BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 7466204 · Received April 26, 2018

    Report

    Report Number
    2024168-2018-03112
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    April 5, 2018
    Report Date
    April 26, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648199509
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IT SHOULD BE NOTED THAT THE XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM, INSTRUCTIONS FOR USE, STATES: NOTE THE PRODUCT USE BY (EXPIRATION) DATE SPECIFIED ON THE PRODUCT LABEL. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE DEVICE EXPIRATION ISSUE APPEARS TO BE RELATED TO THE USE ERROR. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: THE DATE WAS FILED INCORRECTLY ON THE INITIAL MEDWATCH REPORT AS 04/09/2048, BUT SHOULD HAVE BEEN 04/09/2018.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN A SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL. AFTER IMPLANTING THE XIENCE ALPINE STENT, IT WAS NOTED TO BE EXPIRED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307497 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 5031041 08717648199509

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR