BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD

    MDR report key: 6731707 · Received July 21, 2017

    Report

    Report Number
    2183870-2017-00313
    Event Type
    Injury
    Date Received
    July 21, 2017
    Date of Event
    July 6, 2016
    Report Date
    June 23, 2017
    Manufacturer
    COVIDIEN
    Product Code
    NIP
    PMA / PMN Number
    P110023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT WAS PREVIOUSLY TREATED WITH AN EVERFLEX + IN THE RIGHT SFA ((B)(6) 2013). REVASCULARIZATION WAS PERFORMED WITH AN EVERCROSS PTA CATHETER (4 X 150MM) AND TWO IN.PACT ADMIRAL DEBS ((B)(6) 2014). RESTENOSIS OF THE RIGHT SFA WAS TREATED WITH PACIFIC AND INPACT PACIFIC BALLOONS ((B)(6) 2016). OCCLUSION TO THE RIGHT SFA ((B)(6) 2017), AND WAS TREATED WITH 1 EVERCROSS BALLOON AND NON-MEDTRONIC DEB AND STENTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511320 EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD STENT, SUPERFICIAL FEMORAL ARTERY NIP COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention