BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2061089 · Received April 18, 2011

    Report

    Report Number
    2024168-2011-02688
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. FACTORS WHICH MAY CONTRIBUTE TO RESISTANCE DURING ADVANCEMENT OF THE STENT DELIVERY SYSTEM (SDS) INTO THE GUIDING CATHETER INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, STENT IMPLANT OUTER DIAMETER, DAMAGE TO THE STENT IMPLANT, KINKS, BENDS, OBSTRUCTIONS IN THE GUIDING CATHETER LUMEN, OR DAMAGE TO THE GUIDING CATHETER. THE SDS AND GUIDING CATHETER USED DURING THE PROCEDURE WAS NOT RETURNED, AND THEREFORE IT COULD NOT BE DETERMINED HOW THEY MAY HAVE CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED. REPORTEDLY, AN ATTEMPT WAS MADE TO DRAW A NEGATIVE ON THE BALLOON AND THE STENT IMPLANT DISLODGED IN THE PROXIMAL AREA OF THE GUIDING CATHETER. THE PROMUS INSTRUCTIONS FOR USE (IFU) CAUTIONS: WHILE INTRODUCING THE DELIVERY SYSTEM INTO THE VESSEL, DO NOT INDUCE NEGATIVE PRESSURE ON THE DELIVERY SYSTEM. THIS MAY CAUSE DISLODGEMENT OF THE STENT FROM THE BALLOON. IN THIS INSTANCE, IT IS POSSIBLE AN INTERACTION BETWEEN THE SDS AND THE GUIDING CATHETER DURING ADVANCEMENT MAY HAVE CAUSED DAMAGE TO THE STENT IMPLANT WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY ADVANCING THE SDS, ALTHOUGH THIS CANNOT BE CONFIRMED. THEN AS A NEGATIVE WAS DRAWN ON THE BALLOON, THIS WOULD HAVE CAUSED THE STENT TO LOOSEN AND ULTIMATELY DISLODGE INSIDE THE GUIDING CATHETER DURING RETRACTION. TO HELP ENSURE THIS DIFFICULTY IS NOT RELATED TO A MANUFACTURING DEFICIENCY, THE STENT IS CHECKED FOR PROPER STRUT DIMENSIONS, AND THE STENT IS INSPECTED AT MULTIPLE STEPS IN THE PROCESS FOR STENT DAMAGE ON THE MANUFACTURING LINE. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE. A DEFINITIVE CAUSE OF THE DIFFICULTY TO ADVANCE THE SDS IN THE GUIDING CATHETER COULD NOT BE DETERMINED; HOWEVER, THE STENT DISLODGMENT IS LIKELY DUE TO THE IFU DEVIATION. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND THERE HAVE BEEN NO RELATED INCIDENTS REPORTED FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS FOR DIFFICULT TO POSITION THE STENT DELIVERY SYSTEM IN THE GUIDING CATHETER OR STENT RETENTION ISSUES REPORTED FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DIAGONAL VESSEL. THE GUIDE WIRE WAS PLACED AND THE PROMUS WAS ADVANCED OVER THE GUIDE WIRE; HOWEVER, RESISTANCE WAS MET DURING ADVANCEMENT INTO THE GUIDING CATHETER. IT WAS NOTED THAT AN ATTEMPT WAS MADE TO DRAW NEGATIVE ON THE BALLOON; HOWEVER, IT WAS REALIZED THAT THIS WAS INCORRECT PROCEDURE, AND THE DEVICE WAS REMOVED. IT WAS OBSERVED THAT THE STENT WAS NOT ON THE BALLOON. THE GUIDING CATHETER WAS REMOVED, AND THE STENT WAS FOUND IN THE PROXIMAL AREA OF THE GUIDING CATHETER, OUTSIDE THE ANATOMY. ANOTHER UN-SPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0062941

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR