BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMART CONTROL, ILIAC 8X100

    MDR report key: 6216558 · Received December 30, 2016

    Report

    Report Number
    9616099-2016-00822
    Event Type
    Death
    Date Received
    December 30, 2016
    Date of Event
    December 7, 2016
    Report Date
    January 30, 2017
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    UDI-DI
    20705032024256
    PMA / PMN Number
    P020036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT AFTER A SMART CONTROL, ILIAC 8X100 WAS INSERTED AND DEPLOYED IN THE BIFURCATION OF THE INTERNAL ILIAC ARTERY. WITHIN THREE MINUTES DURING A POST-DILATATION, PERFORATION OCCURRED AND THE PATIENT WAS EXPIRED. AN APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY. A NON CORDIS BALLOON CATHETER (6.0*40MM) WAS INSERTED BUT COULD NOT CROSS THE LESION. THEREFORE, ANOTHER NON CORDIS BALLOON CATHETER (4.0*40MM) WAS INFLATED AS A PRE-DILATATION. THE TARGET LESION WAS THE COMMON FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS 100% (CTO). THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AFTER CAREFUL INSPECTION OF THE POUCH LOOKING FOR DAMAGE TO THE STERILE BARRIER, CAREFULLY PEEL OPEN THE POUCH AND EXTRACT THE STENT DELIVERY SYSTEM FROM THE TRAY. EXAMINE THE DEVICE FOR ANY DAMAGE. IF IT IS SUSPECTED THAT THE STERILITY OR PERFORMANCE OF THE DEVICE HAS BEEN COMPROMISED, THE DEVICE SHOULD NOT BE USED. PERFORATION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. VESSELS THAT ARE RESISTANT TO ANGIOPLASTY HAVE A HIGHER RISK OF INTIMAL DISSECTION DURING INTERVENTIONAL PROCEDURES. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. THIS DOES NOT REPRESENT DEVICE MALFUNCTION. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS RESULTS SUGGESTS THAT THE REPORTED FAILURES COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SMART CONTROL, ILIAC 8X100 WAS INSERTED AND DEPLOYED IN THE BIFURCATION OF THE INTERNAL ILIAC ARTERY. WITHIN THREE MINUTES DURING A POST-DILATATION, PERFORATION OCCURRED AND THE PATIENT WAS EXPIRED. AN APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY. A NON CORDIS BALLOON CATHETER (6.0*40MM) WAS INSERTED BUT COULD NOT CROSS THE LESION. THEREFORE, ANOTHER NON CORDIS BALLOON CATHETER (4.0*40MM) WAS INFLATED AS A PRE-DILATATION. THE TARGET LESION WAS THE COMMON FEMORAL ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS 100% (CTO). THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864990 SMART CONTROL, ILIAC 8X100 STENT, ILIAC NIO CORDIS DE MEXICO C08100SL 17471031 20705032024256

    Patients

    Seq Age Sex Outcome Treatment
    1 Death