BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6571363 · Received May 16, 2017

    Report

    Report Number
    2029214-2017-00657
    Event Type
    Injury
    Date Received
    May 16, 2017
    Date of Event
    March 5, 2015
    Report Date
    April 18, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LI, C. (2015). CRANIAL NERVE DYSFUNCTION ASSOCIATED WITH CAVERNOUS DURAL ARTERIOVENOUS FISTULAS AFTER TRANSVENOUS EMBOLIZATION WITH ONYX. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 38(5), 1162-1170. DOI:10.1007/S00270-015-1062-Y THE ONYX USED ON THESE PATIENTS WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IN THE PATIENT; PRODUCT ANALYSIS CANNOT BE PERFORMED. FROM THE PROVIDED INFORMATION, THE REPORTED EVENTS COULD NOT BE CONFIRMED. THE PROVIDED INFORMATION DOES NOT SUGGEST ANY DEFECT OF THE ONYX; THE EVENTS ARE MORE LIKELY TO BE PROCEDURE-RELATED.

    Description of Event or Problem · 1

    MEDTRONIC LITERATURE REVIEW FOUND REPORTS OF NEW OR WORSENED CRANIAL NERVE DYSFUNCTION (CND) AFTER ONYX TRANSVENOUS EMBOLIZATION (TVE) OF CRANIAL DURAL ARTERIOVENOUS FISTULAS (CDAVFS). THE AUTHORS REVIEWED 41 PATIENTS WITH 45 CDAVFS TREATED WITH TVE; 17 WERE MEN AND 24 WERE WOMEN, MEAN AGE WAS 51.0 YEARS. THE ARTICLE STATES THAT TVE-RELATED COMPLICATIONS INCLUDED TRANSIENT BRADYCARDIA DURING THE ONYX INJECTIONS IN 3 CASES AND AGGRAVATED OR NEW CNDS IN 14 CASES. NO OTHER PROCEDURE RELATED COMPLICATIONS WERE OBSERVED. THE ARTICLE ALSO STATES THAT ONE PAGE (PATIENT #27, FEMALE, AGE (B)(6)) DEVELOPED NEW CRANIAL NERVE VI PALSY AFTER TVE AND DID NOT HAVE FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352143 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other