BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE SFA

    MDR report key: 6140616 · Received December 2, 2016

    Report

    Report Number
    9612164-2016-01214
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 3, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A COMPLETE SE SFA STENT WAS IMPLANTED INTO THE SFA. APPROXIMATELY 88 MONTHS LATER, THE PATIENT SUFFERED FROM WORSENING OF PAD LEFT - HIGH GRADE INSTENT RESTENOSIS DISTAL SFA LEFT. THIS EVENT WAS TREATED BY A TL REVASCULARIZATION THE FOLLOWING DAY USING A DCB. PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793034 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention