BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 5872393 · Received August 12, 2016

    Report

    Report Number
    2024168-2016-05362
    Event Type
    Malfunction
    Date Received
    August 12, 2016
    Date of Event
    July 18, 2016
    Report Date
    September 15, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: CATALOG NUMBER CHANGED FROM 1120350-28 TO 1120350-38. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE INVESTIGATION DETERMINED THE DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. 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 SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED, RESTENOSED, BELOW THE BIRFURCATION LESION IN THE CIRCUMFLEX (CX) ARTERY. THE XIENCE ALPINE 3.5 X 28 MM GOT STUCK INSIDE OF A NON-ABBOTT 7FR GUIDING CATHETER DUE TO THE TORTUOSITY AND BOTH DEVICES WERE REMOVED AS A UNIT WITH NO ISSUE. ANOTHER XIENCE WAS DEPLOYED AND THEN THE XIENCE ALPINE 3.0 X 28 MM COULD NOT CROSS THE DEPLOYED STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524953 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 6020141

    Patients

    Seq Age Sex Outcome Treatment
    1