BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE STENT SYSTEM

    MDR report key: 1689634 · Received May 12, 2010

    Report

    Report Number
    2953200-2010-00838
    Event Type
    Injury
    Date Received
    May 12, 2010
    Date of Event
    April 12, 2010
    Report Date
    April 17, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K062264
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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 2 COMPLETE SE STENTS IMPLANTED, 1 TO THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA) AND 1 TO THE RIGHT PROXIMAL SFA (MFR 2953200-2010-00839). THE STENT DEPLOYMENT WAS REPORTED TO BE SUCCESSFUL. AT 6 MONTH FOLLOW UP THE PATIENT COMPLAINED OF CRAMPING IN BOTH CALVES FOR THE PAST 4 MONTHS. AN ANGIOGRAM WAS PERFORMED AND THE TARGET VESSEL WAS SEEN TO BE OCCLUDED. PERCUTANEOUS INTERVENTION WAS REQUIRED. BALLOON ANGIOPLASTY AND STENTING WAS PERFORMED. THE TREATMENT WAS SUCCESSFUL. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS DEFINITELY RELATED TO THE STUDY STENTS. COMPLETE SE IS NOT APPROVED FOR USE IN THE UNITED STATES FOR SFA INDICATION BUT IS SIMILAR TO COMPLETE SE WHICH IS APPROVED FOR BILIARY/ILIAC INDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE STENT SYSTEM FGE MEDTRONIC CARDIOVASCULAR NA V00330258

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention METROPROLOL SUCCINATE| PLAVIX| CITALOPRAM| LIPITOR| HYDROCHLOROTHIAZIDE| ASPIRIN| NITROGLYCERIN| BENAZEPRIL| HYDROBROMIDE| TRANXENE