BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    MDR report key: 3060683 · Received April 16, 2013

    Report

    Report Number
    2024168-2013-02309
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    November 8, 2012
    Report Date
    March 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT IS ESTIMATED AS (B)(6) 2012 FAILURE TO FOLLOW STEPS/INSTRUCTIONS, EXCESSIVE FORCE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. ADDITIONALLY, A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED, BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THE WARNINGS SECTION OF THE HI-TORQUE GUIDE WIRE INSTRUCTIONS FOR USE (IFU) STATES: DO NOT TORQUE A GUIDE WIRE IF THE TIP BECOMES ENTRAPPED WITHIN THE VASCULAR. FAILURE TO DO SO MAY RESULT IN VESSEL TRAUMA, GUIDE WIRE DAMAGE, GUIDE WIRE TIP SEPARATION, OR STENT DAMAGE. IF RESISTANCE IS OBSERVED AT ANY TIME, DETERMINE THE CAUSE UNDER FLUOROSCOPY AND TAKE REMEDIAL ACTION AS NEEDED. THE IFU FURTHER WARNS TO CONSIDER THAT IF SECONDARY WIRE IS PLACED IN A BIFURCATION BRANCH, THIS WIRE MAY NEED TO BE RETRACTED PRIOR TO STENT DEPLOYMENT BECAUSE THERE IS ADDITIONAL RISK THAT THE SECONDARY WIRE MAY BECOME ENTRAPPED BETWEEN THE VESSEL WALL AND THE STENT. IN THIS CASE, IT APPEARS THAT THE REPORTED FORCE WAS NECESSARY IN AN ATTEMPT TO RETRACT THE ENTRAPPED WIRE.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW OF THE ARTICLE, PROCEDURAL TRAUMA RISKS LONGITUDINAL SHORTENING OF THE PROMUS ELEMENT STENT PLATFORM. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH RECURRENT ANGINA. THE TARGET LESION WAS A CRITICAL STENOSIS IN THE PROXIMAL PART OF A SAPHENOUS VEIN GRAFT TO THE FIRST OBTUSE MARGINAL BRANCH OF THE CIRCUMFLEX (LCX) , AND PCI WAS UNDERTAKEN. GUIDE SUPPORT WAS PROBLEMATIC AND 2 BALANCE GUIDE WIRES WERE USED WERE NECESSARY TO FACILITATE DEVICE DELIVERY. A FILTER DEVICE WAS PLACED AND PRE-DILATATION WAS PERFORMED. A NON-ABBOTT STENT WAS IMPLANTED AND THE FILTER WAS REMOVED WITHOUT ISSUE; HOWEVER, DURING REMOVAL OF THE JAILED GUIDE WIRE, WHICH HAD BEEN NECESSARY TO PROVIDE THE SUPPORT REQUIRED FOR STENT DELIVERY, THE STENT BECAME DEFORMED AND WAS DRAGGED FROM THE LESION TO THE OSTIUM OF THE GRAFT. RADIOPAQUE DOUBLE LAYERING OF STRUTS WAS VISIBLE, INDICATING THAT THE STENT HAD BECOME SHORTENED. SIGNIFICANT FORCE WAS USED TO REMOVE THE JAILED WIRE, WHICH HAD BECOME ENTWINED IN THE DOUBLE LAYER OF STENT STRUTS IN THE PROXIMAL PART OF THE STENT. AFTER THE GUIDE WIRE WAS REMOVED, THE TIP WAS NOTED TO BE FREE IN THE AORTA. THE STENT WAS POST-DILATED TO FACILITATE FURTHER STENT DELIVERY TO THE TARGET LESION. A 3.0/12-MM XIENCE PRIME STENT WAS IMPLANTED IN THE ORIGINAL LESION IN THE PROXIMAL SUCCESSFULLY. A SECOND XIENCE V STENT WAS IMPLANTED AT THE OSTIUM INSIDE THE DEFORMED NON-ABBOTT STENT. THE END-ANGIOGRAPHIC RESULT WAS ACCEPTABLE, AND REMAINED SATISFACTORY AT 6-MONTH FOLLOW-UP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162783 HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention STENT: 3.0/16 MM PROMUS ELEMENT