BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE BILIARY

    MDR report key: 4223620 · Received November 4, 2014

    Report

    Report Number
    9612164-2014-01416
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 6, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    FGE
    PMA / PMN Number
    K062264
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: PATIENTS CONDITION AFFECTED EFFECTIVENESS OF DEVICE (MODERATELY CALCIFIED, TORTUOUS LESION WITH 80% STENOSIS). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE NOT PROVIDED FOR REVIEW). (DEVICE NOT RETURNED FOR EVALUATION). CONCLUSION RESULTS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (MODERATELY CALCIFIED, TORTUOUS LESION WITH 80% STENOSIS). UNABLE TO CONFIRM COMPLAINT (DEVICE NOT PROVIDED FOR REVIEW). (B)(4).

    Description of Event or Problem · 1

    A COMPLETE SE PERIPHERAL STENT WAS BEING USED TO TREAT A LESION IN THE POPLITEAL. THE LESION WAS MODERATELY CALCIFIED, TORTUOUS WITH 80% STENOSIS. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH 10% STENOSIS REMAINED POST DILATION. NO RESISTANCE WAS EXPERIENCED WHEN ADVANCING TOWARDS LESION AND FORCE WAS NOT USED. IT WAS REPORTED THAT THE COMPLETE SE DEVICE WAS PLACED IN THE ABOVE THE KNEE POPLITEAL SUCCESSFULLY. RESISTANCE WAS EXPERIENCED DURING REMOVAL OF THE DELIVERY SYSTEM AND THE STENT DELIVERY SYSTEM BECAME CAUGHT ON THE NEWLY DEPLOYED STENT. THE DISTAL EDGE OF THE STENT ENFOLDED. THE PHYSICIAN POST-DILATED WITH A BALLOON AND PROCEDURE WAS COMPLETED. THE PATIENT IS REPORTED TO BE FINE POST PROCEDURE. NO OTHER CLINICAL SEQUELAE WERE REPORTED FOR THIS EVENT STILL IMAGE REVIEW: ONE STILL PROCEDURAL IMAGE WAS RETURNED FOR REVIEW. REVIEW OF THE RETURNED STILL IMAGE SHOWED THE STENT TO BE EXPANDED IN THE VESSEL, THE DISTAL SECTION THE STENT DOES NOT APPEAR TO BE EXPANDED EVENLY. THE IMAGE APPEARS TO SHOW THE DISTAL SECTION OF THE STENT IS SLIGHTLY DEFORMED. THE PROCEDURAL STILL IMAGE SHOW A TARGET LESION WITH SIGNIFICANT STENOSIS EVIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708062 COMPLETE SE BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE MEDTRONIC IRELAND 0007267423

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention