BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX

    MDR report key: 10980830 · Received December 9, 2020

    Report

    Report Number
    2029214-2020-01277
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    October 26, 2020
    Report Date
    December 9, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE RELATED REGULATORY REPORTS 2029214-2020-01275 AND 2029214-2020-01276. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MENGES, A.-L., TRENNER, M., RADU, O., BEDDOE, D., KALLMAYER, M., ZIMMERMANN, A., & ECKSTEIN, H.-H. (2020). LACK OF DURABILITY AFTER TRANSARTERIAL ETHYLENE-VINYL ALCOHOL COPOLYMER-EMBOLIZATION OF TYPE II ENDOLEAK FOLLOWING ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. VASA. ZEITSCHRIFT FUR GEFASSKRANKHEITEN, 49(6), 483-491. HTTPS://DOI.ORG/10.1024/0301-1526/A000905 MEDTRONIC RECEIVED A LITERATURE ARTICLE PERTAINING TO PATIENTS TREATED WITH ONYX FOR A TYPE II ENDOLEAK. IN THIS ARTICLE THE AVERAGE AGE OF THE PATIENTS WAS 77.8 YEARS, A MAJORITY MALE. IN ONE PATIENT THE ONYX DISLOCATED AND LARGE PARTS EMBOLIZED LARGE PARTS INTO THE IMA, RESULTING IN SEVERE INTESTINAL ISCHEMIA. CONSEQUENTLY, AN EMERGENCY OPERATION WITH SIGMOID RESECTION AND HARTMAN'S PROCEDURE WAS PERFORMED FOLLOWED BY SEVERAL OPERATIONS BECAUSE OF OPEN ABDOMEN PROCEDURE. AN EXTENDED STAY ON INTENSIVE CARE UNIT WAS NECESSARY. THE PATIENT WAS DISCHARGED AFTER 43 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438557 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR