BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2032369 · Received March 29, 2011

    Report

    Report Number
    9616099-2011-00209
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 19, 2011
    Report Date
    March 9, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PROCEDURE CD WAS RETURNED FOR REVIEW; HOWEVER, THE REVIEW HAS NOT YET BEEN COMPLETED. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. ONE NON STERILE UNIT OF SMART CONTROL 10X80 MM WAS RECEIVED COILED IN A PLASTIC BAG. LOCKING PIN AND STENT WERE NOT RECEIVED. TIP WAS UNCANNULATED. BLOOD RESIDUES WERE OBSERVED INSIDE WIRE LUMEN. NO OTHER ANOMALIES WERE FOUND. THE DISTANCE BETWEEN THE STOP AND THE PROXIMAL END OF DISTAL TIP WAS MEASURED AND THE RESULT WAS 86.0 MM WHICH IS ENOUGH TO CONTAIN AN 80 MM CRIMPED STENT. CRIMPED STENT SPECIFICATION IS 79.3 MM (+5.5 MM/-3.00 MM) PER (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. REVIEW OF LOTS 15185978 AND 15188714 MANUFACTURED BEFORE AND AFTER COMPLAINT LOT, REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. SINCE THE STENT WAS NOT RECEIVED IT WAS NOT POSSIBLE TO CONFIRM THE "STENT WITH INCORRECT LENGTH - TOO SHORT" REPORTED BY THE CUSTOMER; HOWEVER, THE DISTANCE BETWEEN THE STOP AND THE PROXIMAL END OF DISTAL TIP WAS MEASURED AND THE RESULT WAS 86.0 MM WHICH IS ENOUGH TO CONTAIN A 80 MM CRIMPED STENT. CONTROLS EXIST IN THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO PREVENT THIS TYPE OF FAILURE, AS WELL AS THERE ARE INSPECTIONS IN PLACE TO DETECT IT, (B)(4). PROCEDURAL FACTORS MAY CONTRIBUTE TO FAILURE AS REPORTED. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE CONDITION REPORTED BY THE CUSTOMER COULD BE MANUFACTURING RELATED, THEREFORE NO CORRECTIVE/ PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE PRODUCT SHOULD CONTAIN AN 8CM STENT; HOWEVER, THE PHYSICIAN FELT THAT THE STENT WAS 6CM. IT WAS REPORTED THAT AN 8CM BALLOON WAS TOO LONG FOR THE STENT, BUT A 6CM BALLOON FIT THE STENT, THEREFORE HE FELT THAT THE STENT WAS 2 CM TOO SHORT. SINCE A SHORTER STENT WAS IMPLANTED, THE SURGEON HAD TO IMPLANT ANOTHER STENT. THE PATIENT STATUS WAS REPORTED AS "FINE." 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. (B)(4): ONE NON STERILE UNIT OF SMART CONTROL 10X80 MM WAS RECEIVED COILED IN A PLASTIC BAG. LOCKING PIN AND STENT WERE NOT RECEIVED. TIP WAS UNCANNULATED. BLOOD RESIDUES WERE OBSERVED INSIDE WIRE LUMEN. SEE ATTACHED PICTURES. NO OTHER ANOMALIES WERE FOUND. THE DISTANCE BETWEEN THE STOP AND THE PROXIMAL END OF DISTAL TIP WAS MEASURED AND THE RESULT WAS 86.0 MM WHICH IS ENOUGH TO CONTAIN AN 80 MM CRIMPED STENT. CRIMPED STENT SPECIFICATION IS 79.3 MM (+5.5 MM/-3.00 MM) PER DRAWING (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. REVIEW OF LOTS 15185978 AND 15188714 MANUFACTURED BEFORE AND AFTER COMPLAINT LOT, REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. SINCE THE STENT WAS NOT RECEIVED, IT WAS NOT POSSIBLE TO CONFIRM THE "STENT WITH INCORRECT LENGTH - TOO SHORT" REPORTED BY THE CUSTOMER; HOWEVER, THE DISTANCE BETWEEN THE STOP AND THE PROXIMAL END OF DISTAL TIP WAS MEASURED AND THE RESULT WAS 86.0 MM WHICH IS ENOUGH TO CONTAIN A 80 MM CRIMPED STENT. CONTROLS EXIST IN THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO PREVENT THIS TYPE OF FAILURE, AS WELL AS THERE ARE INSPECTIONS IN PLACE TO DETECT IT, REFERENCE PROCEDURES DOCUMENTED IN ROUTE SHEET # (B)(4). PROCEDURAL FACTORS MAY CONTRIBUTE TO FAILURE AS REPORTED. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE CONDITION REPORTED BY THE CUSTOMER COULD BE MANUFACTURING RELATED, THEREFORE NO CORRECTIVE/ PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER WAS RELATED TO PROCEDURAL FACTORS, VESSEL CHARACTERISTICS AND/OR USER HANDLING. FILM REVIEW FINDINGS: COMPLAINT NO (B)(4) (TWO CASES ARE SUBMITTED FOR REVIEW. CLINICAL INFORMATION IS LIMITED AND, IN FACT, IT IS UNCLEAR WHICH SET OF IMAGES BELONGS TO WHICH EVENT DESCRIPTION.) OBSERVATIONS: A SINGLE CD-ROM CONTAINING MULTIPLE CINE FILES IS SUBMITTED FOR REVIEW. INITIAL IMAGES SHOW BILATERAL COMMON ILIAC ARTERY STENOSIS. BILATERAL FEMORAL ARTERY ACCESS IS OBTAINED. BILATERAL SMART STENTS ARE PLACED. APPARENTLY BOTH STENTS WERE SUPPOSED TO MEASURE 8CM IN LENGTH. AFTER DEPLOYMENT, THE RIGHT ILIAC STENT WAS NOTED TO BE SHORTER THAN THE LEFT. BILATERAL KISSING BALLOON ANGIOPLASTY WAS PERFORMED. THE LENGTH OF THE RIGHT ILIAC STENT IS ESTIMATED AT 6CM. THE LEFT STENT LENGTH IS ESTIMATED AT 8CM. NO UNSUBTRACTED IMAGES OF THE STENT ARE SUBMITTED FOR REVIEW. THESE WOULD HAVE BEEN VERY USEFUL TO EVALUATE THE STENT ARCHITECTURE. FROM THE LIMITED IMAGES AVAILABLE, IT APPEARS THAT THE RIGHT ILIAC STENT HAS AN ABNORMAL ARCHITECTURE. THE STENT APPEARS ACCORDIONED IN ITS MID PORTION. THE PROXIMAL AND DISTAL PORTIONS OF THE STENT APPEAR TO HAVE NORMAL STENT ARCHITECTURE AND THE INTERSTICES ARE NORMAL IN APPEARANCE. THESE FINDINGS ARE SUSPICIOUS FOR LONGITUDINAL COMPRESSION OF THE STENT. FINAL IMAGES SHOW AN EXCELLENT ANGIOGRAPHIC RESULT. OBSERVATIONS: A SINGLE CD-ROM CONTAINING MULTIPLE CINE FILES IS SUBMITTED FOR REVIEW. INITIAL PELVIC ANGIOGRAM SHOWS CHRONIC OCCLUSION OF THE RIGHT COMMON ILIAC ARTERY. THERE IS STENOSIS OF THE DISTAL LEFT COMMON ILIAC ARTERY. BILATERAL FEMORAL ARTERY RETROGRADE ACCESS IS ACHIEVED AND KISSING STENTS ARE PLACED. BOTH SMART STENTS WERE SUPPOSED TO BE 8CM IN LENGTH AS PER CLINICAL REPORT. AFTER DEPLOYMENT, THE RIGHT ILIAC STENT APPEARS SIGNIFICANTLY LONGER THAN THE LEFT. CLOSE INSPECTION OF THE STENT ARCHITECTURE IS DIFFICULT AS NO UNSUBTRACTED IMAGES ARE PROVIDED. DSA IMAGES PROVIDED SHOW NORMAL STENT ARCHITECTURE ON THE LEFT AND ABNORMAL ARCHITECTURE ON THE RIGHT. THE RIGHT ILIAC STENT APPEARS TO HAVE ENLARGED INTERSTICES SUGGESTING LONGITUDINAL EXPANSION. A SECOND STENT IS PLACED ON THE LEFT SIDE AND FINAL IMAGES SHOW AN EXCELLENT ANGIOGRAPHIC RESULT. CONCLUSION: TWO CASES ARE SUBMITTED FOR REVIEW. CLINICAL INFORMATION IS LIMITED AND, IN FACT, IT IS UNCLEAR WHICH SET OF IMAGES BELONGS TO WHICH EVENT DESCRIPTION. NEVERTHELESS, BOTH CASES INVOLVE SMART STENTS THAT DID NOT DEPLOY TO THEIR EXPECTED LENGTHS. IN THE FIRST CASE, I BELIEVE THAT THIS IS DUE TO LONGITUDINAL COMPRESSION OF THE STENT RESULTING IN FORESHORTENING OF THE STENT. IN THE SECOND CASE, LONGITUDINAL EXPANSION RESULTED IN A LONGER THAN EXPECTED DEPLOYMENT LENGTH. DURING PLACEMENT, IT IS IMPERATIVE THAT THE TREATING PHYSICIAN HOLDS THE DEPLOYMENT HANDLE IN A FIXED POSITION DURING THE ENTIRE DEPLOYMENT. IF THE HANDLE IS MOVED FORWARD OR BACKWARD AFTER THE STENT HAS ACHIEVED INITIAL WALL APPOSITION THEN SEGMENTS OF COMPRESSION OR EXPANSION CAN BE CREATED. THIS CAN RESULT IN STENT LENGTHS WHICH ARE LONGER OR SHORTER THAN EXPECTED. IN MY OPINION, TECHNICAL FACTORS AND DEPLOYMENT TECHNIQUE CONTRIBUTED TO THE REPORTED EVENT. THIS DOES NOT APPEAR TO BE A CASE OF DEVICE FAILURE. THE PATIENT EXPERIENCED NO IMMEDIATE COMPLICATION AND WILL NOT LIKELY HAVE A CHANGE IN THEIR INTERMEDIATE OR LONG TERM PROGNOSIS.

    Description of Event or Problem · 1

    THE PRODUCT SHOULD CONTAIN A 8CM STENT; HOWEVER, THE PHYSICIAN FELT THAT THE STENT WAS 6CM. IT WAS REPORTED THAT A 8CM BALLOON WAS TOO LONG FOR THE STENT, BUT A 6CM BALLOON FIT THE STENT, THEREFORE HE FELT THAT THE STENT WAS 2 CM TOO SHORT. SINCE A SHORTER STENT WAS IMPLANTED, THE SURGEON HAS TO IMPLANT ANOTHER STENT. THE PATIENT STATUS WAS REPORTED AS "FINE."

    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 15187017

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention