BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON

    MDR report key: 6448583 · Received March 30, 2017

    Report

    Report Number
    2029214-2017-00294
    Event Type
    Injury
    Date Received
    March 30, 2017
    Date of Event
    January 1, 2009
    Report Date
    November 16, 2016
    Manufacturer
    MEDTRONIC COVIDIEN
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GAO KUN, YANG XIN-JIAN, MU SHI-QING, ET AL. "EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS WITH ETHYLENE VINYL ALCOHOL COPOLYMER: TECHNICAL ASPECTS. CHINESE MEDICAL JOURNAL 2009;122(16):1851-1856. THE DEVICE WAS NOT RETURNED FOR EVALUATION; WITHOUT RETURN OF THE DEVICE, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. MDRS RELATED TO THIS REPORT: 2029214-2017-00292 2029214-2017-00293 2029214-2017-00294. 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 REVIEW OF LITERATURE THAT DURING ONYX EMBOLIZATION A MICROCATHETER WAS GLUED IN THE AVM OF 5 PATIENTS AND CUT OFF IN THE GROIN BECAUSE OF THE LONG INJECTION TIME AND REFLUX LENGTH. OF THESE FIVE PATIENTS, THREE EXHIBITED NO NEW NEUROLOGICAL DEFICIT, ONE PATIENT WITH TRANSIENT DIPLOPIA, AND ANOTHER PATIENT WITH TRANSIENT RIGHT HEMIPARESIS. DMSO COMPATIBLE CATHETERS WERE USED (ULTRAFLOW AND MARATHON) HOWEVER THE MODELS OF THE CATHETERS THAT WERE GLUED TO THE AVM WERE NOT PROVIDED. THIS COHORT WAS FROM SEPTEMBER 2003 TO NOVEMBER 2007, 115 PATIENTS (43 WOMEN AND 72 MEN, WITH A MEAN AGE OF 29 YEARS) WITH BAVMS WERE ENDOVASCULARLY TREATED WITH ONYX IN OUR DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227284 MARATHON CATHETER, CONTINUOUS FLUSH KRA MEDTRONIC COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Disability