FDA Adverse Event
Injury
Summary report: N
ONYX, AVM
MDR report key: 2190935
·
Received August 4, 2011
Report
- Report Number
- 2029214-2011-00201
- Event Type
- Injury
- Date Received
- August 4, 2011
- Date of Event
- June 15, 2011
- Report Date
- July 7, 2011
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PE
- 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. IT WAS REPORTED THE CATHETER RUPTURED AT APPROXIMATELY 5CM FROM THE DISTAL TIP DURING ONYX INJECTION. AS A RESULT, ONYX WAS OBSERVED EXITED THROUGH THE RUPTURE SITE INTO OTHER VESSEL. NO PATIENT INJURY REPORTED. SAME EVENT AS MDR# 2029214-2011-00200.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONYX, AVM | LIQUID EMBOLIC | MFE | EV3 NEUROVASCULAR | 105-7000-060 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Disability |