BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE SFA

    MDR report key: 1438739 · Received May 7, 2009

    Report

    Report Number
    2953200-2009-00578
    Event Type
    Malfunction
    Date Received
    May 7, 2009
    Date of Event
    March 26, 2009
    Report Date
    April 7, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K062264
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: DISSECTION. A 90% STENOSIS. CONCLUSIONS: A 90% STENOSIS.

    Description of Event or Problem · 1

    A 6MM DIAMETER X 150MM LENGTH COMPLETE SE STENT DELIVERY SYS WAS SELECTED FOR INSERTION INTO A PT FOR THE TREATMENT OF LEFT SFA LESION. IT IS UNK IF THE LESION WAS PRE-DILATED. THE VESSEL MORPHOLOGY WAS REPORTED AS 90% STENOSIS. IT WAS REPORTED THAT A DISSECTION OCCURRED DURING STENT PLACEMENT; DISTALLY TO THE IMPLANTED STENT. THE DISSECTION WAS TREATED WITH BALLOON ANGIOPLASTY. THE PT HAS BEEN DISCHARGED. THE INVESTIGATOR HAS INDICATED THAT THE EVENT WAS DEFINITELY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE SFA FGE MEDTRONIC CARDIOVASCULAR NA V00168353

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK