BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2152924 · Received July 7, 2011

    Report

    Report Number
    9616099-2011-00468
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 9, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 15296090 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. AN EXCURSION WAS FOUND FOR LOT 15296090 DUE TO AN UCL OUT OF CONTROL POINT FOR THE GRAPHIC OF SMART CONTROL MDX YIELD. SINCE THE EXCURSION WAS AT FAVORABLE SIDE OF THE SPECIFICATION NO ACTIONS WERE TAKEN. OUTER MEMBER SUBASSEMBLY LOT 15287149 WAS REVIEWED. IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCE WAS GENERATED AND NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE CATHETER TIP FUSING PARAMETERS AND FPI/LPI PULL TEST RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND. THE OPERATOR QUALIFICATION RECORDS FOR FUSING OPERATION WERE REVIEWED. THE OPERATORS THAT PERFORMED THIS OPERATION WERE QUALIFIED ON THE APPROPRIATE MANUFACTURING WORK INSTRUCTION REVISION AT THE TIME OF THE LOT MANUFACTURING. CALIBRATION RECORDS FOR FUSING MACHINE WERE REVIEWED, AND IT WAS FOUND THAT THE EQUIPMENT / TOOL WERE CALIBRATED IN A TIMELY MANNER. THE LOT INVOLVED IN THE COMPLAINT WAS MANUFACTURED WITHIN THE CALIBRATION DATES. PREVENTIVE MAINTENANCE RECORDS FOR FUSING MACHINE WERE REVIEWED, AND IT WAS FOUND THAT THE PREVENTIVE MAINTENANCE WAS EXECUTED DURING THE ESTABLISHED TIME PERIOD. THE LOT INVOLVED IN THE COMPLAINT WAS MANUFACTURED WITHIN THE PREVENTIVE MAINTENANCE DATES. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN PLACED A SMART CONTROL STENT IN THE ILIAC ARTERY. THE SAME PHYSICIAN BROUGHT THE PATIENT BACK TO OPERATING ROOM FOR A SCHEDULED FEM-POP BYPASS APPROXIMATELY 10 DAYS AFTER THE SMART STENT WAS PLACED IN THE ILIAC ARTERY. WHEN THE PHYSICIAN OPENED THE ARTERY AT THE FEMORAL LEVEL, HE SAW A FOREIGN BODY THAT WAS ALL THE WAY INTO THE STENT. HE REMOVED IT WITHOUT INCIDENT, AND THE STENT REMAINED WIDELY PATENT. THE OBJECT REMOVED WAS APPROXIMATELY 4 INCHES IN LENGTH AND APPEARED TO BE PART OF THE DEPLOYMENT SHEATH OF THE STENT. IT WAS LIGHT BLUE IN COLOR. THERE WAS NO HARM TO THE PATIENT. A VISIT TOOK PLACE ON (B)(6) 2011 AT THE (B)(6) HOSPITAL BY A CORDIS DE MEXICO QUALITY ENGINEER REPRESENTATIVE IN ORDER TO ANALYZE A FOREIGN BODY THAT WAS FOUND IN PATIENT DURING A SCHEDULED FEM-POP BYPASS (AFTER 10 DAYS OF A STENT PROCEDURE). DURING VISUAL ANALYSIS THE FOLLOWING WAS OBSERVED: AN UNKNOWN NON STERILE PLASTIC STRIP OF BLUE COLOR OF 8.5 INCHES OF LENGTH WAS RECEIVED AT THE (B)(6) HOSPITAL FOR ANALYSIS IN A PLASTIC CONTAINER. ELONGATIONS OF .125 INCHES AND 2.4 INCHES WERE FOUND AT 3.2 INCHES AND AT 4.83 INCHES RESPECTIVELY FROM DISTAL END "A." DAMAGES AND TWISTING CHARACTERISTICS WERE DETECTED THROUGHOUT THE PLASTIC SEGMENT. CUTTING CHARACTERISTICS APPEARS TO BE THROUGHOUT THE STRIP LENGTH. INNER SIDE OF THE PLASTIC STRIP IS NOT BRAIDED WIRE. DEVICES USED DURING THE STENT PROCEDURE: CORDIS SMART CONTROL, ILIAC 6X80ML; CATALOG C06080ML AND LOT NUMBER 15296090, CORDIS, POWER FLEX BALLOON PTA (UNKNOWN CATALOG AND LOT NUMBER), CORDIS, 8F INTRODUCER CATHETER (UNKNOWN CATALOG AND LOT NUMBER), CORDIS, 0.035 GW (UNKNOWN CATALOG AND LOT NUMBER). PHYSICIAN INFORMATION PROVIDED DURING VISIT: AFTER 10 DAYS OF THE STENT PROCEDURE WHERE THE CORDIS DEVICES WERE USED, THE PHYSICIAN BROUGHT THE PATIENT BACK TO OPERATING ROOM FOR A SECOND SCHEDULED FEM-POP BYPASS. WHEN THE PHYSICIAN OPENED THE ARTERY AT THE FEMORAL, HE SAW A FOREIGN BODY THAT WAS ALL THE WAY INTO THE STENT IMPLANTED IN THE FIRST PROCEDURE (NOTE: DURING THE FEM-POP BYPASS PROCEDURE NO CORDIS PRODUCTS WERE USED). ALL CORDIS DEVICES USED DURING THE STENT PROCEDURE WERE DISCARDED AFTER COMPLETION OF PROCEDURE. PATIENT'S LESION HAD 90% OF STENOSIS. LESION CALCIFICATION AND TORTUOSITY WAS NOT AVAILABLE. NO ANOMALIES WERE NOTED WHEN THE DEVICES WERE REMOVED FROM THE PACKAGE. NO ANOMALIES WERE NOTED DURING PREPARATION. NO RESISTANCE WAS FELT WHILE ADVANCING THE DEVICE. NO EXCESSIVE TORQUING WAS REQUIRED. THE STENT DEPLOYMENT WAS SMOOTH AND WITHOUT DISCREPANCIES. NO RESISTANCE WAS FELT WHILE WITHDRAWING THE DEVICE. NO PHOTOS/VIDEOS OF THE PROCEDURAL ARE AVAILABLE. NO ADVERSE EVENT WAS PRESENTED BY THE PATIENT. BASED THAT THE COLOR OF THE PLASTIC STRIP DOES NOT MATCH WITH THE SMART CONTROL OUTER SHEATH COLOR AND THAT THE LUMEN SIDE IS NOT BRAID WIRE PRESENT; IT CAN BE CONCLUDED THAT THE BLUE STRIP DOES NOT BELONG TO THE SMART CONTROL OUTER SHEATH, THEREFORE THE CUSTOMER COMPLAINT REPORTED BY THE CUSTOMER "SES CATHETER TIP SEPARATED-IN PATIENT" COULD NOT BE CONFIRMED. THE SOURCE OF THE BLUE STRIP AND THE CAUSE OF THE SEPARATION IN PATIENT COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS DUE TO THE LACK OF EVIDENCE (DEVICES INVOLVED WITH THE STENT PROCEDURE NOT AVAILABLE AND NO POSSIBLE TO PERFORM ADDITIONAL SEM AND FTIR ANALYSES TO THE PLASTIC STRIP); HOWEVER IT DOES NOT APPEARS TO BE MANUFACTURING RELATED, SINCE THERE ARE NOT DEVICES' DISCREPANCIES REPORTED BY THE PHYSICIAN DURING THE STENT PROCEDURE. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED MAY HAVE BEEN CAUSED BY A NON-CORDIS DEVICE AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE INVOLVING THE SMART CONTROL STENT DELIVERY SYSTEM.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN PLACED SMART STENT IN THE ILIAC ARTERY. THE SAME PHYSICIAN BROUGHT THE PATIENT BACK TO OPERATING ROOM FOR A SCHEDULED FEM-POP BYPASS. WHEN THE PHYSICIAN OPENED THE ARTERY AT THE FEMORAL, HE SAW A FOREIGN BODY THAT WAS ALL THE WAY INTO THE STENT. HE REMOVED IT WITHOUT INCIDENT, AND THE STENT REMAINED WIDELY PATENT. THE OBJECT REMOVED WAS APPROXIMATELY 4 INCHES IN LENGTH AND APPEARED TO BE PART OF THE DEPLOYMENT SHEATH OF THE STENT. IT WAS LIGHT BLUE IN COLOR. THERE WAS NO HARM TO THE PATIENT.

    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 15296090

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R