BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 3802236 · Received May 9, 2014

    Report

    Report Number
    9616099-2014-00314
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    January 28, 2014
    Report Date
    January 28, 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

    THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THE GENDER OF THE PATIENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: IT WAS REPORTED BY THE AFFILIATE THAT DURING PREPARATION OF A 6X60 MM SMART CONTROL STENT, THE PHYSICIAN ATTEMPTED TO FLUSH THE DEVICE FROM A FLUSHING PORT AT THE CONTROL HANDLE. HOWEVER, LEAKAGE WAS CONFIRMED FROM THE SLIDER LEVER AT THE HANDLE. THEREFORE, THE PHYSICIAN STOPPED USING IT AND USED ANOTHER NEW SMART WAS USED SUCCESSFULLY. PRELIMINARY DEVICE EVALUATION REVEALED THAT THE DISTAL TIP WAS SPLIT. THE EVENT DID NOT OCCUR DURING PREP. IT IS UNKNOWN IF THIS CONDITION WAS OBSERVED PRIOR TO SHIPMENT. THE INTENDED TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE WILL BE RETURNED FOR EVALUATION. AFTER THE PROCEDURE, THE PHYSICIAN DEPLOYED THE STENT OUTSIDE OF THE PATIENT, SO THE COMPLAINT PRODUCT WILL BE RETURNED WITHOUT THE STENT. THE DEVICE WAS STORED, INSPECTED, PREPPED, AND HANDLED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. NO UNUSUAL FORCE WAS APPLIED WHILE FLUSHING THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. ONE NON-STERILE SMART CONTROL, ILIAC 6X60ML WAS RECEIVED COILED INSIDE A PLASTIC BAG. UNIT WAS DEPLOYED. BRITE TIP WAS DAMAGED. LOCKING PIN WAS NOT RECEIVED. KINK WAS OBSERVED AT 3CM AND 5CM FROM ID BAND. NO OTHER DISCREPANCIES WERE FOUND. DURING MICROSCOPIC ANALYSIS COULD BE OBSERVED THAT BRITE TIP WAS DAMAGED (FRAYED). SDS WAS FLUSHED AND A LEAKAGE WAS OBSERVED AT THE FLUSHING VALVE. SEM RESULTS SHOWED THAT THE BRITE TIP OF ELONGATION AT THE SURROUNDING AREAS OF THE FRAYED AND SEPARATION. ELONGATION IS A COMMON CHARACTERISTIC OF PIECES WHICH WERE STRETCHED/ PULLED UNTIL SEPARATION. STRETCHING/ PULLING COULD HAVE BEEN RELATED TO THESE CHARACTERISTIC. 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. THE CAUSES OF THE "KINK" AND ¿BRITE TIP FRAYED¿ CONDITION FOUND DURING ANALYSIS COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. CONTROLS ARE IN PLACED AT THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO DETECT THESE KIND OF ISSUES. THE FAILURE "FLUSHING VALVE (SMART CONTROL ONLY) LEAKAGE¿ REPORTED BY THE CUSTOMER WAS CONFIRMED, THE CAUSE OF THE FAILURE WAS RELATED TO SUPPLIER MANUFACTURING PROCESS. A RISK ASSESSMENT HAS BEEN INITIATED TO EVALUATE THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING PREPARATION OF A 6X60ML SMART CONTROL STENT, THE PHYSICIAN ATTEMPTED TO FLUSH THE DEVICE FROM A FLUSHING PORT AT THE CONTROL HANDLE. HOWEVER, LEAKAGE WAS CONFIRMED FROM THE SLIDER LEVER AT THE HANDLE. THEREFORE, THE PHYSICIAN STOPPED USING IT AND USED ANOTHER NEW SMART WAS USED SUCCESSFULLY. PRELIMINARY DEVICE EVALUATION REVEALED THAT THE DISTAL TIP WAS SPLIT. THE EVENT DID NOT OCCUR DURING PREP. IT IS UNKNOWN IF THIS CONDITION WAS OBSERVED PRIOR TO SHIPMENT. THE INTENDED TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WILL BE RETURNED FOR EVALUATION. AFTER THE PROCEDURE, THE PHYSICIAN DEPLOYED THE STENT OUTSIDE OF THE PATIENT, SO THE COMPLAINT PRODUCT WILL BE RETURNED WITHOUT THE STENT. THE DEVICE WAS STORED, INSPECTED, PREPPED, AND HANDLED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. NO UNUSUAL FORCE WAS APPLIED WHILE FLUSHING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280878 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 15642766

    Patients

    Seq Age Sex Outcome Treatment
    1