BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 4893053 · Received July 6, 2015

    Report

    Report Number
    2029214-2015-00743
    Event Type
    Injury
    Date Received
    July 6, 2015
    Date of Event
    December 30, 2014
    Report Date
    June 8, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/25547081. THE ONYX WAS NOT RETURNED FOR ANALYSIS AS IT WAS CONSUMED IN THE EVENT; THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED, AND THE EVENT CAUSE COULD NOT BE DETERMINED. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE ONYX WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT REPORTED. REFERENCE: (B)(4).

    Description of Event or Problem · 1

    CITATION: S. AMELI-RENANI, ET AL. EMBOLISATION OF A PROXIMAL TYPE I ENDOLEAK POST-NELLIX AORTIC ANEURYSM REPAIR COMPLICATED BY REFLUX OF ONYX INTO THE NELLIX ENDOGRAFT LIMB. CARDIOVASC INTERVENT RADIOL (2015)38:747-751. DOI 10.1007/S00270-014-1044-5 THE FOLLOWING REPORT WAS RECEIVED BY MEDTRONIC (COVIDIEN) THROUGH REVIEW OF LITERATURE: THE ARTICLE DESCRIBED A TYPE 1 ENDOLEAK POST NELLIX ANEURYSM REPAIR IN A PATIENT. THE AUTHORS STATED THAT DURING THE INITIAL TREATMENT WITH ONYX, THEY OBSERVED A SMALL LINE OF ONYX MATERIAL DUE TO REFLUX; THE NELLIX LIMB WAS PATENT AND NO INTERVENTION WAS NECESSARY. HOWEVER, 6 WEEKS POST PROCEDURE, THERE WAS A SIGNIFICANT STENOSIS (75%) IN THE LEFT NELLIX LIMB CAUSED BY ONYX. THE ONYX MIGRATED AND SETTLED IN THE STENT IN A DEPENDENT FASHION. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH A STENT TO AFFIX THE ONYX BETWEEN THE STENT AND THE WALL OF THE NELLIX ENDOGRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435431 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other| R