BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT PERIPHERAL STENT

    MDR report key: 1141639 · Received August 28, 2008

    Report

    Report Number
    MW5008119
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    December 3, 2007
    Report Date
    August 28, 2008
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RECENT NOTIFICATION OF THIS EVENT. PT WAS UNDERGOING BILATERAL LEG ANGIOGRAM AND STENT PLACEMENT. THE "END FLUSH PIECE" OF THE BALLOON BROKE OFF AND PARTIALLY DEPLOYED ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT PERIPHERAL STENT XCEED PERIPHERAL STENT NIP ABBOTT VASCULAR 50050-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability