BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE SFA

    MDR report key: 7074344 · Received December 1, 2017

    Report

    Report Number
    9612164-2017-01695
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    September 14, 2017
    Report Date
    March 3, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: SPONSOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO PROCEDURE OR PACLITAXEL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, A COMPLETE SE WAS IMPLANTED TO TREAT A DISSECTION. APPROXIMATELY 49 MONTHS POST PROCEDURE, PATIENT SUFFERED THROMBOTIC REOCCLUSION OF THE TARGET VESSEL. INVESTIGATOR ASSESSED THE EVENT IS NOT RELATED TO THE STUDY DEVICE, PROCEDURE OR PACLITAXEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856269 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R