BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS DES 2.5 X 23 STENT

    MDR report key: 1980185 · Received January 31, 2011

    Report

    Report Number
    MW5019266
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 31, 2011
    Manufacturer
    PROMUS DES/ BCS
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PCI INTERVENTION ON (B)(6) 2011; STENT CAME OFF BALLOON (WOULD NOT PASS OR RETURN), THEN EXPANDED WITH 2.5 X 2.0 BALLOON FOR 30 SECONDS. PROCEDURE COMPLETED. PT STABLE AND TRANSFERRED TO ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS DES 2.5 X 23 STENT 2.5 X 23 STENT NIQ PROMUS DES/ BCS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability