BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS

    MDR report key: 1951149 · Received December 30, 2010

    Report

    Report Number
    MW5018856
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    June 3, 2010
    Report Date
    December 30, 2010
    Manufacturer
    PROMUS
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE PHYSICIAN ADVANCED PROMUS 3.0 DES AND STENT CAME OFF WIRE WITHOUT DEPLOYING. PHYSICIAN HAD TO RETRIEVE STENT. DATE OF USE: (B)(6) 2010, ONE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ PROMUS PROMUS 3.0 9032341

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR