ONYX
Report
- Report Number
- 2029214-2017-00335
- Event Type
- Injury
- Date Received
- March 31, 2017
- Date of Event
- April 6, 2012
- Report Date
- November 16, 2016
- Manufacturer
- COVIDIEN (IRVINE)
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AS IT WAS CONSUMED IN THE PROCEDURE. ATTEMPTS HAVE BEEN MADE TO OBTAIN SPECIFIC INFORMATION, HOWEVER, OUR ATTEMPTS HAVE BEEN UNSUCCESSFUL. VARIOUS FUNCTIONAL NEUROLOGICAL DEFICITS (FACIAL NERVE PALSY) ARE A KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND ARE DOCUMENTED IN OUR DEVICE¿S INSTRUCTION FOR USE (IFU). BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE PRODUCT WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT AND ITS CAUSED WAS UNKNOWN. MDR RELATED TO THIS EVENT: 2029214-2017-00333 2029214-2017-00334 2029214-2017-00335 2029214-2017-00336 2029214-2017-00337 2029214-2017-00338 2029214-2017-00339 2029214-2017-00340 2029214-2017-00341.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CITATION: ONYX VERSUS N-BCA FOR EMBOLIZATION OF CRANIAL DURAL ARTERIOVENOUS FISTULAS. RABINOV JD1, YOO AJ, OGILVY CS, CARTER BS, HIR SCH JA. J NEUROINTERV SURG. 2013 JUL;5(4):306-10. DOI: 10.1136/NEURINTSURG-2011-010237. EPUB 2012 MAY 1. MEDTRONIC RECEIVED THE FOLLOWING REPORTS: PATIENT 29 (MALE, AGE RANGE 50-59) HAD A FACIAL NERVE PALSY FOLLOWING EMBOLIZATION OF THE POSTERIOR AURICULAR BRANCH OF HIS RIGHT EXTERNAL CAROTID ARTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233063 | ONYX | AGENT, INJECTABLE, EMBOLIC | MFE | COVIDIEN (IRVINE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |