BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1616505 · Received February 24, 2010

    Report

    Report Number
    3005325609-2010-00001
    Event Type
    Injury
    Date Received
    February 24, 2010
    Date of Event
    December 30, 2009
    Report Date
    January 27, 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 STENT IS CURRENTLY IMPLANTED. THE CAUSE OF THE EVENT IS UNKNOWN. (B) (4) IS CURRENTLY WAITING ON THE OP NOTES FROM THE INITIAL IMPLANT ((B) (6) 2008) TO DETERMINE IF ANY THING OCCURRED DURING THE PROCEDURE THAT MAY HAVE CONTRIBUTED TO THE IN-STENT RESTENOSIS. THE DEVICE HOLDS THE CE MARK FOR THE INDICATION OF THE PERIPHERAL VASCULATURE IN (B) (6) WHERE THIS EVENT OCCURRED.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN (B) (6) AND INVOLVED A PATIENT IN THE (B) (6) REGISTRY. THE PATIENT DEVELOPED IN-STENT RESTENOSIS IN THE RIGHT POPLITEAL ARTERY. THE PATIENT HAD BEEN EXPERIENCING CLAUDICATION IN HIS RIGHT CALF FOR A FEW DAYS PRIOR TO THE INTERVENTION. IT WAS REPORTED THAT THE ARTERY AT THE LEVEL OF THE KNEE JOINT CAVITY WAS 50% STENOSED. RECANALIZATION OF THE OCCLUSION WAS PERFORMED ON THE NARROWED SEGMENT. FURTHER STENOSIS OUTSIDE THE STENTED LESION WAS OBSERVED AND A 40MM STENT WAS IMPLANTED. THE PROCEDURE WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. SE-05-080-120-G2 F00234

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization 8F ROTAREX S THROMBECTOMY CATHETER