BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3830984 · Received May 23, 2014

    Report

    Report Number
    2024168-2014-03324
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 2, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE V 3.5 X 23 MM STENT WAS IMPLANTED IN A CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). POST DEPLOYMENT, AN EDGE DISSECTION WAS NOTED AT THE PROXIMAL END OF THE STENT. A XIENCE V 3.5 X 15 MM STENT WAS IMPLANTED TO COVER THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307528 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3020441

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention