BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 4841893 · Received June 12, 2015

    Report

    Report Number
    2029214-2015-00663
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    February 7, 2013
    Report Date
    May 14, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HTTP://WWW.AJNR.ORG/CONTENT/34/7/1395.FULL. THIS REPORT WAS CREATED TO CAPTURE THE SERIOUS INJURIES RELATED TO THE ONYX. THE ONYX WAS NOT RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENTS. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECTS OF THE DEVICES DURING USE. THE EVENTS OCCURRED IN THE PATIENTS POST PROCEDURE AND THEIR CAUSES WERE UNKNOWN. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT REPORTED. (B)(4). INFORMATION RECEIVED FROM THE SAME ARTICLE AS MFR: 2029214-2015-00662.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: INTEROPERATIVE RUPTURE WAS OBSERVED IN 2 PATIENTS, DURING CATHETERIZATION IN 1 PATIENT (IMMEDIATETLY TREATED WITH NBCA (GLUE INJECTION) AND AFTER ONYX INJECTION IN 1 PATIENT. (B)(4).

    Description of Event or Problem · 1

    CITATION: L. PIEROT, ET AL. COMBINED TREATMENT OF BRAIN AVMS WITH USE OF ONYX EMBOLIZATION FOLLOWED BY RADIOSURGERY. PUBLISHED ON LINE FEBRUARY 7, 2013. THE FOLLOWING REPORT WAS RECEIVED BY MEDTRONIC (COVIDIEN) THROUGH REVIEW OF LITERATURE: RESIDUAL NIDUS WAS DEPICTED AT 3 YEARS IN 3 PATIENTS AND 4 YEARS IN 4 PATIENTS. RESIDUAL NIDUS WAS TREATED BY ONYX EMBOLIZATION AND RADIOSURGERY IN 2 PATIENTS AND RADIOSURGERY ALONE IN 3 PATIENTS. IN 2 PATIENTS, ANOTHER CONTROL ANGIOGRAM WILL BE PERFORMED AFTER A YEAR. TWO PATIENTS HAD PARTIALLY REGRESSIVE DEFICIT AFTER 1 EMBOLIZATION SESSION. OF THESE, 1 HAD HEMIPARESIS WITH FAVORABLE EVOLUTION, AND 1 HAD HEMIPARESIS AND APHASIA WITH COMPLETE RECOVERY OF HEMIPARESIS BUT ONLY PARTIAL RECOVER OF APHASIA. THIS DEFICIT WAS THE RESULT OF A THROMBOEMBOLIC COMPLICATION. CLINICAL STATUS WAS PERMANENTLY WORSENED BY EMBOLIZATION IN 2 PATIENTS WITH MRS FINAL SCORE OF 1 IN 1 PATIENT AND 2 IN 1 PATIENT. POST TREATMENT MRS WAS 2 IN 2 PATIENTS, WITH AN INITIAL MRS SCORE OF 1 RELATED TO EMBOLIZATION COMPLICATIONS. OF THESE, 1 PATIENT SHOWED GOOD RECOVERY WITH FINAL MRS SCORE OF 1 AT THE FINAL CLINICAL EVALUATION. A TOTAL OF 20 PATIENTS (11 WOMEN AND 9 MEN); AGE RANGE, 10-55 YEARS WERE TREATED FOR BRAN AVM BY ONXY EMBOLIZATION FOLLOWED BY RADIOSURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386130 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R| S