FDA Adverse Event
Injury
Summary report: N
ONYX AVM
MDR report key: 2132496
·
Received June 17, 2011
Report
- Report Number
- 2029214-2011-00149
- Event Type
- Injury
- Date Received
- June 17, 2011
- Date of Event
- May 18, 2011
- Report Date
- May 20, 2011
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
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 WITH ONYX. IT WAS REPORTED THAT THE CATHETER RUPTURED DURING ONYX INJECTION. UPON REMOVAL, THE CATHETER SEPARATED WITH THE DISTAL SEGMENT REMAINING IN THE PATIENT. IT WAS REPORTED THE PATIENT HAS A MINOR DEFICIT. SAME EVENT AS MDR# 2029214-2011-00148
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONYX AVM | LIQUID EMBOLIC | MFE | EV3 NEUROVASCULAR | 105-7000-060 | 9421989 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |