BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1675647 · Received May 5, 2010

    Report

    Report Number
    3005325609-2010-00007
    Event Type
    Injury
    Date Received
    May 5, 2010
    Date of Event
    February 23, 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

    PREVIOUS EVENTS OF THIS TYPE WERE REVIEWED . DUE TO STENT ELONGATION EVENTS REPORTED FROM TWO HOSPITALS IN (B) (6), A CAPA WAS OPENED. THE CAUSE OF THE STENT ELONGATION WAS FOUND TO BE IMPROPER VESSEL PREPARATION. RETRAINING OF THE PHYSICIANS WAS SUBSEQUENTLY COMPLETED. 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 A STENT PLACED INTO HER LEFT FEMORAL ARTERY AND APPROXIMATELY 1 YEAR LATER BEGAN EXPERIENCING PAIN IN HER LEFT LEG. THE CAUSE OF THE PAIN WAS FOUND TO BE IN-STENT RESTENOSIS. THE PATIENT WAS HOSPITALIZED AND INTERVENTION TO ALLEVIATE THE RESTENOSIS WAS PERFORMED. THE INTERVENTION INCLUDED CUTTING BALLOON PTA AND PTA (DRUG-COATED). FURTHER INVESTIGATION OF THIS EVENT CONCLUDED THAT THE STENT WAS ELONGATED DURING THE INITIAL IMPLANT ((B) (6) 2009). THE NOMINAL STENT LENGTH WAS 150MM AND IT WAS ELONGATED TO 321MM. THE EVENT WAS LIKELY DUE TO IMPROPER VESSEL PREPARATION CAUSING ELONGATION OF THE STENT RESULTING IN IN-STENT RESTENOSIS.

    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 FO0244

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R