FDA Adverse Event
Injury
Summary report: N
ONYX AVM
MDR report key: 2120518
·
Received June 10, 2011
Report
- Report Number
- 2029214-2011-00142
- Event Type
- Injury
- Date Received
- June 10, 2011
- Date of Event
- May 2, 2011
- Report Date
- May 13, 2011
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES INVOLVED IN THE EVENT WILL NOT RETURNED FOR EVALUATION AS IT WAS CONSUMED I N THE EVENT. MODEL# AND LOT# OF OTHER ONYX INVOLVED:MODEL# LOT# 105-7100-080 UNKNOWN(B)(4)
Description of Event or Problem · 1
EMBOLIZATION TREATMENT OF AN AVM WITH ONYX. IT WAS REPORTED POST PROCEDURE, THE PATIENT EXPERIENCED LEFT HEMIPLEGIA. THE NEXT MORNING, INTRAVENTRICULAR HEMORRHAGE OCCURRED AND THE PATIENT REQUIRED VENTRICULAR DRAINAGE. AN ADDITIONAL EMBOLIZATION WAS PERFORMED ON (B)(6) AND HEMORRHAGE OCCURRED AGAIN THE NEXT MORNING. THE AVM WAS RESECTED AND NO OTHER COMPLICATIONS WERE REPORTED WITH THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONYX AVM | LIQUID EMBOLIC | MFE | EV3 NEUROVASCULAR | 105-7100-060 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S |