BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1930700 · Received December 14, 2010

    Report

    Report Number
    3005325609-2010-00020
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 9, 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 STRONG REGISTRY IN (B)(6). AT 16 MONTHS POST IMPLANT THE IN-STENT STENOSIS WAS OBSERVED IN THE POPLITEAL ARTERY (RIGHT). INTERVENTION INCLUDED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WITH A BALLOON WAS PERFORMED. FOLLOWING PTA, RESULTS WERE "VERY GOOD." 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-06-040-120-G2 304040

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R