BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM 80 CM

    MDR report key: 5376771 · Received February 1, 2005

    Report

    Report Number
    9616099-2005-00085
    Event Type
    Malfunction
    Date Received
    February 1, 2005
    Date of Event
    January 5, 2005
    Report Date
    January 28, 2005
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT WE RECEIVED INDICATED THAT AN EXPIRED STENT WAS PLACED IN A PT IN THE RIGHT ILIAC. THERE WERE NO ADVERSE EFFECTS TO THE PT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION OR TESTING. THEREFORE, PLEASE NOTE THE FOLLOWING: CLINICAL IMPRESSIO: THE REPORTED COMPLAINT WAS "USE OF AN EXPIRED SMART CONTROL STENT." THERE WAS NO REPORT OF INCORRECT OR INAPPROPRIATE LABELING. LOT HISTORY REVIEW: THERE IS ONE COMPLAINT REPORTED FOR THIS STERILE LOT NUMBER TO DATE AND THIS IS THE FIRST OF THIS TYPE. CATALOG HISTORY REVIEW: THIS IS THE FIRST REPORTED COMPLAINT OF THIS TYPE FOR THIS CATALOG NUMBER IN THE PREVIOUS SIX MONTHS TO THE ALERT DATE. CONCLUSION: NO PRODUCT WAS RETURNED. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THIS STERILE LOT NUMBER TO DAE AND NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THE CATALOG REPORTED OVER THE PAST SIX MONTHS PREVIOUS TO THE ALERT DAE. MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES HAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT WERE FOUND. LABELS ATTACHED TO ROUTE SHEET SHOWED THAT PRODUCT INVOLVED ON THIS COMPLAINT WAS PROPERLY LABELED AND THERE WAS NO DISCREPANCY FOUND WITH ITS EXPIRATION DATE HOWEVER THE EVENT DATE REPORTED FOR THIS COMPLAINT REVEALED THAT PRODUCT WAS USED AFTER THE EXPIRATION DATE. INSPECTIONS ARE IN PLACE TO PREVENT AND DETECT EXPIRED SES PRODUCTS FROM LEAVING THE FACILITY. THE IFU OF THIS PRODUCT WARNS TO USE THE STENT SYSTEM PRIOR TO THE "USE BY" DATE SPECIFIED ON THE PACKAGE. FAILURE REPORTED COULD NOT BE CONSIDERED AS MANUFACTURING RELATED, THE GIVING USE OF PRODUCT AFTER DATE STATED IN PACKAGE COULD NOT BE DETERMINED. CORDIS CORPORATION WILL NOT BE RESPONSIBLE FOR ANY DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM EXPIRED PRODUCT USE. THEREFORE, NO ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    EXPIRED STENT WAS PLACED IN A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM 80 CM SELF EXPANDING STENTS FGE CORDIS DE MEXICO NA 51102112

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR