FDA Adverse Event
Injury
Summary report: N
ONYX, AVM
MDR report key: 3910882
·
Received July 2, 2014
Report
- Report Number
- 2029214-2014-00387
- Event Type
- Injury
- Date Received
- July 2, 2014
- Date of Event
- June 5, 2014
- Report Date
- June 6, 2014
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
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
EMBOLIZATION OF AN ANTERIOR COMMUNICATING BRANCH WITH PROXIMAL VESSEL CLOSURE OF LEFT PERICALLOSAL ARTERY. ON (B)(6) 2014, THE PATIENT UNDERWENT ONYX EMBOLIZATION TREATMENT. DURING THE ONYX INJECTION, THE MARATHON CATHETER RUPTURED AT APPROXIMATELY 7CM FROM THE DISTAL TIP. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.SAME EVENT AS MDR# 2029214-2014-00386.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 387308 | ONYX, AVM | LIQUID EMBOLIC | MFE | EV3 NEUROVASCULAR | NOT REPORTED | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |