BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE SFA

    MDR report key: 5387715 · Received January 25, 2016

    Report

    Report Number
    9612164-2016-00086
    Event Type
    Malfunction
    Date Received
    January 25, 2016
    Date of Event
    January 4, 2016
    Report Date
    January 4, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN IMPLANTED A COMPLETE SE STENT. THE TARGET LESION IN THE MID SUPERFICIAL FEMORAL ARTERY WAS A SOFT TISSUE LESION WITH A LITTLE TORTUOSITY, 60% STENOSIS AND NO CALCIFICATION. THE DEVICE HAD BEEN INSPECTED AND PREPPED PER THE IFU WITH NO ISSUES NOTED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE DEVICE WAS USED POST ITS EXPIRATION DATE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48497 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND 0006978092

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR