FDA Adverse Event
Injury
Summary report: N
MARATHON MICRO CATHETER AND ONYX
MDR report key: 1556460
·
Received December 8, 2009
Report
- Report Number
- 2029214-2009-00323
- Event Type
- Injury
- Date Received
- December 8, 2009
- Date of Event
- August 3, 2009
- Report Date
- August 21, 2009
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- KRA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION. MODELS AND LOT# OF THE ONYX INVOLVED: MODEL# 105-7000-060, 105-7000-080. LOT# 7279662, 7201659. QTY 4 VIALS, 4 VIALS.
Description of Event or Problem · 1
TREATMENT OF AN AVM WITH ONYX. IT WAS REPORTED THE PHYSICIAN EMBOLIZED TWO FEEDERS OF THE AVM USING THREE MARATHON CATHETERS WITH APPROXIMATELY 1.94ML OF ONYX. POST PROCEDURE, SAH NOTICED VIA CT SCAN. NO COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARATHON MICRO CATHETER AND ONYX | FLOW-DIRECTED MICRO CATHETER AND LIQUID EMBOLIC | KRA | EV3 NEUROVASCULAR | 105-5055 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |