BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE BILIARY

    MDR report key: 3012118 · Received March 20, 2013

    Report

    Report Number
    9612164-2013-00313
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    FGE
    PMA / PMN Number
    P090006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS AND CONCLUSIONS: RELATED TO OPERATIONAL CONTEXT (THE EXACT ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED HOWEVER, IT IS MOST LIKELY PROCEDURAL RELATED). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN DEPLOYED AN 8MM DIAMETER X 150MM LENGTH COMPLETE SE PERIPHERAL STENT SYSTEM TO TREAT A LESION IN A PATIENT LOCATED IN THE MID SFA THAT WAS REPORTED TO BE DE-BULKED. IT WAS REPORTED THAT THE STENT DEPLOYED IN A NON-UNIFORM FASHION AND THAT THE MARKER BANDS WERE NOT CIRCUMFERENTIAL AND APPEARED TO BE STRETCHED UPON DEPLOYMENT. IT WAS INDICATED THAT THE TIP OF THE DELIVERY SYSTEM MAY HAVE CAUGHT ON THE DEPLOYED STENT DURING REMOVAL. ADDITIONAL BALLOONING WAS CARRIED OUT AS TREATMENT FOR THIS EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. CINE IMAGE REVIEW: PROCEDURAL STILL IMAGES WERE PROVIDED FOR REVIEW. PROCEDURAL STILL IMAGES CONFIRM THE STENT DEFORMATION. ADDITIONAL IMAGES SHOW AN EXPANDED BALLOON IN VESSEL AND THIS IS MOST LIKELY THE ADDITIONAL BALLOONING PERFORMED ON THE STENT. THERE ARE NO IMAGES OF THE STENT DEPLOYMENT OR DELIVERY SYSTEM REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115516 COMPLETE SE BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE MEDTRONIC IRELAND 0006555643

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention