BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIRE

    MDR report key: 466163 · Received June 12, 2003

    Report

    Report Number
    2954759-2003-00004
    Event Type
    Malfunction
    Date Received
    June 12, 2003
    Date of Event
    May 12, 2003
    Report Date
    June 12, 2003
    Manufacturer
    VASCULAR ARCHITECTS
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DUPLEX DOPPLER REVEALED BILATERAL RESTENOSIS AND FRACTURED STENTS IN LEFT PROXIMAL SFA, LEFT DISTAL PROXIMAL SFA, LEFT DISTAL SFA AND RIGHT PROXIMAL SFA. THE VESSELS WERE SUCCESSFULLY REDILATED AND PATENCY WAS REESTABLISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPIRE ASPRIE STENT - PERIPHERAL NIP VASCULAR ARCHITECTS L80-70-050 0823021

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR