BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESTENT NT SELF EXPANDING BILIARY STENT AND DELIVERY SYSTE

    MDR report key: 694726 · Received March 29, 2006

    Report

    Report Number
    6000002-2006-00183
    Event Type
    Other
    Date Received
    March 29, 2006
    Date of Event
    February 15, 2006
    Report Date
    February 27, 2006
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY THIS PT ORIGINALLY PRESENTED WITH AN OCCLUSION OF THE DISTAL SFA IN JULY 2005. FOLLOWING A FAILED ANGIOPLASTY PROCEDURE, IT WAS INDICATED THAT A STENT WAS IMPLANTED IN THE LEFT SFA. 6.5 MONTHS LATER, PT WAS SYMPTOMATIC. ULTRASOUND IDENTIFIED A RE-OCCLUDED REGION. ANGIOGRAM CONFIRMED STENOSIS AND INTERVENTION (PTA) WAS SUCCESSFUL AND IMPROVED FLOW. UNDER ANGIOGRAPHY THE STENT WAS NOTED TO HAVE FRACTURED WITH A GAP BETWEEN THE SEGMENTS ANALYSIS OF THE RE-INTERVENTION FILMS IDENTIFIED THAT THE STENT WAS ELONGATED DURING THE INITIAL DEPLOYMENT IN JULY 2005. ADDITIONALLY, THERE WAS SOME DEFORMATION OF THE PROXIMAL SEGMENT OF THE IMPLANT. THE PT IS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT NT SELF EXPANDING BILIARY STENT AND DELIVERY SYSTE BILIARY STENT FGE EDWARDS LIFESCIENCES NT356802 SE5B0990

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention