BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE SFA

    MDR report key: 4506958 · Received February 11, 2015

    Report

    Report Number
    9612164-2015-00216
    Event Type
    Malfunction
    Date Received
    February 11, 2015
    Date of Event
    January 13, 2015
    Report Date
    January 13, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: (ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED). (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. DEVICE NOT RETURNED FOR EVALUATION CODE CONCLUSION. UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). (ROOT CAUSE COULD NOT BE DETERMINED). DEVICE NOT RETURNED -NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    A COMPLETE SE WAS BEING USED TO TREAT THE RIGHT DISTAL SFA. THE LESION WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED. DEVICE WAS REMOVED FROM PACKAGING PER IFU. DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. DEVICE WAS PREPPED PRIOR TO USE WITH NO ISSUES NOTED. IT IS REPORTED THAT DURING IMPLANTION THE STENT JUMPED A LITTLE BIT. THE STENT WAS IMPLANTED OK AND FINAL RESULT WAS VERY GOOD. THERE WAS NO PATIENT INJURY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100514 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1