BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR XL BILIARY STENT

    MDR report key: 1374033 · Received February 13, 2009

    Report

    Report Number
    9681442-2009-00012
    Event Type
    Malfunction
    Date Received
    February 13, 2009
    Date of Event
    January 21, 2009
    Report Date
    January 22, 2009
    Manufacturer
    ANGIOMED GMBH & CO, MEDIZINTECHNIK
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING RECORDS SHOW THAT NO REMARKABLE INCIDENTS OCCURRED. THE DEVICE REMAINS IMPLANTED; THEREFORE, A DEVICE EVALUATION COULD NOT BE CONDUCTED. THIS EVENT IS STILL UNDER INVESTIGATION. THIS REPORT IS BEING SUBMITTED, AS THIS PRODUCT IS THE SAME OR SIMILAR TO A DEVICE 510K #K060487 CURRENTLY DISTRIBUTED IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT FRACTURED. THE STENT WAS DEPLOYED WITHOUT ANY PROBLEMS; THEN A BALLOON CATHETER WAS ADVANCED; HOWEVER, THE BALLOON WOULD NOT ADVANCE THROUGH A NON CALCIFIED SEGMENT; REPORTEDLY IT WAS A DISTORTED FRACTURED SEGMENT OF THE RECENTLY DEPLOYED STENT. IT WAS NECESSARY TO USE A SMALLER BALLOON TO ADVANCE THROUGH THE SEGMENT AND THEN A LARGER BALLOON AND FINALLY DEPLOYED A COMPETITOR'S STENT. THE WIRE WAS NOT MOVED BETWEEN STENT INSERTION AND ATTEMPTED PASSAGE OF THE BALLOONS. THE PROCEDURE WAS COMPLETED AND THERE WAS NO INJURY TO THE PATIENT. REPORTEDLY, PRE-STENT IMAGES SHOWED THE SFA/POPLITEAL ARTERY AFTER IT HAD BEEN BALLOONED AT THE CALCIFIED AREA AT THE LEVEL OF THE PATELLA. A ZOOMED IMAGE OF THE STENT, SHOWS THE STENT FRACTURED IN ONE AREA AND POSSIBLY STRETCHED PROXIMALLY TO THAT. POST-STENT IMAGES SHOW THE STENT FULLY DEPLOYED, WITH A COMPETITOR'S STENT DEPLOYED WITHIN THE APPARENT FRACTURED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR XL BILIARY STENT FGE ANGIOMED GMBH & CO, MEDIZINTECHNIK 58568787

    Patients

    Seq Age Sex Outcome Treatment
    1