BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3903456 · Received June 30, 2014

    Report

    Report Number
    2024168-2014-04243
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    December 4, 2013
    Report Date
    June 17, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT BECAUSE IT WAS NOT RETURNED FOR INVESTIGATION. IN THIS CASE, THERE WERE NO REPORTED DEVICE MALFUNCTIONS OR PRODUCT DEFICIENCIES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE IF ANY CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT A STENTING PROCEDURE WITH PLACEMENT OF A 3.0 X 12 MM XIENCE XPEDITION STENT IN THE RIGHT POSTERIOR DESCENDING ARTERY. DURING THE STENTING PROCEDURE, PLAQUE SHIFT OCCURRED, CAUSING TWO LESIONS IN THE RIGHT CORONARY (RCA) ARTERY TO WORSEN AND REQUIRE ADDITIONAL STENTING. A 3.5 X 18 MM XIENCE XPEDITION WAS IMPLANTED IN THE DISTAL RCA AND A 4.0 X 18 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE PROXIMAL RCA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379648 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3051341

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention OTHER: ASPIRIN, CLOPIDOGREL.