BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1140561 · Received August 28, 2008

    Report

    Report Number
    9616099-2008-02102
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 9, 2008
    Report Date
    August 15, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THE SMART CONTROL STENT ON SDS WAS KINKED AND PARTIALLY DEPLOYED WHEN REMOVED FROM STERILE PACKAGE. THERE WAS NO PATIENT, TARGET VESSEL OR PROCEDURE SPECIFIC INFORMATION AVAILABLE. THE PRODUCT WAS OPENED AND THE KINK AND PARTIAL DEPLOYMENT WERE NOTED. THE DEVICE WAS NOT USED CLINICALLY AND WAS RETURNED FOR ANALYSIS. THERE WAS NO REPORTED PATIENT INJURY. ONE NON-STERILE SMART CONTROL SES 6 X 80 MM WAS RECEIVED FOR ANALYSIS. DURING VISUAL ANALYSIS SEVERAL KINKS WERE OBSERVED IN THE DISTAL SECTION OF THE SES. THE BRITE TIP WAS SPLIT. THE STENT WAS PRE-DEPLOYED 0.3 CM. HOWEVER, IT MIGHT HAVE BEEN CAUSED DURING THE UNIT TRANSPORTATION. THE ACTUAL SES PACKAGING WAS NOT RETURNED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE KINKED/BENT SES REPORTED BY THE CUSTOMER WAS CONFIRMED. THE KINKED SES AS WELL AS THE SPLIT BRITE TIP ALREADY HAS BEEN DETERMINED AS PACKAGING RELATED. ACTION TAKEN: STRATEGIC CAPA 105 WAS OPENED AND IMPLEMENTED ON 11/14/07 TO ADDRESS TIP DAMAGE ISSUES ON SMART CONTROL SES. THIS LOT OF PRODUCTS WAS MANUFACTURED ON 1/09/07. THE CAPA IS IN THE MONITORING PHASE. THE COMPLAINTS OF KINKED SMART CONTROL SDS AND PARTIALLY DEPLOYED STENT WERE CONFIRMED ON ANALYSIS. THE DAMAGE WAS DETERMINED TO BE PACKAGING RELATED AND THE ABOVE MENTIONED CAPA WAS OPENED TO ADDRESS THIS TYPE OF FAILURE IN THE SMART CONTROL FAMILY OF DEVICES.

    Description of Event or Problem · 1

    WHEN THE PACKAGE WAS OPENED, 10MM-12MM FROM THE DISTAL TIP WAS FOUND KINKED. THE PROTECTOR OF PACKAGE CAME OFF, AND THE CATHETER SHAFT WAS EXPOSED. CONSEQUENTLY, THIS DEVICE WAS NOT CLINICALLY USED. THE DEVICE WAS RECEIVED FOR ANALYSIS AND AFTER REVIEW, PARTIAL PREMATURE DEPLOYMENT OF THE STENT WAS IDENTIFIED. THEREFORE, THIS FILE WAS REDETERMINED TO BE REPORTABLE BASED ON SIGNIFICANT ANALYSIS FINDINGS AND FOLLOW-UP INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS NIM CORDIS DE MEXICO NA 13164942

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK