BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 3872778 · Received June 13, 2014

    Report

    Report Number
    9616099-2014-00382
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW AND ADDITIONAL INFORMATION ARE PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THE GENDER OF THE PATIENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. COMPLAINT CONCLUSION: WHILE DEPLOYING A STENT TO THE LEFT SUPERFICIAL FEMORAL ARTERY IT WAS REPORTED THAT THE STENT JUMPED FORWARD APPROXIMATELY 1 CM LEAVING THE PROXIMAL PORTION OF THE LESION UNCOVERED. AN ADDITIONAL STENT WAS IMPLANTED TO FULLY COVER THE LESION. THERE WAS NO REPORTED PATIENT INJURY. THE LESION LENGTH AND REFERENCE DIAMETER ARE UNKNOWN. THE LESION HAD AN 80% STENOSIS AND IT IS UNKNOWN IF THE LESION WAS CALCIFIED OR IF THE VESSEL WAS TORTUOUS. THERE WAS NO THROMBUS PRESENT PROXIMAL TO, AT, OR DISTAL TO THE LESION. THERE WERE NO DAMAGES OR ANOMALIES NOTED TO THE 7X60MM SMART CONTROL STENT DELIVERY SYSTEM (SDS) OR PACKAGING PRIOR TO USE. THE DEVICE WAS HANDLED AND PREPPED ACCORDING TO THE IFU. A CONTRALATERAL APPROACH WAS FROM THE RIGHT FEMORAL ARTERY. IT IS UNKNOWN IF THE LESION WAS PRE-DILATED. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE TO THE VESSEL OR CROSSING THE LESION, THE SDS DID NOT PASS THROUGH ANY ACUTE BENDS NOR DID IT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. DURING ADVANCEMENT THE LOCKING PIN WAS IN PLACE AND WAS REMOVED BEFORE ATTEMPTING TO DEPLOY THE STENT. WHEN THE SDS WAS DELIVERED TO THE TARGET LESION THE STENT JUMPED FORWARD APPROXIMATELY 1 CM LEAVING THE PROXIMAL PORTION OF THE LESION UNCOVERED. THERE WAS NO DIFFICULTY DEPLOYING THE STENT. THE HANDLE OF THE SMART CONTROL SDS WAS FLAT AND STRAIGHT OUTSIDE THE PATIENT. THE SDS WAS EASILY REMOVED FROM THE PATIENT. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. REVIEW OF LOT 15965929 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. IT IS POSSIBLE THAT THE OPERATOR'S INTERACTION WITH THE SDS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT IF THE DEPLOYMENT STEPS AS LISTED IN THE IFU WERE NOT FOLLOWED CORRECTLY. WITH THE INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. WITH REVIEW OF THE DEVICE HISTORY RECORDS, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE MANUFACTURING PROCESS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE AFFILIATE, THE STENT JUMPED FORWARD APPROXIMATELY 1CM, SO THE PROXIMAL LESION WAS NOT COVERED. ANOTHER STENT WAS IMPLANTED TO FULLY COVER THE LESION. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF A TARGET LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION LENGTH AND REFERENCE DIAMETER ARE UNKNOWN. THE LESION HAD 80% STENOSIS. IT IS UNKNOWN IF THE LESION WAS CALCIFIED OR IF THE VESSEL WAS TORTUOUS. THERE WAS NO THROMBUS PRESENT PROXIMAL TO, AT, OR DISTAL TO THE LESION. FOR THE PROCEDURE, A 7X60MM SMART CONTROL STENT DELIVERY SYSTEM (SDS) WAS OPENED. THERE WERE NO DAMAGES OR ANOMALIES NOTED TO THE DEVICE OR PACKAGING PRIOR TO USE. THE DEVICE WAS HANDLED AND PREPPED ACCORDING TO THE IFU. A CONTRALATERAL APPROACH WAS FROM THE RIGHT FEMORAL ARTERY. IT IS UNKNOWN IF THE LESION WAS PRE-DILATED. A 7X60MM SMART CONTROL STENT WAS INSERTED INTO THE PATIENT. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE TO THE VESSEL OR CROSSING THE LESION. THE SDS DID NOT PASS THROUGH ANY ACUTE BENDS. THE SDS DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. DURING ADVANCEMENT THE LOCKING PIN WAS IN PLACE AND WAS REMOVED BEFORE ATTEMPTING TO DEPLOY THE STENT. WHEN THE SDS WAS DELIVERED TO THE TARGET LESION, THE STENT WAS DEPLOYED. BUT THE STENT JUMPED FORWARD APPROXIMATELY 1CM, SO THE PROXIMAL LESION COULD NOT BE COVERED. THERE WAS NO DIFFICULTY DEPLOYING THE STENT AND UNUSUAL FORCE HAD NOT APPLIED DURING ADVANCEMENT. THE HANDLE OF THE SMART CONTROL SDS WAS FLAT AND STRAIGHT OUTSIDE THE PATIENT. THE SDS WAS EASILY REMOVED FROM THE PATIENT. THE DEVICE DID NOT KINK/BEND ANY TIME DURING THE PROCEDURE AND WAS NOT USED WITH OTHER DEVICES THAT WERE KINKED/BENT. AN ADDITIONAL STENT (7X40MM SMART CONTROL) WAS PLACED DISTALLY TO THE 1ST SMART CONTROL STENT AND THE ENTIRE LESION WAS FULLY COVERED. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350165 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 15965929

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7X40MM SMART CONTROL STENT