FDA Adverse Event
Injury
Summary report: N
ONYX, AVM
MDR report key: 4111656
·
Received September 23, 2014
Report
- Report Number
- 2029214-2014-00551
- Event Type
- Injury
- Date Received
- September 23, 2014
- Date of Event
- August 29, 2014
- Report Date
- September 18, 2014
- Manufacturer
- IRVINE
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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).
Additional Manufacturer Narrative · 1
THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS: MODEL: 105-7000-065 / LOT: 9900380 DOM: 21 APR 2014 EXP: 03 NOV 2016. MODEL: 105-7000-065 / LOT: 9907188 DOM: 05 MAY 2014 EXP: 03 NOV 2016. MODEL: 105-7000-060 / LOT: 9926581 DOM: 13 JUN 2014 EXP: 30 MAR 2017. (B)(4).
Description of Event or Problem · 1
INFORMATION RECEIVED FROM THE ONYX DAVF (DURAL ARTERIOVENOUS FISTULA) PROSPECTIVE REGISTRY: SUBJECT (B)(6). THE PATIENT UNDERWENT ONYX EMBOLIZATION TREATMENT. ON (B)(6) 2014, IT WAS REPORTED THE PATIENT HAD SEVERE HEADACHE AND OCCLUSION OF THE DRAINING VEIN. THE PATIENT WAS PLACED ON TRAMADOL, PARACETAMOL, AND LOVENOX FOR 10 DAYS. NO SERIOUS INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 592443 | ONYX, AVM | LIQUID EMBOLIC | MFE | IRVINE | 105-7000-065 | 9853999 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |