BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1870822 · Received October 11, 2010

    Report

    Report Number
    3005325609-2010-00012
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 13, 2010
    Report Date
    September 15, 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

    THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THE CAUSE OF THE EVENT IS LIKELY THE PT'S DISEASE PROGRESSION.

    Description of Event or Problem · 1

    THE PT WAS HOSPITALIZED DUE TO LESIONS IN HIS RIGHT LOWER LEG. THE PT IS ENROLLED IN THE (B)(4) REGISTRY IN (B)(6). THE PT WAS TREATED WITH A STENT IN THE DISTAL RIGHT SFA IN (B)(6)2009. EIGHTEEN MONTHS LATER, THE PT RETURNED WITH A CRITICAL LESION IN THE RIGHT COMMON FEMORAL ARTERY, AS WELL AS RESTENOSIS OF THE SUPERA STENT. THERE WAS NO REPORT OF VESSEL DISSECTION OR OTHER PERI-PROCEDURAL EVENTS REPORTED AT THE INITIAL PROCEDURE THAT COULD HAVE CONTRIBUTED TO A LATER STENOSIS. IT IS BELIEVED THAT THE IN-STENT RESTENOSIS IS NOT DIRECTLY THE RESULT OF THE STENT BUT RATHER THE RESULT OF DISEASE PROGRESSION IN THE SFA GIVEN THAT THE RESTENOSIS WAS NOT IDENTIFIED FOR 18 MONTHS POST INDEX PROCEDURE, AND THERE WAS ALSO A NEW LESION IN THE ADJACENT RIGHT COMMON FEMORAL ARTERY. ANGIOPLASTY WAS PERFORMED TO ALLEVIATE THE RESTENOSIS.

    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 F0241

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R