BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 10980815 · Received December 9, 2020

    Report

    Report Number
    2029214-2020-01275
    Event Type
    Death
    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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE 30-DAY-MORTALITY AND MORTALITY DURING FOLLOW UP WAS 6.6% (1 PATIENT) AND 20.0% (3 PATIENTS). THE PATIENT WHO DEVELOPED POSTOPERATIVE MYOCARDIAL INFARCTION DIED 6 DAYS AFTER INTERVENTION. ONE PATIENT DIED WITHIN THE FIRST 12 MONTHS OF FOLLOW UP BECAUSE OF A SECONDARY AAA RUPTURE, PRESUMABLY DUE TO A RECURRENT EL. THE THIRD DEATH WAS NOT ASSOCIATED WITH THE AORTIC ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438518 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death