BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2080311 · Received May 6, 2011

    Report

    Report Number
    9616099-2011-00305
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT YET BEEN RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND:REVIEW OF LOT 15312485 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. NO EXCURSIONS WERE FOUND FOR LOT 15312485. OUTER MEMBER SUBASSEMBLY LOT 15308010 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. COATED POLYIMIDE WIRE LUMEN ASSEMBLY LOT 15297497 WAS REVIEWED IT WAS OBSERVED DURING REVIEW OF THIS LOT THAT NO NONCONFORMANCE WAS GENERATED AND NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND THE ANALYSIS WAS COMPLETED. IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS THE LESION BECAUSE THE DISTAL TIP OF THE SDS BECAME CAUGHT IN THE CALCIFIED VESSEL WALL PROXIMAL TO THE LESION SITE. THE SDS WAS REMOVED FROM THE PATIENT TOGETHER WITH THE 6FR TERUMO SHEATH INTRODUCER. THE SHEATH INTRODUCER WAS INSERTED INTO THE PATIENT AGAIN AND WHEN THE PHYSICIAN PERFORMED ANGIOGRAPHY, THE PHYSICIAN NOTICED THAT THE SMART CONTROL STENT HAD DEPLOYED FROM THE RIGHT TO THE LEFT ILIAC ARTERY. POST DILATION OF THE STENT WAS REQUIRED TO ACHIEVE WALL APPOSITION. THE LOCKING PIN WAS IN PLACE AND WAS NOT REMOVED DURING ADVANCEMENT TOWARDS THE LESION. THE PHYSICIAN FELT THE STENT MIGHT HAVE BEEN RELEASED BECAUSE OF ELONGATION OF THE INNER SHAFT DURING THE REMOVAL OF THE SDS WITH THE DISTAL TIP BEING CAUGHT IN THE CALCIFIED LESION. THERE WAS NO REPORTED PATIENT INJURY. ONE NON-STERILE UNIT OF SMART CONTROL 6F 6X100 MM WAS RECEIVED COILED IN A PLASTIC BAG. STENT WAS NOT RECEIVED; LOCKING PIN WAS AT THE CORRECT POSITION. BLOOD RESIDUES WERE OBSERVED AT BRITE TIP AND AT OUTER SHEATH. NO OTHER ANOMALY WAS DETECTED. THE OUTER DIAMETER (OD) OF THE STENT DELIVERY SYSTEM WAS MEASURED IN SEVERAL PLACES AND IT WAS FOUND WITHIN SPECIFICATION PER DRAWING (B)(4). THE USABLE LENGTH OF THE SDS WAS MEASURED PER DRAWING (B)(4) AND IT WAS FOUND WITHIN SPECIFICATION. DEPLOYMENT ANALYSIS WAS CONDUCTED PER DP (B)(4), WITHOUT THE STENT AND NO RESISTANCE WAS FELT AND NO OTHER ISSUES WERE OBSERVED DURING THE DEPLOYMENT PROCESS. THE CATHETER WAS INTRODUCED INTO A 6FR LAB SAMPLE CATHETER SHEATH INTRODUCER (CSI) INTRODUCER AND NO RESISTANCE WAS FELT (PER DP (B)(4)).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 "STENT WITH INCOMPLETE EXPANSION" CONDITION REPORTED BY THE CUSTOMER COULD NOT BE EVALUATED DUE THE DEVICE WAS RECEIVED WITHOUT STENT. THE "FAILURE TO CROSS" CONDITION REPORTED BY THE CUSTOMER COULD NOT BE EVALUATED DUE TO NATURE OF THE COMPLAINT; HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED OF THE PRODUCT SINCE NO DISCREPANCIES WERE FOUND DURING THE DIMENSIONAL AND FUNCTIONAL ANALYSIS. THE "DEPLOYMENT DIFFICULTY - PREMATURE /IN PATIENT-DURING WITHDRAWAL" COULD NOT BE EVALUATED DUE TO NATURE OF THE COMPLAINT; HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED TO THE PRODUCT SINCE NO DISCREPANCIES WERE FOUND DURING THE DIMENSIONAL AND FUNCTIONAL ANALYSIS WITHOUT THE STENT. CONTROLS ARE IN PLACED AT THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO PREVENT THIS TYPE OF FAILURES, AS WELL AS THERE ARE INSPECTIONS IN PLACE TO DETECT DAMAGES IN THE SDS, REFERENCE PROCEDURES DOCUMENTED IN ROUTE SHEET # (B)(4). HANDLING AND THE COILED CONDITION OF THE UNIT RECEIVED FOR ANALYSIS MAY CONTRIBUTE TO FAILURE AS REPORTED. NEITHER THE DHR REVIEW NOR THE DIMENSIONAL AND FUNCTIONAL ANALYSIS SUGGEST THAT THE CONDITION REPORTED BY THE CUSTOMER IS MANUFACTURING RELATED; THEREFORE, NO ACTIONS WILL BE TAKEN AT THIS TIME. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY THE OPERATIONAL CONTEXT OF THE DEVICE AND/OR VESSEL CHARACTERISTICS.

    Description of Event or Problem · 1

    THE SMART CONTROL STENT WAS NOT PLACED IN THE INTENDED POSITION. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS DESCRIBED AS 90% STENOSED WITH HEAVY CALCIFICATION. THE REFERENCE VESSEL WAS MILDLY TORTUOUS. THE LESION WAS PRE-DILATED WITH A BSJ BALLOON CATHETER AND THE SMART CONTROL STENT WAS DELIVERED IN FROM THE LESION, BUT THE PHYSICIAN FELT RESISTANCE AS IF THE DISTAL TIP OF THE SMART CONTROL WAS CAUGHT IN THE CALCIFIED LESION. THE SMART CONTROL STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PATIENT TOGETHER WITH THE 6FR TERUMO SHEATH INTRODUCER. THE SHEATH INTRODUCER WAS INSERTED INTO THE PATIENT AGAIN AND WHEN THE PHYSICIAN PERFORMED ANGIOGRAPHY, THE PHYSICIAN NOTICED THAT THE SMART CONTROL STENT WAS PLACED FROM RIGHT TO LEFT ILIAC ARTERY. THE STENT WAS POST-DILATED WITH A POWERFLEX P3 BALLOON CATHETER; HOWEVER, NOT ENOUGH VESSEL APPOSITION WAS OBTAINED. THE STENT WAS LEFT AND THE PROCEDURE WAS FINISHED. X-RAY VISION WAS SWITCHED OFF DURING REMOVAL OF THE SMART CONTROL SDS WITH THE GUIDING CATHETER. THE PHYSICIAN FELT THE STENT MIGHT BE RELEASED BECAUSE OF THE ELONGATION OF THE INNER SHAFT DURING THE REMOVAL OF THE SMART CONTROL WITH ITS DISTAL TIP CAUGHT IN THE CALCIFIED LESION. THERE WAS NO CONSEQUENCE TO THE PATIENT. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION. THE LOCKING PIN WAS NOT REMOVED BEFORE ATTEMPTING TO DEPLOY THE SMART CONTROL STENT SINCE THE PHYSICIAN HAD NEVER ATTEMPTED TO DEPLOY THE STENT. THE STENT WAS DEPLOYED DURING REMOVAL OF THE SDS. THE SDS COULD NOT CROSS THE LESION. THE ACCESS SITE WAS THE RIGHT FEMORAL ARTERY. THERE WAS NO THROMBUS NOTED AT THE LESION SITE. THE SDS COULD NOT CROSS THE LESION BECAUSE THE DISTAL TIP OF THE SDS WAS CAUGHT IN THE CALCIFIED VESSEL WALL PROXIMAL TO THE LESION SITE. NO FURTHER INFORMATION WAS AVAILABLE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    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 15312485

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 6FR TERUMO SHEATH INTRODUCER, BSJ BALLOON CATHETER