BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2111236 · Received June 2, 2011

    Report

    Report Number
    9616099-2011-00374
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 2, 2011
    Report Date
    June 29, 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

    WHILE DEPLOYING A STENT IN THE RIGHT EXTERNAL ILIAC ARTERY IT WAS REPORTED THAT THE STENT JUMPED FORWARD REQUIRING PLACEMENT OF AN ADDITIONAL STENT PROXIMAL TO THE LESION. THE VESSEL HAD MODERATE CALCIFICATION AND VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS 80%. THERE WAS NO REPORTED PATIENT INJURY. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 15145362 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.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    WHILE DEPLOYING A STENT IN THE RIGHT EXTERNAL ILIAC ARTERY IT WAS REPORTED THAT THE STENT JUMPED FORWARD REQUIRING PLACEMENT OF AN ADDITIONAL STENT PROXIMAL TO THE LESION. THE VESSEL HAD MODERATE CALCIFICATION AND VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS 80%. THERE WAS NO REPORTED PATIENT INJURY. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 15145362 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 CHARACTERIST.

    Description of Event or Problem · 1

    THE PATIENT WAS MALE BUT AGE WAS UNKNOWN. THE TARGET LESION WAS THE RIGHT EXTERNAL ILIAC ARTERY. THERE WAS MODERATE CALCIFICATION AND VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS 80%. IPSILATERAL APPROACH WAS TAKEN FOR THE PROCEDURE. A SMART CONTROL ILIAC 6X60 (COMPLAINT PRODUCT) WAS DELIVERED TO THE TARGET LESION. HOWEVER, THE STENT JUMPED FORWARD DURING DEPLOYMENT. AN ADDITIONAL STENT (DETAILS UNK) WAS PLACED PROXIMAL TO THE INITIAL STENT. THE ENTIRE TARGET LESION WAS FULLY COVERED BY THE STENTS AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. THERE IS NO PRODUCT RETURN.

    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 15145362

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention