BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A SPIRE

    MDR report key: 523610 · Received February 13, 2004

    Report

    Report Number
    2954759-2004-00003
    Event Type
    Malfunction
    Date Received
    February 13, 2004
    Date of Event
    January 16, 2004
    Report Date
    February 13, 2004
    Manufacturer
    VASCULAR ARCHITECTS, INC.
    Product Code
    JCT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR REPORTED THAT SIX PTS HAD RETENOSIS AND STENT FRACTURE/MALFORMATION. PLEASE REFER TO ATTACHED LIST. EVENT: RESTENOSIS & FRACTURE OF PROXIMAL RIGHT SFA STENT. TREATED WITH MEDICAL MANAGEMENT. RESTENOSIS & FRACTURE OF PROXIMAL & MID LEFT SFA STENTS. TREATED SUCCESSFULLY WITH BYPASS. RESTENOSIS & FRACTURE OF DISTAL RIGH SFA STENT. TREATED SUCCESSFULLY WITH PTA. RESTENOSIS & FRACTURE OF MID LEFT SFA STENT. TREATED SUCCESSFULLY WITH PTA. RESTENOSIS & FRACTURE OF MID RIGHT SFA STENT. TREATMENT IS PENDING. RESTENOSIS & MALFORMATION OF MID RIGHT SFA STENT. TREATED SUCCESSFULLY WITH PTA/STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A SPIRE STENT JCT VASCULAR ARCHITECTS, INC. SEE LIST SEE LIST

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention