BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6528647 · Received April 27, 2017

    Report

    Report Number
    2024168-2017-03726
    Event Type
    Injury
    Date Received
    April 27, 2017
    Date of Event
    April 4, 2017
    Report Date
    April 27, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648199271
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: RINATO, GUIDE CATHETER: HYPERION. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE TENKU RX IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED, CONCENTRIC, AND DE NOVO FIRST DIAGONAL ARTERY THAT WAS 90% STENOSED. AN UNSPECIFIED XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WHEN PLAQUE SHIFT OCCURRED AT THE ENTRANCE OF THE FIRST DIAGONAL. A 1.5 X 12 MM RX TENKU WAS BEING USED TO DILATE THE VESSEL WHEN THE BALLOON RUPTURED ON THE FIRST INFLATION AFTER 10 SECONDS AT 6 ATMOSPHERES. A NON-ABBOTT BALLOON WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307354 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 6110741 08717648199271

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other