FDA Adverse Event
Injury
Summary report: N
ONYX, AVM
MDR report key: 2222687
·
Received August 25, 2011
Report
- Report Number
- 2029214-2011-00224
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- June 20, 2011
- Report Date
- July 26, 2011
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT.(B)(4)
Description of Event or Problem · 1
TREATMENT OF AN AVM. IT WAS REPORTED THE CATHETER LEAKED DURING ONYX INJECTION. UPON REMOVAL, THE CATHETER BROKE OFF AND THE BROKEN SEGMENT REMAINED IN THE PATIENT. IT WAS REPORTED THE PATIENT EXPERIENCED AN EMBOLIC STROKE. SAME EVENT AS MDR# 2029214-2011-00223.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONYX, AVM | LIQUID EMBOLIC | MFE | EV3 NEUROVASCULAR | NOT REPORTED | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |