BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON MICRO CATH

    MDR report key: 1621666 · Received February 23, 2010

    Report

    Report Number
    1621666
    Event Type
    Death
    Date Received
    February 23, 2010
    Date of Event
    February 13, 2010
    Report Date
    February 22, 2010
    Manufacturer
    EV3, INC.
    Product Code
    KRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DIAGNOSIS OF ANEURYSM OF INFERIOR VERMIAN BRANCH OF RT PICA AND ARTERIOVENOUS MALFORMATION (AVM) OF RT PICA WITH SUBARACHNOID HEMORRHAGE (SAH) ON (B) (6) 2010. DURING CEREBRAL EMBOLIZATION ON (B) (6) 2010, ONYX MATERIAL SEPARATED FROM REST OF GLUE CATHETER AND WAS ADHERENT TO DISTAL TIP OF CATHETER. THIS BECAME ADHERENT TO SUPERIOR CEREBELLAR ARTERY. UNABLE TO RETRIEVE CATHETER - REMAINS IMPLANTED. SUBSEQUENT RADIOLOGICAL TESTING NOTED MULTIPLE INFARCTS AND OCCLUSIONS. PATIENT UNRESPONSIVE, TESTING AND PHYSICIAN ASSESSMENTS CONCLUDED NO FUNCTIONAL QUALITY OF LIFE PREDICTED. FAMILY DECISION TO PROCEED WITH DONATION AFTER CARDIAC DEATH. PATIENT PRONOUNCED ON (B) (6) 2010 AT 1427.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON MICRO CATH ECHELON MICRO CATH KRA EV3, INC. 5602949

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death