BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1870823 · Received October 11, 2010

    Report

    Report Number
    3005325609-2010-00013
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    May 18, 2010
    Report Date
    September 28, 2010
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K071646
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE EVENT IS UNK. NO INDICATION OF A DEVICE MALFUNCTION. THE CAUSE IS LIKELY THE PT'S DISEASE PROGRESSION.

    Description of Event or Problem · 1

    THE PT IS CURRENTLY ENROLLED IN THE (B)(4) IN (B)(6). AT 7 MONTHS POST IMPLANT OF THE SUPERA STENT, A FOLLOW UP ANGIOGRAPHY SHOWED A NEW SIGNIFICANT STENOSIS OF THE PROXIMAL RIGHT SFA AS WELL AS AN IN-STENT RESTENOSIS MORE DISTALLY IN THE SUPERA STENT. THE PT HAD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE RIGHT SFA. THE RISK OF RESTENOSIS IS INCREASED IN PTS WITH DIABETES AND RENAL INSUFFICIENCY. THE PT ALSO DEVELOPED A CRITICAL IN-FLOW LESION TO THE ORIGINAL TARGET LESION. THE PTA WAS REPORTEDLY SUCCESSFUL WITH "VERY GOOD RESULT WITH SLIGHT DISSECTION DISTAL TO THE STENT WITH NO FLOW LIMITATION." THE CAUSE OF THE RESTENOSIS IS UNK; THERE IS NO INDICATION OF A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. SE-05-120-120-G2 00298038

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R