BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1844914 · Received September 27, 2010

    Report

    Report Number
    9616099-2010-00720
    Event Type
    Injury
    Date Received
    September 27, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K042969
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 14022736 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION. HOWEVER, THE ENGINEERING ANALYSIS IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT WHEN DEPLOYING THE STENT IT DISLODGED AND MISSED THE TARGET LOCATED IN THE ILIAC VEIN. THE STENT WAS POST DILATED AND LEFT IN PLACE. THE LESION DIAMETER WAS 12-13MM AND 3 CM IN LENGTH. AN 8F TERUMO SHEATH WAS USED, NO GUIDING CATHETER WAS USED. THE VEIN WAS NOT SIGNIFICANT WITH STENOSIS AND HAD NO CALCIFICATION, TORTUOUSITY OR ACUTE BENDS. DELIVERY WAS IPSILATERAL. DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE SDS BECAUSE OF THROMBUS LOCATED PROXIMAL TO THE TARGET SITE. NO UNUSUAL FORCE WAS USED. THERE WAS NO PROBLEM PREPPING THE DEVICE. THE ANALYSIS OF THE RETURNED PRODUCT SHOWED THAT THE STENT WAS STILL INTACT ON THE STENT DELIVERY SYSTEM. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CLARIFY THE ISSUE BUT NO ANSWERS HAVE BEEN PROVIDED. ONE NON-STERILE UNIT OF SMART CONTROL 14 X 40 MM WAS RECEIVED COILED IN A PLASTIC BAG. LOCKING PIN AND STENT WERE AT THE CORRECT POSITION. OUTER MEMBER WAS KINKED AT 3.9 CM AND BENT AT 10.5CM FROM ID BAND. BLOOD RESIDUES WERE FOUND ON WIRE LUMEN. USABLE LENGTH WAS MEASURED AGAINST DRAWING, THE DIMENSION WAS WITHIN SPECIFICATION. STENT DEPLOYMENT PROCESS WAS PERFORMED SUCCESSFULLY WITH NO RESISTANCE FELT. 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 "DEPLOYMENT DIFFICULTY-PREMATURE DEPLOYMENT" CONDITION WAS NOT CONFIRMED SINCE THE STENT WAS AT THE CORRECT POSITION, HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED, CONTROLS EXIST IN THE MANUFACTURING PROCESS TO PREVENT THIS FAILURE AS WELL AS THERE ARE INSPECTIONS TO DETECT THIS TYPE OF FAILURE, PROCEDURAL FACTORS MAY CONTRIBUTE TO FAILURE AS REPORTED. THE KINK / BEND CONDITION FOUND DURING THE ANALYSIS COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER IT COULD BE RELATED TO THE COILED CONDITION OF THE UNIT RECEIVED FOR ANALYSIS. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE CONDITION REPORTED BY THE CUSTOMER IS MANUFACTURING RELATED, THEREFORE NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE STENT DISLODGED WHILE IT WAS DEPLOYED.

    Description of Event or Problem · 1

    ADDENDUM RECEIVED 9/29/2010: THERE WAS NO PROBLEM PREPPING THE DEVICE. THE TARGET LESION WAS THE ILIAC VEIN. THE LESION DIAMETER WAS 12-13MM. AN 8F TERUMO SHEATH WAS USED. NO GUIDING CATHETER WAS USED. VESSEL LENGTH WAS 3CM. THE VEIN WAS NOT SIGNIFICANT WITH STENOSIS AND HAD NO CALCIFICATION, TORTUOUSITY OR ACUTE BENDS. DELIVERY WAS IPSILATERAL. DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE SDS BECAUSE OF THROMBUS. NO UNUSUAL FORCE WAS USED. THE THROMBUS WAS PROXIMAL TO THE TARGET LESION. VISPAQUE CONTRAST WAS USED AND MIXED WITH NORMAL SALINE (RATIO UNKNOWN). THE SDS WAS ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION. THE STENT DISLODGED AND JUST MISSED THE TARGET. THEREFORE THE STENT WAS NOT RETRIEVED AND POST-DILATED WITH A 12MM BALLOON AT 10ATM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA 14022736

    Patients

    Seq Age Sex Outcome Treatment
    1