BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1831712 · Received September 13, 2010

    Report

    Report Number
    9616099-2010-00677
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Report Date
    August 23, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE EVENT DATE IS UNKNOWN. INSTEAD OF AN 8CM SMART STENT, AS LABELED ON THE PACKAGE, THERE WAS A 10CM SMART STENT IN THE PACKAGE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THERE IS NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT THE RETURN OF THE PRODUCT OR FILMS OF THE PROCEDURE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    INSTEAD OF AN 8CM SMART STENT, AS LABELED ON THE PACKAGE, THERE WAS A 10CM SMART STENT IN THE PACKAGE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1