BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE STENT SYSTEM

    MDR report key: 1666687 · Received April 22, 2010

    Report

    Report Number
    2953200-2010-00698
    Event Type
    Injury
    Date Received
    April 22, 2010
    Date of Event
    March 24, 2010
    Report Date
    March 25, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K062264
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). RESULTS: OCCLUSION OF SFA OR DISTAL VASCULATURE.

    Description of Event or Problem · 1

    THE PATIENT HAD A COMPLETE SE STENT IMPLANTED TO THE POPLITEAL ARTERY. STENT DEPLOYMENT WAS SUCCESSFUL. APPROXIMATELY 5.5 MONTHS POST INDEX PROCEDURE THE PATIENT REQUIRED HOSPITALIZATION DUE TO IN-STENT OCCLUSION OF THE ARTERIA POPLITEA LESION. VASCULAR INTERVENTION WAS REQUIRED. THE PATIENT RECOVERED WITH TREATMENT. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS DEFINITELY RELATED TO THE STUDY DEVICE. COMPLETE SE IS CURRENTLY INDICATED FOR USE IN BILIARY/ARTERIES, AND IS UNDER IDE INVESTIGATION FOR SFA INDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE STENT SYSTEM FGE MEDTRONIC CARDIOVASCULAR NA V00185437

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention