BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2267783 · Received September 23, 2011

    Report

    Report Number
    3005325609-2011-00015
    Event Type
    Injury
    Date Received
    September 23, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 24, 2011
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K093893
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER PRODUCT EXPERIENCE REPORTS OF THIS TYPE AND THE DEVICE HISTORY RECORD WERE REVIEWED. THE CAUSE WAS LIKELY DUE TO THE PHYSICIANS REPEATED ATTEMPTS TO CROSS A LESION THAT WAS NO PREPPED. WE WERE UNABLE TO OBTAIN THE PT INFO (AGE, GENDER AND WEIGHT). SEVERAL ATTEMPTS WERE MADE TO GET THIS INFO AND THE PHYSICIAN AND HOSPITAL WOULD NOT RELEASE IT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT THE STENT INTO A TOTALLY OCCLUDED RIGHT POPLITEAL ARTERY VIA A CONTRALATERAL APPROACH. THE INTRODUCER SHEATH WAS INSERTED HOWEVER THERE WAS A 60% OCCLUDED LESION JUST DISTAL TO THE INTRODUCER SHEATH. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO CROSS THE STENT DELIVERY SYSTEM THROUGH THIS OCCLUDED LESION. THE PHYSICIAN DECIDED TO REMOVE THE STENT DELIVERY SYSTEM FROM THE INTRODUCER AND IN DOING SO THE GUIDEWIRE ACCESS IN THE VESSEL WAS LOST. THE PHYSICIAN OBSERVED SOME DAMAGE TO THE DISTAL END OF THE STENT DELIVERY SYSTEM DUE TO THE INSERTION ATTEMPTS. ACCESSING THE VESSEL AGAIN WITH A WIRE WAS INHIBITED DUE TO A DISSECTION FLAT THAT WAS LIKELY CREATED DURING THE ATTEMPTS TO CROSS THE LESION. THE PHYSICIAN DECIDED TO GAIN VESSEL ACCESS THROUGH THE MID-SFA AND THE DISSECTION FLAP WAS REPAIRED BY BALLOON ANGIOPLASTY. A STENT WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. SE-06-080-120-G3 01044042

    Patients

    Seq Age Sex Outcome Treatment
    1 7FR DESTINATION SHEATH| .014 CORONARY WIRE