BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE SFA

    MDR report key: 7522662 · Received May 17, 2018

    Report

    Report Number
    9612164-2018-01134
    Event Type
    Injury
    Date Received
    May 17, 2018
    Date of Event
    November 18, 2016
    Report Date
    May 17, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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

    DURING THE INDEX PROCEDURE ((B)(6) 2013) THE RIGHT DISTAL SFA WAS TREATED WITH AN INPACT ADMIRAL BALLOON CATHETER. APPROXIMATELY 40 MONTHS POST INDEX PROCEDURE THE PATIENT UNDERWENT TARGET VESSEL REVASCULARISATION OF THE RIGHT DISTAL SFA ((B)(6) 2016) USING AN ADMIRAL XTREME PTA AND A COMPLETE SE STENT. A GRADE B DISSECTION OCCURRED. THE PATIENT HAS RECOVERED. IT IS UNKNOWN WHICH DEVICE CAUSED THE DISSECTION AND IF ANY TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365089 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization