BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4874946

    MDR report key: 4874946 · Received June 26, 2015

    Report

    Report Number
    4874946
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 15, 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

    ON (B)(6) 2015 DURING CORONARY INTERVENTION A DRUG-ELUTING RESOLUTE STENT 2.25 X 30 MM WAS DEPLOYED. UPON REVIEW OF THE INTRAVASCULAR ULTRASOUND (IVUS) THE STENT WAS NOT VISUALIZED IN THE INTENDED SEGMENT BUT WAS NOTED TO BE WITHIN A MORE PROXIMAL STENT IN THE MID PORTION OF THE LAD. THE PATIENT RETURNED TO THE CATH LAB ON (B)(6) 2015 WHERE A BARE METAL STENT WAS SUCCESSFULLY PLACED.

    Patients

    Seq Age Sex Outcome Treatment
    1