FDA Adverse Event
Malfunction
Summary report: N
ONYX, AVM
MDR report key: 3910599
·
Received July 2, 2014
Report
- Report Number
- 2029214-2014-00377
- Event Type
- Malfunction
- Date Received
- July 2, 2014
- Date of Event
- June 5, 2014
- Report Date
- June 5, 2014
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- MFE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BEEN RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT.(B)(4).
Description of Event or Problem · 1
TREATMENT OF AN AVM (ARTERIOVENOUS MALFORMATION). ON (B)(6) 2014, THE PATIENT UNDERWENT ONYX EMBOLIZATION TREATMENT. IT WAS REPORTED DURING ONYX INJECTION, RESISTANCE WAS ENCOUNTERED AND THE CATHETER WAS REMOVED FROM THE PATIENT. ON THE BACK TABLE, THE CATHETER WAS TESTED WITH HIGH PRESSURE AND IT WAS FOUND TO BE LEAKING AT THE FLEXIBLE DISTAL SECTION. A NEW ULTRAFLOW CATHETER WAS USED WITH THE SAME GUIDEWIRE AND ONYX TO COMPLETE THE PROCEDURE.NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.SAME EVENT AS MDR# 2029214-2014-00376.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 388202 | ONYX, AVM | LIQUID EMBOLIC | MFE | EV3 NEUROVASCULAR | 105-7000-060 | 9876614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 YR |