BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART NITINOL STENT SYSTEM

    MDR report key: 1111924 · Received August 11, 2008

    Report

    Report Number
    9616099-2008-01951
    Event Type
    Injury
    Date Received
    August 11, 2008
    Date of Event
    June 6, 2006
    Report Date
    July 14, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K020052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE INDEX PROCEDURE WAS PERFORMED IN 2006. THE PT WAS GIVEN 100MG/DAY OF ASPIRIN AND 75MG/DAY OF CLOPIDOGREL 24 HOURS PRIOR TO PROCEDURE, HEPARIN WAS GIVEN AT THE BEGINNING OF THE PROCEDURE; TOTAL DOSE USED DURING PROCEDURE WAS 5000IU. THE ACCESS METHODS WERE PERCUTANEOUS AND PUNCTURE SITE CONTRALATERAL AND NO PRE-DILATION WAS DONE. ONE SMART STENT (7X120MM) WAS IMPLANTED IN THE RIGHT MID-SUPERIOR FEMORAL ARTERY. IN THE PROCEDURE, POST DILATION WAS DONE WITH A PHERON BALLOON (5X80MM). THE VESSEL ANATOMY AT THE LESION SITE WAS STRAIGHT, TYPE OF LESION RESTENOTIC AND THE LESION WAS CALCIFIED AND ECCENTRIC. THE LESION LOCATION IS 10CM ABOVE THE SUPERIOR EDGE OF THE PATELLA, AND THE TOTAL LESION LENGTH WAS 90MM AND TOTALLY OCCLUDED. NO THROMBUS WAS PRESENT AT SITE BEFORE PROCEDURE. THE REFERENCE VESSEL DIAMETER WAS 5.0MM WITH A PERCENTAGE STENOSIS AFTER STENT PLACEMENT AND POST DILATION WAS 30%. THERE WERE NO DISSECTIONS REPORTED DURING PROCEDURE. A PHYSICIAN GENERAL COMMENT ON PROCEDURE WAS REMAINING 50% PROXIMAL TO TREATED DISTAL CA 30-40%. THE MEDICATIONS AT DISCHARGE WERE ASPIRIN AND CLOPIDOGREL. FOUR DAYS AFTER THE PROCEDURE, RESTENOSIS WAS FOUND IN THE IMPLANTED STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA X0805909

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization ASPIRIN| CLOPIDOGREL