BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE STENT SYSTEM

    MDR report key: 1670981 · Received April 28, 2010

    Report

    Report Number
    2953200-2010-00731
    Event Type
    Injury
    Date Received
    April 28, 2010
    Date of Event
    March 23, 2011
    Report Date
    March 29, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K062264
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT HAD 1 COMPLETE SE STENT IMPLANTED TO THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS REPORTED THAT THE STENT WAS SUCCESSFULLY DEPLOYED. TEN MONTHS POST INDEX PROCEDURE, THE PATIENT WAS REFERRED FOR AN ABDOMINAL AORTOGRAM AND BILATERAL LOWER EXTREMITY RUNOFFS FOR CONTINUED CLAUDICATION SYMPTOMS AND ABNORMAL ABI'S. THE LEFT LOWER EXTREMITY ANGIOGRAPHY SHOWED THE LEFT SFA TO BE SEVERELY DISEASED AND SUBTOTALLY OCCLUDED WITH 99% STENOSIS AT THE LEVEL OF THE STENT. LEFT FEM-POP (ABOVE KNEE) BYPASS WITH REVERSE SAPHENOUS VEIN PERFORMED. THE TREATMENT WAS SUCCESSFUL. THE INVESTIGATOR HAS INDICATED THAT THE REPORTED EVENT IS PROBABLY RELATED TO THE STUDY STENT. COMPLETE SE IS CURRENTLY INDICATED FOR USE IN BILIARY/ILIAC ARTERIES, AND IS UNDER IDE INVESTIGATION FOR SFA INDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE STENT SYSTEM FGE MEDTRONIC CARDIOVASCULAR NA V00164465

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention TAKING CLOPIDOGREL OR TICLOPIDINE| TAKING CLOPIDOGREL OR TICLOPIDINE