BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 4789575 · Received May 21, 2015

    Report

    Report Number
    2029214-2015-00579
    Event Type
    Injury
    Date Received
    May 21, 2015
    Date of Event
    January 22, 2012
    Report Date
    April 22, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/22270731. THE ONYX WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT REPORTED. (B)(4).

    Description of Event or Problem · 1

    CITATION: MURAT CANTASDEMIR, ET AL. THE USE OF ONYX FOR EMBOLIZATION OF PERIPHERAL VASCULAR MALFORMATIONS IN PEDIATRIC PATIENTS. PEDIATR SURG INT (2012) 28:477-487. DOI 10.1007/S00383-012-3052-3. PUBLISHED ONLINE: 22 JANUARY 2012. THE FOLLOWING REPORT WAS RECEIVED BY MEDTRONIC (COVIDIEN) THROUGH LITERATURE REVIEW: IN ONE PATIENT, REFLUX TO THE ANTERIOR AND POSTERIOR TIBIAL ARTERIES CAUSED PERIPHERAL ISCHEMIA, AND WORSENING OF SKIN CONDITION AS A RESULT OF OCCLUSION OF THESE ARTERIES. WHICH WAS NOTED TO BE LIKELY AS A RESULT OF NONTARGET EMBOLIZATION, DESPITE SIGNIFICANTLY REDUCED FLOW THROUGH THE LESION. PATIENT WAS REFERRED TO UNDERGO PLASTIC SURGERY AND TREATED WITH FREE LATISIMUS DORSI MUSCLE TRANSFER. THE LESION LOCATION WAS NOTED TO BE ON THE RIGHT CALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331059 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention