BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2230698 · Received August 17, 2011

    Report

    Report Number
    3005325609-2011-00012
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 19, 2011
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K093893
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NOT INDICATION OF A DEVICE MALFUNCTION. THE CAUSE OF THE EVENT IS LIKELY DUE TO THE PT'S DISEASE PROGRESSION. THE REPORTED ELONGATION OF THE STENT IS MINIMAL AND LIKELY DID NOT CONTRIBUTE TO THE RESTENOSIS.

    Description of Event or Problem · 1

    THE REPORT WAS RECEIVED FOR A REGISTRY PT IN (B)(6). THE PT WAS HOSPITALIZED DUE TO IN-STENT RESTENOSIS IN THE RIGHT SFA AND OCCLUSION OF ARTERIC PROFUNDA FEMORAL. A DRUG COATED BALLOON ANGIOPLASTY OF THE STENT AND DRUG COATED RECANALIZATION OF THE ARTERIC PROFUNDA FEMORAL WAS PERFORMED. IT WAS REPORTED THAT THIS INTERVENTION IMPROVED THE PT'S CONDITION. ADD'L INFO INDICATES THAT DURING THE IMPLANT, APPROX ONE YEAR AGO, A COMPLICATION OF "GEOGRAPHICAL STENT MISS" WAS NOTED WITH A RELATIONSHIP TO THE DEVICE AND PROCEDURE AND A SEVERITY OF MILD. THE IMPLANT OF THE STENT WAS NOTED AS BEING "A LITTLE TOO LONG WITH EXTENSION INTO THE CFA." THE REGISTRY DATA INDICATES THAT THE FINAL DEPLOYED STENT LENGTH WAS 148.81 MM; THIS RESULTED IN 28.81 MM BEYOND THE NOMINAL STENT LENGTH. THE REASON FOR THE ELONGATION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. SE-06-120-120-G3 01011044

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R