BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2144269 · Received June 29, 2011

    Report

    Report Number
    9616099-2011-00454
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: BALLOON: POWERFLEX P3, 8X40MM. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 15234676 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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. 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 EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    STENT PLACEMENT: THE TARGET LESION WAS FROM THE LEFT COMMON ILIAC ARTERY TO EXTERNAL ILIAC ARTERY. THE PATIENT WAS FEMALE BUT AGE WAS UNKNOWN. MODERATE CALCIFICATION AND VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS 60%. IPSILATERAL APPROACH. A GUIDEWIRE (PRODUCT: RADIFOCUS, BRAND: TERUMO, 0.035INCH) WAS INSERTED ACROSS THE LESION AND SMART CONTROL (CATALOGUE#: C10060SL, LOT#: 15234676, COMPLAINT PRODUCT) WAS DELIVERED TO THE LESION. THE STENT PLACEMENT WAS STARTED USING THE DIAL (NOT USING THE LEVER); HOWEVER, THE STENT JUMPED TOWARD THE AORTA AND THE STENT HIT THE AORTA WALL AND STOPPED THERE. 20-30MM OF THE DISTAL END OF THE STENT WAS PLACED INSIDE THE AORTA. POST-DILATATION OF THE STENT WAS CONDUCTED USING THE BALLOON CATHETER (PRODUCT: POWERFLEX P3, 8MM X 40MM). THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. THERE WAS NO BLOCKING OF BLOOD FLOW AND PATIENT'S CONDITION IS STABLE. NO PRODUCT RETURN. PHYSICIAN'S COMMENT: IT IS STRANGE THAT THE ENTIRE LENGTH OF THE STENT (60MM) WAS DEPLOYED USING ONLY THE DIAL, ALTHOUGH IT IS NECESSARY TO USE THE LEVER TO DEPLOY THE STENT MORE THAN 40MM. THE SUPPORTING DOCTOR MIGHT HAVE HELD THE SHAFT OF THE SMART CONTROL DURING THE DEPLOYMENT OF THE STENT.

    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 15234676

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDEWIRE:TERUMO 0.035INCH