FDA Adverse Event
Injury
Summary report: N
ONYX, AVM
MDR report key: 1013321
·
Received March 12, 2008
Report
- Report Number
- 2029214-2008-00040
- Event Type
- Injury
- Date Received
- March 12, 2008
- Date of Event
- February 11, 2008
- Report Date
- February 15, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE VIAL OF ONYX WAS RETURNED FOR EVALUATION, BUT DID NOT CONTAIN ENOUGH OF THE EMBOLIC SOLUTION TO PERFORM TESTING. RADIO-OPACITY TEST WAS PERFORMED ON THE RETAINED SAMPLE FROM THE SAME 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 VISUALIZED EXITING THE CATHETER'S TIP DURING PROCEDURE. AN ANGIOGRAM WAS PERFORMED AND THE AVM VESSELS WERE NO LONGER FILLABLE. THE PHYSICIAN WAS UNSURE IF THIS WAS CAUSED BY VESSEL VASOSPASM OR THE VESSELS WERE EMBOLIZED WITH ONYX. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONYX, AVM | LIQUID EMBOLIC | MFE | EV3 NEUROVASCULAR | 105-7100-080 | 4714122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Disability |