BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIRE

    MDR report key: 617057 · Received August 5, 2004

    Report

    Report Number
    2954759-2004-00014
    Event Type
    Malfunction
    Date Received
    August 5, 2004
    Date of Event
    March 22, 2004
    Report Date
    August 4, 2004
    Manufacturer
    VASCULAR ARCHITECTS
    Product Code
    MEW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TEH SITE REPORTED UPON FLAT PLATE X-RAY A STENT FRACTURE WAS FOUND IN THE LEFT DISTAL SFA. NO TREATMENT WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPIRE STENT MEW VASCULAR ARCHITECTS L80-06-050 0204031

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other