BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S.M.A.R.T. NITINOL STENT SYSTEM

    MDR report key: 1030227 · Received April 16, 2008

    Report

    Report Number
    9616099-2008-01011
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    November 16, 2007
    Report Date
    March 19, 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 IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION TO BE SUBMITTED 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG REPORT #9616099-2008-01010 AND 9616099-2008-01011.

    Description of Event or Problem · 1

    IN 2007, THE PT RETURNED TO THE HOSPITAL WITH A NEW STENOSIS IN THE SFA, AND SYMPTOMS OF CLAUDICATION. THE PT IS A MALE WHO IS ENROLLED IN THE TRIAL. THE INDEX LESION WAS THE LEFT PROXIMAL AND MID SUPERFICIAL FEMORAL ARTERY. THE INDEX PROCEDURE WAS PERFORMED ON TWO DAYS LATER. THE VESSEL ANATOMY AT THE LESION SITE WAS STRAIGHT AND TYPE OF LESION RESTENOTIC. LESION LOCATION IS 13CM ABOVE SUPERIOR EDGE OF THE PATELLA. TOTAL LESION LENGTH IS 220MM AND TOTALLY OCCLUDED. REFERENCE VESSEL DIAMETER WAS 5.0MM. ACCESS METHOD WAS PERCUTANEOUS AND PUNCTURE SITE IPSILATERAL. FOR PRE- AND POST DILATION A PHERON BIOTRONIC BALLOON (5 X 10MM) WAS USED. TWO SMART STENTS (7 X 120MM AND 6 X 120MM) WERE IMPLANTED IN THE PROXIMAL AND MID LEFT SFA. NO DISSECTIONS WERE REPORTED DURING PROCEDURE. ON ORIGINAL DATE, THE PT RETURNED TO THE HOSPITAL WITH A NEW STENOSIS IN THE SFA, AND SYMPTOMS OF CLAUDICATION. IT IS UNK IF THE NEW LESION WAS WITHIN 5MM OF THE PREVIOUSLY PLACED STENTS. ACTION TAKEN: ANGIOPLASTY AND STENTING OF THE LEFT SFA, DISTAL TO TARGET LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S.M.A.R.T. NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA X0805909

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R PHERON BIOTRONIC BALLOON (5 X 10MM)