FDA Adverse Event
Injury
Summary report: N
ONYX AVM
MDR report key: 4233486
·
Received November 6, 2014
Report
- Report Number
- 2029214-2014-00629
- Event Type
- Injury
- Date Received
- November 6, 2014
- Date of Event
- October 6, 2014
- Report Date
- October 10, 2014
- Manufacturer
- COVIDIEN
- 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 AS IT WAS CONSUMED IN THE EVENT. (B)(4).
Description of Event or Problem · 1
INFORMATION RECEIVED FROM THE ONYX CAVM (CEREBRAL ARTERIOVENOUS MALFORMATION) STUDY, SUBJECT #0402. TREATMENT OF A CAVM. ON (B)(6) 2014, THE PATIENT UNDERWENT ONYX EMBOLIZATION. DURING THE PROCEDURE, IT WAS REPORTED THERE WAS AN SAH (SUBARACHNOID HEMORRHAGE) THAT WAS NOT RELATED TO THE ONYX, BUT PROCEDURE RELATED. THE SAH WAS BENIGN AND THE PHYSICIAN BELIEVES THAT THE SAH WAS CAUSED BY A BREAK IN THE ARTERY DURING ACCESS. POST PROCEDURAL MRI (MAGNETIC RESONANCE IMAGING) SHOWED AN EDEMA, BUT THERE WAS NO HEMORRHAGE OR INFARCTION. THERE WAS NOT TREATMENT PROVIDED FOR THE SAH. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712839 | ONYX AVM | LIQUID EMBOLIC | MFE | COVIDIEN | 105-7000-060 | 9892020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Disability |