BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX LES

    MDR report key: 6517595 · Received April 24, 2017

    Report

    Report Number
    2029214-2017-00524
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    December 21, 2012
    Report Date
    March 30, 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

    CITATION: FENG WENFENG, ZHANG LONG, LI WEIGUANG, ZHANG GUOZHONG, HE XIAOYAN, WANG GANG, LI MINGZHOU, QI SONGTAO. A NEW METHOD FOR DISTANT ONYX INJECTION FOR TREATMENT OF INTRACRANIAL ARTERIOVENOUS MALFORMATIONS: REPORT OF 26 CASES. J SOUTH MED UNIV, 2013, 33(4). THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE FEASIBILITY, EFFICACY AND SAFETY OF DISTANT INJECTION OF ONYX TO TREAT INTRACRANIAL AVMS. THE AUTHORS CONCLUDED THAT ENDOVASCULAR TREATMENT OF INTRACRANIAL AVMS WITH ONYX EMBOLIZATION USING THE NEW DISTANT INJECTION METHOD IS FEASIBLE, SAFE AND EFFECTIVE. IT MINIMIZES POTENTIAL RADIATION EXPOSURE OF THE SURGEONS WITHOUT INCREASING THE RISKS OF RELATED COMPLICATIONS. THE PRODUCTS WERE NOT RETURNED FOR EVALUATION AS THESE EVENTS WERE REPORTED THROUGH LITERATURE REVIEW. THERE IS LIMITED PATIENT, PROCEDURE AND DEVICE INFORMATION AVAILABLE WITHIN THE ABSTRACT ARTICLE, AND THERE WAS NO CONFIRMED DEFECT OR DEVICE DEFICIENCY. BASED ON THE LIMITED REPORTED INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED EVENT IS PROCEDURE RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON THIS REPORTED EVENT. SHOULD IT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MDRS FROM THIS LITERATURE REVIEW: 2029214-2017-00524 AND 2029214-2017-00525. 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT ONYX LEAKAGE OCCURRED DURING THE PROCEDURE, RESULTING FROM A BROKEN MARATHON MICROCATHETER. THE PATIENT DEVELOPED HEMIPARESIS AFTER THE PROCEDURE. THE PATIENT WAS RECEIVING THE ONYX EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298767 ONYX LES AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability