BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1983380 · Received February 10, 2011

    Report

    Report Number
    9616099-2011-00093
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 1, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING DEPLOYMENT THE SMART STENT JUMPED FORWARD APPROXIMATELY 1CM FROM THE INTENDED TARGET POSITION. THE TARGET LESION WAS THE LEFT EXTERNAL ILIAC ARTERY. VESSEL CALCIFICATION, VESSEL TORTUOSITY, AND THE RATE OF STENOSIS WERE UNKNOWN. THE LENGTH OF THE LESION IS UNKNOWN. APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY. THERE WAS NO DIFFICULTY ACCESSING THE LESION WITH A GUIDEWIRE. THE TARGET LESION WAS PRE-DILATED WITH 6X20 BALLOON CATHETER. A SMART CONTROL 8X40 WAS ADVANCED WITH NO DIFFICULTY AND DEPLOYED AT THE LESION, HOWEVER THE STENT JUMPED FORWARD APPROXIMATELY 1CM FROM THE INTENDED TARGET POSITION. IT WAS NOTED THAT THE PHYSICIAN VERIFIED THAT BOTH THE LEADING AND TRAILING MARKERS WERE PROXIMAL AND DISTAL TO THE STENT PRIOR TO DEPLOYMENT. IT IS UNKNOWN IF THE PHYSICIAN NOTICED WHILE HE WAS IN THE PROCESS OF DEPLOYING THE UNIT THAT THERE WAS A DELAY BEFORE THE STENT EVENTUALLY RELEASED FROM THE SMART CONTROL CATHETER. NO LONGITUDINAL FORCE WAS APPLIED WHEN DEPLOYING THE STENT. IT IS UNKNOWN IF THERE WAS ANY RESISTANCE WHEN DEPLOYING THE STENT. ANOTHER STENT WAS DEPLOYED AND THE ENTIRE TARGET LESION WAS COVERED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE INSTRUCTIONS FOR USE ADVISES THE USER TO "INITIATE STENT DEPLOYMENT BY RETRACTING THE OUTER SHEATH WHILE HOLDING THE INNER SHAFT IN A FIXED POSITION. DEPLOYMENT IS COMPLETE WHEN THE OUTER SHEATH MARKER PASSES THE PROXIMAL INNER SHAFT STENT MARKER." IT IS POSSIBLE THAT THE OPERATOR'S INTERACTION WITH THE SDS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT IF THESE STEPS WERE NOT FOLLOWED CORRECTLY. HOLDING THE OUTER MEMBER DURING DEPLOYMENT MAY RESULT IN THE SUPPORT MEMBER PUSHING THE STENT FORWARD AND COMPRESSING THE STENT. IN ADDITION, MOVING THE HANDLE PROXIMALLY OR DISTALLY AFTER THE STENT ACHIEVES INITIAL WALL APPOSITION MAY RESULT IN STENT COMPRESSION OR ELONGATION. THIS CAN RESULT IN STENT LENGTHS WHICH ARE LONGER OR SHORTER THAN EXPECTED. THERE IS NOT ENOUGH INFORMATION TO DRAW A DEFINITIVE CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT; HOWEVER, VESSEL CHARACTERISTICS OR PROCEDURAL FACTORS MAY HAVE IMPACTED THE EVENT.

    Description of Event or Problem · 1

    DURING DEPLOYMENT OF THE SMART STENT, THE STENT JUMPED FORWARD APPROXIMATELY 1CM FROM THE INTENDED TARGET POSITION. THE PATIENT WAS MALE BUT AGE WAS UNKNOWN. THE TARGET LESION WAS LEFT EXTERNAL ILIAC ARTERY. VESSEL CALCIFICATION, VESSEL TORTUOSITY, AND THE RATE OF STENOSIS WERE UNKNOWN. THE LENGTH OF THE LESION IS UNKNOWN. APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY. THERE WAS NO DIFFICULTY ACCESSING THE LESION WITH A GUIDEWIRE. THE TARGET LESION WAS PRE-DILATED WITH 6X20 BALLOON CATHETER (DETAILS UNK). THE RATE OF RESIDUAL STENOSIS IS UNKNOWN. A SMART CONTROL (SMART CONTROL, ILIAC 8X40, COMPLAINT PRODUCT) WAS ADVANCED WITH NO DIFFICULTY AND DEPLOYED AT THE LESION, BUT THE STENT JUMPED FORWARD APPROXIMATELY 1CM FROM THE INTENDED TARGET POSITION. IT WAS NOTED THAT THE PHYSICIAN VERIFIED THAT BOTH THE LEADING AND TRAILING MARKERS WERE PROXIMAL AND DISTAL TO THE STENT PRIOR TO DEPLOYMENT. IT IS UNKNOWN IF THE PHYSICIAN NOTICED WHILE HE WAS IN THE PROCESS OF DEPLOYING THE UNIT THAT THERE WAS A DELAY BEFORE THE STENT EVENTUALLY RELEASED FROM THE SMART CONTROL CATHETER. NO LONGITUDINAL FORCE WAS APPLIED WHEN DEPLOYING THE STENT. IT IS UNKNOWN IF THERE WAS ANY RESISTANCE WHEN DEPLOYING THE STENT. ANOTHER NEW PRODUCT (DETAILS UNK) WAS USED AND THE ENTIRE TARGET LESION WAS COVERED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY.

    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 15232535

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 6X20 BALLOON CATHETER