BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1230530 · Received November 12, 2008

    Report

    Report Number
    9616099-2008-02623
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    January 9, 2008
    Report Date
    November 5, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PERTAINING TO THE STUDY INDEX PROCEDURE WAS PROVIDED, AND INDICATED THE FOLLOWING: MEDICATION PREPROCEDURE WAS 75 MG ASPIRIN AND 5000IU HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE TARGET LESION WAS THE MID RIGHT SUPERFICIAL FEMORAL ARTERY. APPROACH WAS IPSILATERAL. CHARACTERISTICS WERE STRAIGHT VESSEL, DE NOVO LESION, TOTAL 110 MM LENGTH WITH OCCLUDED LENGTH 90 MM, CALCIFICATION PRESENT. REFERENCE VESSEL DIAMETER 5MM. THERE WA 100% STENOSIS AFTER DILATION. NO DISSECTION AND ONE SMART 6X100MM STENT WAS PLACED. RESIDUAL DIAMETER STENOSIS WAS 0% AFTER POST DILATION WITH A WANDER 6X40 BALLOON. THERE WERE ADVERSE EFFECTS DURING OR UPON DISCHARGE FOR INDEX PROCEDURE. OTHER DEVICES USED DURING THE INDEX PROCEDURE WERE LISTED AS COBRA (5F) AND TERUMO (5F) SHEATHS, J GUIDE (0.035 INCH) AND SPARTA CORE 14 (0.014 INCH) GUIDEWIRES, AND CONTRAST AGENT VISIPAQUE 320 (50 ML USED). THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. HOWEVER, ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED UNDER THE SUPER STUDY INDICATED APPROXIMATELY 14 MONTHS POST SMART CONTROL STENT IMPLANT, 75 STENOSIS PROXIMAL TO THE STENT WAS OBSERVED. REPORT INDICATED THAT NO ACTION WAS TAKEN AT TIME BUT OUTCOME IS ONGOING. THIS EVENT WAS DETERMINE POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA 50605630

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention MEBEVERINE HYDROCHLORIDE| ARTHROTEC| TEMAZEPAM| LACTULOSE| VITAMIN B12| CA-ANTAGONISTS| STATINS| NITRATES| BETA BLOCKING AGENTS| ASPIRIN| OMEPRAZOLE| CO-CODAMOL