BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1930701 · Received December 14, 2010

    Report

    Report Number
    3005325609-2010-00018
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    May 18, 2010
    Report Date
    November 11, 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)(6). AT 7 MONTHS POST IMPLANT THE PT COMPLAINED OF PAIN IN THE RIGHT CALF. A DUPLEX SONOGRAM CONFIRMED STENOSIS OF THE RIGHT SUPERFICIAL FEMORAL ARTERY AND KNOWN OCCLUSION OF THE TIBIOFIBULAR TRACT, RIGHT FEMORAL ARTERY AND RIGHT POSTERIOR TIBIAL ARTERY. INTERVENTION INCLUDED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE IN-STENT STENOSIS. FOLLOWING PTA, SONOGRAM SHOWED GOOD RESULTS. 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-06-060-120-G2 302041

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R