BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4874954

    MDR report key: 4874954 · Received June 26, 2015

    Report

    Report Number
    4874954
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 25, 2015
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PCI, PHYSICIAN WAS ATTEMPTING TO PLACE BARE METAL STENT. WHILE REMOVING THE UNDEPLOYED STENT THE STENT CAME OFF THE BALLOON IN AN UNINTENDED ARTERY. PHYSICIAN INSERTED A SECOND BALLOON THROUGH THE UNDEPLOYED STENT AND WAS ABLE TO SUCCESSFULLY DEPLOY THE STENT IN THE INTENDED CORONARY ARTERY. A 2.5 X 14 MM INTEGRITY STENT.

    Patients

    Seq Age Sex Outcome Treatment
    1