BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE SFA-IDE

    MDR report key: 1342383 · Received March 11, 2009

    Report

    Report Number
    2953200-2009-00304
    Event Type
    Malfunction
    Date Received
    March 11, 2009
    Date of Event
    February 5, 2009
    Report Date
    February 9, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K062264
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CODES, CONCLUSIONS: 80% DIFFUSE LESION. SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    A 7MM DIAMETER X 150 MM LENGTH COMPLETE SE STENT DELIVERY SYSTEM WAS SELECTED FOR INSERTION INTO A PT FOR THE TREATMENT OF AN 80% DIFFUSE RIGHT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT WHEN THE STENT WAS DEPLOYED, A DISSECTION WAS NOTED PROXIMAL TO THE STENT. THE PHYSICIAN TREATED THE DISSECTION WITH A SECOND COMPLETE SE STENT. IT WAS REPORTED THAT THE PT IS FINE AND WAS DISCHARGED. THE INVESTIGATOR HAS INDICATED THAT THE EVENT WAS RELATED TO THE STUDY STENT, AND THAT THERE IS A DEFINITE RELATION BETWEEN THE EVENT AND THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE SFA-IDE FGE MEDTRONIC CARDIOVASCULAR NA V00173490

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR