BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2091681 · Received May 17, 2011

    Report

    Report Number
    9616099-2011-00336
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 3, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: 6 FR COOK SHEATH INTRODUCER AND UNIDENTIFIED SECOND STENT. AFTER PRE-DILATING A HEAVILY CALCIFIED 100% OCCLUDED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY THAT HAD RECOILED THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN ADVANCING THE STENT DELIVERY SYSTEM (SDS). AS HE PUSHED THE SDS HE NOTICED THE DISTAL END OF THE STENT HAD BEEN UNCOVERED. HE REMOVED THE SDS, DILATED THE LESION AGAIN AND USED A 2ND STENT TO COMPLETE THE PROCEDURE. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION AND WAS NOT REMOVED BEFORE ATTEMPTING DEPLOYMENT. THE PHYSICIAN WAS NOT ABLE TO GO PAST THE LESION AND SO THE SDS WAS NOT ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION PRIOR TO STENT DEPLOYMENT AS SPECIFIED IN THE IFU. THE USER HELD THE HANDLE OF THE SMART CONTROL SDS FLAT AND STRAIGHT OUTSIDE THE PATIENT. 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 15335277 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 15335277. OUTER MEMBER SUBASSEMBLY LOT 15327126 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 15324623 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). 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.

    Description of Event or Problem · 1

    WHEN USING A 6X30MM ILIAC SMART CONTROL STENT THROUGH A 100% OCCLUDED LESION IN THE MID SFA THAT HAD BEEN PREDILATED BUT HAD RECOILED, THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN ADVANCING THE DEVICE. AS HE PUSHED, HE NOTICED THE DISTAL END OF THE STENT HAD BEEN UNCOVERED. HE REMOVED THIS STENT, BALLOONED THE LESION AGAIN AND USED A 2ND STENT WITH NO PROBLEM. THE PATIENT WAS UNHARMED AND HAD A NICE RESULT. THE LESION WAS HEAVILY CALCIFIED, 20MM IN LENGTH IN A 4.8MM VESSEL DIAMETER. A 6 FR COOK SHEATH INTRODUCER WAS USED IN THE PROCEDURE AND DELIVERY OF THE SDS TO THE LESION WAS CONTRALATERAL. THE DIAMETER OF THE UNCONSTRAINED STENT SIZE WAS 1-2 MM LARGER THAN THE VESSEL DIAMETER. THE STENT DELIVERY SYSTEM DID NOT PASS THROUGH ANY ACUTE BENDS. THROMBUS WAS NOT PRESENT PROXIMAL TO, AT, OR DISTAL TO THE LESION SITE. AFTER PRE-DILATATION THE PERCENTAGE OF STENOSIS WAS 90%. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION AND WAS NOT REMOVED BEFORE ATTEMPTING TO DEPLOY THE SMART CONTROL STENT. THE PHYSICIAN WAS NOT ABLE TO GO PAST THE LESION AND SO THE SDS WAS NOT ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION PRIOR TO STENT DEPLOYMENT. THE USER HELD THE HANDLE OF THE SMART CONTROL SDS FLAT AND STRAIGHT OUTSIDE 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 15335277

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR