BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2764071 · Received September 28, 2012

    Report

    Report Number
    9616099-2012-00529
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 4, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED AND THEREFORE THE PREVIOUSLY SUBMITTED INFORMATION IN THE FINAL REPORT IS UPDATED TO REFLECT THE ANALYSIS OF THE DEVICE. DURING PTA A PORTION OF A SMART CONTROL STENT DELIVERY SYSTEM BROKE OFF IN THE GUIDE CATHETER. AFTER DEPLOYMENT OF THE SMART CONTROL STENT THE DELIVERY SYSTEM WAS REMOVED. THEN WHEN ADVANCING THE BALLOON CATHETER THROUGH THE GUIDE CATHETER TO DILATE THE LESION THEY NOTED RESISTANCE IN THE GUIDE CATHETER AND THE BALLOON WOULD NOT ADVANCE FORWARD. THE TERUMO HYDROPHILIC GUIDEWIRE WAS REMOVED AND THE DISTAL PART (BLUE) OF THE DELIVERY SYSTEM ALONG WITH A PIECE OF PLASTIC WAS FOUND IN THE GUIDE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. ONE NON STERILE PKG ASSY 10X080 SMART VAS 80CM WAS RECEIVED INSIDE A PLASTIC BAG. ONE BENT WAS OBSERVED AT 13 CM FROM THE ID BAND. THE UNIT WAS DEPLOYED AND THE STENT WAS NOT RECEIVED. THE GUIDEWIRE LUMEN WAS SEPARATED FROM THE OUTER MEMBER; THE SEPARATION WAS AT 110.4CM FROM DISTAL TIP. IT WAS KINKED AT 14 AND 15CM FROM DISTAL END, AND BELOW THE DISTAL TIP. ONE UNKNOWN GUIDEWIRE WAS RECEIVED. BLOOD RESIDUES WERE OBSERVED AT THE DISTAL SECTION OF THE INNER MEMBER. DURING MICROSCOPIC ANALYSIS THE SEPARATED EDGE (WIRE LUMEN) WAS OBSERVED ELONGATED AND IT WAS NOT UNIFORM, IT WAS RIPPED. EVIDENCE OF WIRE LUMEN WAS FOUND IN THE HUB. FUNCTIONAL TEST (INSERTION/WITHDRAWAL) WAS PERFORMED. USING A GUIDE WIRE CORDIS 0.035 (LAB SAMPLE) AND RECEIVED GUIDE WIRE WERE INTRODUCED THROUGH THE UNIT AND NO RESISTANCE/FRICTION WAS FEELING. 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 CAUSE OF 'KINKED CONDITION' 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 THIS KIND OF ISSUES. HANDLING AND PROCEDURAL FACTORS COULD BE CONTRIBUTED TO THIS CONDITION. THE FAILURE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE EXACT CAUSE OF THE REPORTED FAILURE CONDITION COULD NOT BE CONCLUSIVELY DETERMINED. CONTROLS ARE IN PLACED AT THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO DETECT THIS KIND OF ISSUES. HANDLING AND PROCEDURAL FACTORS COULD BE CONTRIBUTED TO THE FAILURE EXPERIENCED BY CUSTOMER. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE FAILURE IS MANUFACTURING RELATED. THEREFORE NO ACTIONS WILL BE TAKEN. WITH THE INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, PER THE ANALYSIS IT APPEARS THAT THE GUIDEWIRE LUMEN HAD BEEN SUBJECTED TO CONSIDERABLE FORCE AS THERE WAS EVIDENCE OF THE MATERIAL BEING RIPPED. PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    DURING PTA A PORTION OF A SMART CONTROL STENT DELIVERY SYSTEM BROKE OFF IN THE GUIDE CATHETER. AFTER DEPLOYMENT OF THE SMART CONTROL STENT THE DELIVERY SYSTEM WAS REMOVED. THEN WHEN ADVANCING THE BALLOON CATHETER THROUGH THE GUIDE CATHETER TO DILATE THE LESION THEY NOTED RESISTANCE IN THE GUIDE CATHETER AND THE BALLOON WOULD NOT ADVANCE FORWARD. THE TERUMO HYDROPHILIC GUIDEWIRE WAS REMOVED AND THE DISTAL PART (BLUE) OF THE DELIVERY SYSTEM ALONG WITH A PIECE OF PLASTIC WAS FOUND IN THE GUIDE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. REVIEW OF LOT 15571186 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. 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 REPORTED EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING PTA A PORTION OF A SMART CONTROL STENT DELIVERY SYSTEM BROKE OFF IN THE GUIDE. THE PHYSICIAN PLACED THE SMART CONTROL STENT AND THEY DID NOT FIND ANY PROBLEM. THEY REMOVED THE DELIVERY SYSTEM OF THE AND WHEN PASSING THE BALLOON THROUGH THE GUIDE TO DILATE THE LESION THEY NOTED RESISTANCE IN THE GUIDE AND THE BALLOON DID NOT MOVE FORWARD. THEY REMOVED THE TERUMO HYDROPHILIC GUIDE AND FOUND THAT IN THE GUIDE WAS RETAINED THE DISTAL PART (BLUE) OF THE DELIVERY SYSTEM AND A PIECE OF PLASTIC. THERE WAS NO DAMAGE TO THE PATIENT. IN ADDITIONALLY TO THE SMART, THE TERUMO HYDROPHILIC GUIDE USED AND THE PART OF THE DELIVERY SYSTEM OF THE SMART WILL BE SHIPPED FOR EVALUATION.

    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 15571186

    Patients

    Seq Age Sex Outcome Treatment
    1