BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYPERGLIDE OCCLUSION BALLOON SYSTEM

    MDR report key: 448454 · Received March 18, 2003

    Report

    Report Number
    2029214-2003-00009
    Event Type
    Death
    Date Received
    March 18, 2003
    Date of Event
    February 11, 2003
    Report Date
    February 19, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    MJN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE WAS FOR TREATMENT OF 3 BRAIN ANEURYSMS. UPON BALLOON INFLATION, VESSEL RUPTURED, CAUSING SEVERE HEMORRHAGING AND SUBSEQUENT DEATH. POST-OP AUTOPSY REVEALED PT'S VESSLS WERE DYSPLASTIC. DR FELT BALLOON PERFORMED NORMALLY AND AS ANTICIPATED. THE VESSEL DIAMETER MAY HAVE BEEN LESS THAN THE DIAMETER OF THE INFLATED BALLOON. A KEY FACTOR IN THE EVENT WAS THE PRE-EXISTING VESSEL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERGLIDE OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON MJN MICRO THERAPEUTICS, INC. 104-4112 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death