BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC

    MDR report key: 211957 · Received February 25, 1999

    Report

    Report Number
    211957
    Event Type
    Death
    Date Received
    February 25, 1999
    Date of Event
    January 21, 1999
    Report Date
    February 19, 1999
    Manufacturer
    MEDTRONIC
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 52 YEAR OLD MALE IN HOSPITAL FOR ATTEMPTED EMBOLIZATION. A COMPLIANT BALLOON WAS ADVANCED THROUGH THE VERTEBRAL ARTERY SUCH THAT IT LAY AT THE BASILAR TIP. THE BALLOON WAS INFLATED AND SPONTANEOUSLY RUPTURED. BALLOON WITHDRAWN FOR INSPECTION. WITHIN ONE MINUTE, PT EXPERIENCED ACUTE RISE IN BLOOD PRESSURE AND HEART RATE. REPEAT ARTERIOGRAM DEMONSTRATED NEAR-COMPLETE CIRCULATORY ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC Implant BALLOON - PTA BALLOON LIT MEDTRONIC SOLSTICE SYSTEM *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death 2MM X 2CM GDC COIL| 5 FRENCH CATHETER