BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6269850 · Received January 23, 2017

    Report

    Report Number
    2029214-2017-00062
    Event Type
    Injury
    Date Received
    January 23, 2017
    Date of Event
    October 2, 2013
    Report Date
    February 2, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SEYED AMELI-RENANI,MBBS,FRCRN, AND R.A.MORGAN,MBCHB,MRCP,FRCR ,EBIR. SECONDARY INTERVENTIONS AFTER ENDOVASCULAR ANEURYSM SAC SEALING: ENDOLEAK EMBOLIZATION AND LIMB-RELATED INTERVENTIONS. SEMINARS IN VASCULAR SURGERY 29(2016)61¿67. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AS IT WAS FULLY USED IN THE PROCEDURE. THE ONYX MODEL AND LOT NUMBER WERE NOT PROVIDED. THERE IS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER NO RESPONSE HAS BEEN RECEIVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING PATIENT CONDITION. SHOULD IT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BASED ON THE REPORTED INFORMATION FROM THE LITERATURE REVIEW, THERE IS NO EVIDENCE SUGGESTING THAT THE ONYX WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. DEVICE MIGRATION AND CAST MOVEMENT ARE LISTED IN THE POTENTIAL COMPLICATIONS IN THE ONYX INSTRUCTIONS FOR USE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT DURING A CASE TO TREAT A PROXIMAL ENDOLEAK POST ENDOVASCULAR ANEURYSM SEALING (EVAS) PROCEDURE, THE ONYX MIGRATED INTO THE EVAS GRAFT, CAUSING STENOSIS IN THE GRAFT. THIS WAS SUCCESSFULLY TREATED BY PLACING A COVERED STENT WITHIN THE LIMB OF THE GRAFT, AFFIXING THE ONYX BETWEEN THE STENT AND INSIDE WALL OF THE GRAFT, WHICH RESTORED PATENCY.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT DURING A CASE TO TREAT A PROXIMAL ENDOLEAK POST ENDOVASCULAR ANEURYSM SEALING PROCEDURE, THE ONYX MIGRATED INTO THE EVAS GRAFT, CAUSING STENOSIS IN THE GRAFT. THE ENDOLEAK OCCURRED 2 MONTHS POST PROCEDURE. THIS WAS SUCCESSFULLY TREATED BY PLACING A COVERED STENT WITHIN THE LIMB OF THE GRAFT, AFFIXING THE ONYX BETWEEN THE STENT AND INSIDE WALL OF THE GRAFT, WHICH RESTORED PATENCY. THE INJECTION RATE WAS NOT IN ACCORDANCE WITH THE IFU AT .30ML PER MINUTE TO TREAT THE ENDOLEAK AND THE PHYSICIAN PAUSED DURING INJECTION. THE PATIENT IS CURRENTLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52762 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention