BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6393295 · Received March 9, 2017

    Report

    Report Number
    2024168-2017-01959
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Date of Event
    February 17, 2017
    Report Date
    March 9, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648205484
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT AND DEVICE CODES IN F10 WERE CODED BY THE MANUFACTURER. PATIENT CODES: (B)(4). DEVICE CODES: (B)(4). INTERNAL FILE NUMBER - 315100/1-1: DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED MATERIAL DEFORMATION WAS ABLE TO BE CONFIRMED. THE REPORTED FAILURE TO ADVANCE AND THE REPORTED DIFFICULTY TO REMOVE WERE UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT AS THEY WERE BASED ON OPERATIONAL CIRCUMSTANCES. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THAT AS THE STENT DELIVERY SYSTEMWAS ADVANCED RESISTANCE WAS MET WITH THE TORTUOUS AND PARTIALLY CALCIFIED ANATOMY RESULTING IN THE REPORTED FAILURE TO ADVANCE. AS THE DEVICE WAS WITHDRAWN INTERACTION WITH THE TORTUOUS AND PARTIALLY CALCIFIED ANATOMY AND/OR OTHER DEVICES RESULTED IN THE REPORTED/NOTED STENT DAMAGES THUS RESULTING IN THE REPORTED DIFFICULTY TO REMOVE. 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 OTHER INCIDENTS FROM THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TORTUOUS AND PARTIALLY CALCIFIED LESION IN THE LEFT MAIN, LEFT ANTERIOR DESCENDING, AND FIST DIAGONAL BRANCH ARTERY. A 2.25X28MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY. THE SDS WAS PULLED AND IT WAS NOTICED THAT THE STENTS INTEGRITY WAS DAMAGED AND SOME PORTIONS OF THE STENT WERE FLARING. IT WAS DECIDED THE STENT WAS NOT DEPLOYABLE. THE DEVICE WAS REMOVED AND SOME RESISTANCE WAS NOTICED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174485 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 6052641 08717648205484

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR