BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART FLEX 5X120 VAS 120CM

    MDR report key: 11661144 · Received April 13, 2021

    Report

    Report Number
    9616099-2021-04404
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 17, 2021
    Report Date
    May 17, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K130981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING USE IN PATIENT, THE SMARTFLEX VASCULAR (VAS) 5MM X 120MM X 120CM SELF-EXPANDING STENT IS HALF RELEASED AND CANNOT BE FULLY RELEASED. THE TARGET LESION IS THE MIDDLE AND DISTAL SEGMENT OF SUPERFICIAL FEMORAL ARTERY WITH SEVENTY PERCENT STENOSIS AND MEDIUM CALCIFICATION. A SABER 5-150MM BALLOON WAS USED FOR PRE DILATION TO REDUCE STENOSIS TO TEN PERCENT. THE TARGET LESION IS 5MM. THE RATIO OF SIZE OF VESSEL AND STENT DIMETER ARE 1:1. THE TARGET LESION VESSEL LENGTH IS 130MM. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOTHING UNUSUAL OR DAMAGES NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. A COMPETITOR'S 6F SHEATH AND GUIDEWIRE WAS USED DURING THE PROCEDURE. DELIVERY OF THE SDS TO THE LESION WAS CONTRALATERAL. THERE WAS NO DIFFICULTY TRACKING THE DEVICE THROUGH THE LESION. THE STENT DELIVERY SYSTEM HOWEVER DID PASS THROUGH AN ACUTE BEND. THE SDS DID NOT PASS THROUGH A PREVIOUSLY PLACED STENT. THE SDS WAS ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION PRIOR TO ATTEMPTING THE STENT DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS RETURNED FOR ANALYSIS. ONE NON-STERILE SMART FLEX 5X120 VAS 120CM STENT DELIVERY SYSTEM WAS RECEIVED FOR ANALYSIS INSIDE A PLASTIC BAG. THE VALVE OF THE UNIT WAS RECEIVED CLOSED. PER VISUAL ANALYSIS, THE STENT OF THE UNIT WAS RECEIVED 3.0 CM PARTIALLY. NO OTHER ANOMALIES OBSERVED. PER FUNCTIONAL ANALYSIS, DEPLOYMENT TEST WAS PERFORMED ON THE UNIT. THE TUOHY BORST VALVE OF THE STENT DELIVERY SYSTEM WAS OPENED, AND THE STENT DEPLOYMENT TEST WAS SUCCESSFULLY PERFORMED BY RETRACTING THE OUTER SHEATH WHILE HOLDING THE INNER SHAFT IN A FIXED POSITION. THE STENT WAS FULLY UNSHEATHED/EXPANDED AS EXPECTED. NO ANOMALIES FOUND. PER DIMENSIONAL ANALYSIS, THE USABLE STENT DELIVERY SYSTEM LENGTH OF THE UNIT WAS MEASURED, AND IT WAS FOUND WITHIN SPECIFICATION. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 233354 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿STENT DELIVERY SYSTEM (SDS)-SES-DEPLOYMENT DIFFICULTY - PARTIAL DEPLOYMENT¿ WAS CONFIRMED SINCE THE STENT OF THE UNIT WAS RECEIVED FOR ANALYSIS 3.0 CM PARTIALLY DEPLOYED. HOWEVER, THE EXACT CAUSE OF THE STENT DELIVERY SYSTEM PARTIAL DEPLOYMENT CONDITION COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. IT IS PROBABLE THAT PROCEDURAL FACTORS AND OR HANDLING FACTORS SUCH AS THE USER¿S INTERACTION WITH THE DEVICE AS WELL AS VESSEL CHARACTERISTICS (SEVENTY PERCENT STENOSIS) AND TRANSPORTATION/PACKAGING OF THE RETURNED DEVICE MAY HAVE CONTRIBUTED TO THE STENT PARTIAL DEPLOYMENT CONDITION OF THE UNIT, THE WAY IT WAS RECEIVED FOR ANALYSIS. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE, ¿IF RESISTANCE IS ENCOUNTERED AT ANY TIME DURING THE INSERTION PROCEDURE, DO NOT FORCE PASSAGE. RESISTANCE MAY CAUSE DAMAGE TO THE STENT OR LUMEN. IF RESISTANCE OCCURS DURING MOVEMENT THROUGH THE SHEATH, CAREFULLY WITHDRAW THE STENT SYSTEM. ONCE STENT DEPLOYMENT HAS BEGUN, THE STENT MUST BE FULLY DEPLOYED. THE SYSTEM IS NOT DESIGNED FOR STENT REPOSITIONING OR RECAPTURING. IF RESISTANCE IS FELT WHEN INITIALLY RETRACTING THE OUTER SHEATH, DO NOT FORCE DEPLOYMENT. CAREFULLY WITHDRAW THE STENT SYSTEM WITHOUT DEPLOYING THE STENT. PRIOR TO STENT DEPLOYMENT, REMOVE ALL SLACK FROM THE CATHETER DELIVERY SYSTEM.¿ NEITHER THE PHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN.

    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.

    Description of Event or Problem · 1

    DURING USE IN PATIENT, THE 5MM X 120MM X 120CM SMARTFLEX VASCULAR (VAS) SELF-EXPANDING STENT IS HALF RELEASED AND CANNOT BE FULLY RELEASED. THE TARGET LESION IS THE MIDDLE AND DISTAL SEGMENT OF SUPERFICIAL FEMORAL ARTERY WITH SEVENTY PERCENT STENOSIS AND MEDIUM CALCIFICATION. A SABER 5-150MM BALLOON WAS USED FOR PRE DILATION TO REDUCE STENOSIS TO TEN PERCENT. THE TARGET LESION IS 5MM. THE RATIO OF SIZE OF VESSEL AND STENT DIMETER ARE 1:1. THE TARGET LESION VESSEL LENGTH IS 130MM. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOTHING UNUSUAL OR DAMAGES NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. A COMPETITOR'S 6F SHEATH AND GUIDEWIRE WAS USED DURING THE PROCEDURE. DELIVERY OF THE SDS TO THE LESION WAS CONTRALATERAL. THERE WERE NO DIFFICULTY TRACKING THE DEVICE THROUGH THE LESION. THE STENT DELIVERY SYSTEM HOWEVER DID PASS THROUGH AN ACUTE BEND. THE SDS DID NOT PASS THROUGH A PREVIOUSLY PLACED STENT. THE SDS WAS ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION PRIOR TO ATTEMPTING THE STENT DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559266 SMART FLEX 5X120 VAS 120CM CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CORPORATION SF05120MV 233354

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK.