BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERCROSS 035

    MDR report key: 6731692 · Received July 21, 2017

    Report

    Report Number
    2183870-2017-00312
    Event Type
    Injury
    Date Received
    July 21, 2017
    Date of Event
    March 29, 2017
    Report Date
    June 23, 2017
    Manufacturer
    COVIDIEN
    Product Code
    LIT
    PMA / PMN Number
    K082579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: YEAR ONLY VALID.

    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 150 MM) 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
    512561 EVERCROSS 035 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention