BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2598950 · Received May 30, 2012

    Report

    Report Number
    3005325609-2012-00015
    Event Type
    Injury
    Date Received
    May 30, 2012
    Date of Event
    April 25, 2012
    Report Date
    May 3, 2012
    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

    CONCLUSION - THERE IS NO INDICATION OF A DEVICE MALFUNCTION. THE CAUSE OF THE EVENT IS LIKELY DUE TO THE PT'S DISEASE PROGRESSION. THE DEVICE HAS THE CE MARK FOR THE PERIPHERAL VASCULAR INDICATION IN EUROPE. THE PT HAD TWO STENTS AND BOTH HAD RESTENOSIS (REF 3005325609-2012-00016).

    Description of Event or Problem · 1

    THE PT WAS INCLUDED IN THE (B)(4) REGISTRY. APPROX THREE YEARS AFTER THE IMPLANT, THE PT PRESENTED WITH PAIN. A DUPLEX SONOGRAPHY SHOWED APPROX 70% STENOSIS. A BALLOON PTA WAS PERFORMED TO TREAT THE OCCLUSION WITH GOOD ANGIOGRAPHIC RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. SE-05-150-120-G2 00258039

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R