BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4490038 · Received February 6, 2015

    Report

    Report Number
    9616099-2015-00057
    Event Type
    Injury
    Date Received
    February 6, 2015
    Date of Event
    May 15, 2013
    Report Date
    January 14, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CORDIS SMART CONTROL TRANSHEPATIC BILIARY STENT PATIENT CALLED FOR STENT CARD REPLACEMENT AND ADDITIONALLY REPORTED ADVERSE EVENTS. PATIENT HAD A SMART CONTROL STENT IMPLANTED IN THE LEFT "ABOVE KNEE WHERE LEG BENDS" FOR A "BLOCKAGE" ON U/U/U, "SEVERAL YEARS AGO" IN 2004 OR 2005. THIS WAS PERFORMED AS AN OUT-PATIENT PROCEDURE. ON U/U/U PATIENT EXPERIENCED AN UNSPECIFIED EVENT WHICH RESULTED IN AN UNSPECIFIED ABBOTT STENT BEING IMPLANTED IN THE LEFT "ABOVE KNEE WHERE LEG BENDS BUT HIGHER THAN THE FIRST STENT, MAY BE A DIFFERENT VEIN NOT CONNECTED TO YOURS" ON (B)(6) 2013. THIS WAS PERFORMED AS AN OUT-PATIENT PROCEDURE. ADDITIONAL ATTEMPTS WERE MADE WITHOUT SUCCESS TO OBTAIN ADDITIONAL INFORMATION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. IN-STENT RESTENOSIS (ISR) IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. VESSEL OCCLUSION, RESTENOSIS, INTIMAL HYPERPLASIA OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT INFORMATION PROVIDED BY THE CUSTOMER WAS SMART CONTROL STENT PRODUCT (B)(4), SIZE 7MM X 60MM 6F., LOT NUMBER AB905284. NEITHER WAS RECOGNIZED AS VALID. CLARIFICATION HAS BEEN REQUESTED FROM THE CUSTOMER. CONTINUED FROM CONCOMITANT MEDICATIONS: PLAVIX (GENERIC CLOPIDOGREL) 75MG TABLET ONCE DAILY; AZOR 10/20MG ONCE DAILY; BYSTOLIC 5MG DAILY; ATORVASTATIN (GENERIC LIPITOR) 20MG/ONCE DAILY. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    A CORDIS SMART CONTROL TRANSHEPATIC BILIARY STENT PATIENT CALLED FOR STENT CARD REPLACEMENT AND ADDITIONALLY REPORTED ADVERSE EVENTS. PATIENT HAD A SMART CONTROL STENT IMPLANTED IN THE LEFT "ABOVE KNEE WHERE LEG BENDS" FOR A "BLOCKAGE" ON U/U/U, "SEVERAL YEARS AGO" IN 2004 OR 2005. THIS WAS PERFORMED AS AN OUT-PATIENT PROCEDURE. ON U/U/U PATIENT EXPERIENCED AN UNSPECIFIED EVENT WHICH RESULTED IN AN UNSPECIFIED ABBOTT STENT BEING IMPLANTED IN THE LEFT "ABOVE KNEE WHERE LEG BENDS BUT HIGHER THAN THE FIRST STENT, MAY BE A DIFFERENT VEIN NOT CONNECTED TO YOURS" ON (B)(6) 2013. THIS WAS PERFORMED AS AN OUT-PATIENT PROCEDURE. ADDITIONAL DETAILS CANNOT BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87754 S.M.A.R.T. NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R