BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3790811 · Received May 5, 2014

    Report

    Report Number
    2024168-2014-02821
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    January 8, 2014
    Report Date
    April 12, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: DIL CATH: NC TREK (2.25X6, 2.25X15); OTHER: ASPIRIN. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDTION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM ELECTRONIC INSTRUCTIONS FOR USE, 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 THERE WAS UNSPECIFIED TREATMENT DONE IN A LEFT ANTERIOR DESCENDING ARTERY (LAD). A XIENCE XPEDITION STENT WAS IMPLANTED IN A 1ST LEFT POSTERIOR LATERAL ARTERY (LPL) AND A DISSECTION WAS SEEN REQUIRING ANOTHER UNPLANNED XIENCE XPEDITION 2.25 X 15 MM STENT TO BE IMPLANTED AS SUCCESSFUL TREATMENT. THERE WAS NO PROLONGED HOSPITALIZATION REPORTED. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267680 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3092341

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention CONCOMITANT MEDICAL DEVICES