BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1133682 · Received August 20, 2008

    Report

    Report Number
    9616099-2008-02040
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 23, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    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 WAS PREMATURELY DEPLOYED DURING AN INTERVENTIONAL PROCEDURE. THERE WAS NO REPORTED PATIENT SPECIFIC INFORMATION REPORTED. THE TARGET LESION WAS RIGHT EXTERNAL ILIAC ARTERY DESCRIBED AS MILDLY CALCIFIED, MODERATELY TORTUOUS AND 99% STENOTIC. BRACHIAL APPROACH WAS PERFORMED, AND THE TARGET LESION WAS PREDILATED. THE DEVICE PREP AND HANDLING WERE PERFORMED ACCORDING TO THE IFU (INSTRUCTIONS FOR USE). THE SMART CONTROL STENT ON SDS (STENT DELIVERY SYSTEM) WAS INTRODUCED AND TRACKED THROUGH THE AORTA, TOWARDS THE ETERNAL ILIAC ARTERY, THE PHYSICIAN NOTED THAT THE STENT WAS EXPOSED APPROXIMATELY 1CM FROM THE TIP. THE PORTION OF THE STENT THAT WAS EXPOSED WAS PARTIALLY DEPLOYED. AT THIS POINT, THE LOCKING PIN WAS STILL IN THE INITIAL POSITION. THE SHAFT WAS PULLED BACK CAREFULLY AND THE SDS WAS REMOVED FROM THE PATIENT WITH THE SHEATH. THERE WAS NO PATIENT INJURY REPORTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOG PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 13284833 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THREE UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. SUBASSEMBLY DHR REVIEW: OUTER MEMBER SUBASSEMBLY LOT 13283309 WAS REVIEWED. IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCES WERE GENERATED AND NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. NONCONFORMANCES: NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. WITHOUT THE RETURN OF THE PRODUCT THE COMPLAINT OF PREMATURE DEPLOYMENT COULD NOT BE CONFIRMED. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR A PROCEDURE IN 2008 WITH A 99%, MILDLY CALCIFIED LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. IT WAS NOTED THAT THE VESSEL WAS MODERATELY TORTUOUS. BRACHIAL APPROACH WAS CHOSEN FOR THE PROCEDURE. THE LESION WAS PRE-DILATED AND AN ATTEMPT WAS MADE TO DELIVER A SMART CONTROL NITINOL STENT. WHEN THE STENT DELIVERY SYSTEM (SDS) WAS ADVANCING THROUGH THE AORTA, TOWARDS THE ETERNAL ILIAC ARTERY, IT WAS NOTED THAT THE STENT WAS EXPOSED APPROXIMATELY 1CM FROM THE TIP AND RELEASED. AT THIS POINT, THE LOCKING PIN WAS NOT REMOVED YET AND IT WAS STILL IN ITS INITIAL POSITION. THE SHAFT WAS PULLED BACK CAREFULLY AND THE SDS WAS REMOVED FROM THE PATIENT WITH THE SHEATH. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 13284833

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK AMIIA BALLON CATHETER| THE PROCEDURE: A DEJA-VU GUIDEWIRE| 7F SHUTTLE SHEATH| THE FOLLOWING PRODUCT WERE USED DURING| AMPLAZ GUIDE