BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4243953 · Received November 11, 2014

    Report

    Report Number
    2024168-2014-07366
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 17, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MILDLY TORTUOUS, 80-90% STENOSED, PROXIMAL RIGHT CORONARY ARTERY. THE PATIENT WAS BROUGHT TO HOSPITAL WITH SEVERE CHEST PAIN. USING A DIRECT STENTING RADIAL APPROACH THE 3.0X23 MM XIENCE V STENT WAS DEPLOYED IN THE TARGET LESION. POST-DILATATION WAS PERFORMED USING A 3.0X12 NC BALLOON CATHETER. ANGIOGRAPHY REVEALED A DISSECTION AT THE PROXIMAL END OF THE STENT. A 3.5X15 MM XIENCE V WAS DEPLOYED TO TREAT THE DISSECTION. THE PATIENT IS STABLE NOW. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725149 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3120641

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention