BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIRE STENT

    MDR report key: 450397 · Received March 18, 2003

    Report

    Report Number
    2954759-2003-00001
    Event Type
    Malfunction
    Date Received
    March 18, 2003
    Date of Event
    February 18, 2003
    Report Date
    March 18, 2003
    Manufacturer
    VASCULAR ARCHITECTS
    Product Code
    MEW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ANGIOGRAPHY OF LEFT LEG REVEALED A RESTENOSIS OF THE POPLITEAL ARTERY AND A FRACTURED STENT. THE VESSEL WAS SUCCESSFULLY REDILATED AND STENTED AGAIN. PATENCY WAS REESTABLISHED. PATIENT TOLLERATED PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPIRE STENT STENT MEW VASCULAR ARCHITECTS S80-07-100 0321021

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention