BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3830910 · Received May 23, 2014

    Report

    Report Number
    2024168-2014-03319
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    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 XPEDITION 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 TARGET LESION WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED IN THE MID RIGHT CORONARY ARTERY (RCA). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED COMPLIANT BALLOON. DURING DEPLOYMENT OF THE 2.5 X 18 MM XIENCE XPEDITION STENT, A LINEAR DISSECTION WAS OBSERVED. BALLOON INFLATIONS WERE PERFORMED AND A 2.5 X 12 MM XIENCE XPEDITION STENT WAS IMPLANTED OVERLAPPING THE FIRST STENT TO TREAT THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307709 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3070241

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention