BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURANT BALLOON EXPANDABLE STENT SYSTEM

    MDR report key: 5074067 · Received September 14, 2015

    Report

    Report Number
    5074067
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 25, 2015
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN ATTEMPT TO PLACE KISSING STENTS TO THE ILIAC, FLUORO WAS SHOT AND UPON REVIEW, IT APPEARED THERE WAS NOT A STENT DEPLOYED ON THE LEFT SIDE. THE ASSURANT COBALT PERIPHERAL STENT WAS REMOVED FROM THE BODY AND IT WAS DETERMINED THE STENT WAS NOT ON THE BALLOON. THE STAFF FELT IT HAD POSSIBLY BEEN DAMAGED IN THE PACKAGING AND HAD FALLEN TO THE GROUND UPON REMOVING. THE UNDEPLOYED STENT WAS FOUND ON THE FLOOR DURING CLEAN UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606262 ASSURANT BALLOON EXPANDABLE STENT SYSTEM ASSURANT BALLOON-EXPANDABLE STENT SYSTEM DQY MEDTRONIC VASCULAR 6F 30MM 80CM 0007030923

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR