BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1675646 · Received May 5, 2010

    Report

    Report Number
    3005325609-2010-00006
    Event Type
    Injury
    Date Received
    May 5, 2010
    Date of Event
    March 9, 2010
    Report Date
    April 16, 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 REPORTED RESTENOSIS WAS CAUSED BY THE PATIENT'S DISEASE PROGRESSION. THIS EVENT OCCURRED IN A STRONG REGISTRY PATIENT IN (B) (6). THE SUPERA DEVICE HOLDS THE (B) (4) FOR THE INDICATION OF PERIPHERAL VASCULAR USE.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN (B) (6) AND INVOLVED A PATIENT TREATED IN THE STRONG REGISTRY. THE PATIENT INITIALLY HAD THREE STENTS PLACED INTO HER LEFT SUPERFICIAL FEMORAL ARTERY AND APPROX ONE YEAR LATER BEGAN EXPERIENCING PAIN. THE CAUSE OF THE PAIN WAS FOUND TO BE IN-STENT RESTENOSIS WITH TOTAL OCCLUSION OF THE TARGET LESION. THE PATIENT WAS HOSPITALIZED AND INTERVENTION TO ALLEVIATE THE RESTENOSIS WAS PERFORMED. THE INTERVENTION INCLUDED ROTAREX-ASSISTED RECANALIZATION, ANGIOPLASTY AND AN ADDITIONAL STENT IMPLANT. THE FINAL ANGIOGRAPHY SHOWS GOOD RESULTS IN THE TREATED VASCULAR SEGMENT WITH VERY GOOD OUTFLOW THROUGH THE ANTERIOR TIBIAL ARTERY AND POSTERIOR TO DISTAL SEGMENTS OF THE TIBIAL ARTERY. THE CAUSE OF THE EVENT IS DUE TO DISEASE PROGRESSION; THERE WERE NO SIGNS OF A STENT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. SE-06-150-120-G2 00258039

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R