BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE STENT SYSTEM

    MDR report key: 1600903 · Received February 11, 2010

    Report

    Report Number
    2953200-2010-00221
    Event Type
    Injury
    Date Received
    February 11, 2010
    Date of Event
    January 12, 2010
    Report Date
    January 14, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    SECONDARY INTERVENTION, EXTRA DILATATION - (B) (4). EVALUATION RESULTS: (DISSECTION).

    Description of Event or Problem · 1

    THE PATIENT HAD A COMPLETE SE IMPLANTED. AFTER POST-DILATATION A DISSECTION OCCURRED. EXTRA DILATATION WAS PERFORMED. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE. COMPLETE SE IS NOT APPROVED FOR USE IN THE US FOR SFA INDICATION BUT IS SIMILAR TO COMPLETE SE WHICH IS APPROVED FOR BILIARY INDICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Unknown Required Intervention UNK.