse Event
Malfunction
Summary report: N
ONYX, AVM
MDR report key: 1013978
·
Received March 11, 2008
Report
- Report Number
- 2029214-2008-00039
- Event Type
- Malfunction
- Date Received
- March 11, 2008
- Date of Event
- February 13, 2008
- Report Date
- February 13, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- MFE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EMPTY VIAL OF ONYX WAS RETURNED FOR EVALUATION. THEREFORE, RADIO-OPACITY TESTING WAS PERFORMED ON THE RETAINED SAMPLE FROM THE SAMPLE LOT AND WAS FOUND TO BE WITHIN SPECIFICATION.
Description of Event or Problem · 1
TREATMENT OF AN AVM. IT WAS REPORTED ONYX COULD NOT BE FULLY VISUALIZED UNDER FLUOROSCOPY DURING THE PROCEDURE. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONYX, AVM | LIQUID EMBOLIC | MFE | EV3 NEUROVASCULAR | 105-7000-065 | 4460940 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |