BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2982621 · Received February 28, 2013

    Report

    Report Number
    9616099-2013-00099
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 8, 2013
    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

    COMPLAINT CONCLUSION: DURING AN INTERVENTIONAL ENDOVASCULAR PROCEDURE THE POWERFLEX P3 BALLOON CATHETER USED FOR PRE-DILATION RUPTURED AT 7 ATMOSPHERES. ALSO, DURING DEPLOYMENT OF A SMART CONTROL STENT, THE STENT JUMPED 2 TO 3 CM DISTALLY FROM THE INTENDED POSITION ONLY COVERING ONE HALF OF THE LESION. AN ADDITIONAL STENT WAS REQUIRED TO COVER THE PROXIMAL PORTION OF THE LESION. THERE WAS NO PATIENT INJURY REPORTED. THE TARGET LESION WAS FROM THE RIGHT COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. THE TARGET LESION WAS REPORTED TO BE HEAVILY CALCIFIED AND SLIGHTLY TORTUOUS WITH A 90% STENOSIS. THE APPROACH WAS MADE FROM THE FEMORAL ARTERY. A GUIDEWIRE CROSSED THE ILIAC BIFURCATION AND THEN THE LESION FOLLOWED BY A POWERFLEX P3 FOR PRE-DILATION, HOWEVER, THE BALLOON RUPTURED WHILE IT WAS BEING INFLATED AT 7 ATMOSPHERES. THE POWERFLEX P3 WAS EXCHANGED FOR A DIFFERENT BALLOON CATHETER TO COMPLETE PRE-DILATION. IT IS LIKELY THAT THE SMART CONTROL/SDS WAS TRAPPED BECAUSE THE LESION WAS CALCIFIED AND CAUSED THE STENT TO JUMP FORWARD RESULTING IN THE INACCURATE STENT PLACEMENT. THE SMART CONTROL LOCKING PIN WAS NOTED TO BE IN PLACE DURING ADVANCEMENT OF THE STENT DELIVERY SYSTEM/SDS. THE LOCKING PIN WAS REMOVED BEFORE ATTEMPTING TO DEPLOY THE STENT. THE SDS WAS ADVANCED PAST THE LESION AND THEN DRAWN BACK INTO THE LESION PRIOR TO ATTEMPTING STENT DEPLOYMENT. THE HANDLE OF THE SDS WAS HELD FLAT AND STRAIGHT OUTSIDE THE PATIENT FOR DEPLOYMENT. IT WAS NOT KNOWN IF THERE WAS STENT OVERLAP AFTER PLACEMENT OF THE SECOND STENT. THE ADDITIONAL STENT EXPANDED FULLY WITH GOOD WALL APPOSITION AND WAS POST-DILATED. THERE WAS NO THROMBUS NOTED POST-DEPLOYMENT. THE PROCEDURE WAS FINISHED SUCCESSFULLY. BOTH COMPLAINT PRODUCTS WERE INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE COMPLAINT PRODUCTS WERE PREPPED PROPERLY ACCORDING TO THE IFU WITH NO PROBLEMS NOTED. THERE WAS NO REPORTED PATIENT INJURY. (B)(4): 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. REVIEW OF LOT 15619655 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. WITH THE LIMITED AMOUNT OF 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 BALLOON BURST AND INACCURATE STENT DEPLOYMENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. THIS IS ONE OF TWO PRODUCTS USED FOR THE SAME PROCEDURE/PATIENT. THE OTHER PRODUCT ((B)(4)) IS BEING REPORTED VIA ASR REPORTING.

    Additional Manufacturer Narrative · 1

    INFLATION DEVICE: ENCORE; GW: RADIFOCUS; YCONNECTOR: GOODTEC; BC: CONQUEST; SHEATH: PARENT; STENT:LUMINEXX 10/30MM. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED FOR THE SAME PROCEDURE/PATIENT. THE OTHER PRODUCT (SR#1-1047705667, (B)(4)) IS BEING REPORTED VIA (B)(4) REPORTING.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE POWERFLEX P3 5.0 X 20 BALLOON CATHETER/BC USED FOR PRE-DILATION RUPTURED A 7 ATM. AFTERWARDS, SMART CONTROL (10/40MM 80CM: COMPLAINT PRODUCT) WAS DELIVERED TO THE LESION, BUT THE STENT JUMPED 2 TO 3 CM DISTALLY FROM THE INTENDED POSITION, AND THE STENT COVERED HALF PORTION OF THE LESION. THEREFORE, AN ADDITIONAL STENT (LUMINEXX 10/30MM) WAS REQUIRED TO BE COVERED THE PROXIMAL LESION (REST OF THE HALF PORTION OF THE LESION). THEN, IT WAS PLACED AT THE PROXIMAL PORTION OF THE LESION. THERE WAS NO PATIENT'S INJURY REPORTED, AND THE PRODUCTS WILL NOT BE RETURNED FOR ANALYSIS. APPROACH WAS MADE FROM THE FEMORAL ARTERY, AND A GUIDEWIRE (RADIFOCUS .035INCH) CROSSED THE ILIAC BIFURCATION, AND IT CROSSED THE LESION. POWERFLEX P3 (5.0/20MM: COMPLAINT PRODUCT) WAS DELIVERED TO THE LESION FOR PRE-DILATION, BUT THE BALLOON RUPTURED WHILE IT WAS BEING INFLATED AT 7ATM. THEREFORE, THE POWERFLEX P3 WAS EXCHANGED FOR A DIFFERENT BALLOON CATHETER (CONQUEST ) WAS USED INSTEAD FOR PRE-DILATION. THE PROCEDURE WAS FINISHED SUCCESSFULLY. IT IS LIKELY THAT THE SDS WAS TRAPPED BECAUSE THE LESION WAS CALCIFIED AND CAUSED THE INACCURATE STENT PLACEMENT. THE PATIENT WAS A (B)(6) MALE. PTA (STENTING): THE TARGET LESION WAS FROM THE RIGHT COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. IT IS UNKNOWN IF THE LESION WAS A DE NOVO, BUT WAS HEAVILY CALCIFIED AND SLIGHTLY TORTUOUS. THERE WAS 90% STENOSIS AT THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87786 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 15619655

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention