BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6437388 · Received March 27, 2017

    Report

    Report Number
    2024168-2017-02542
    Event Type
    Malfunction
    Date Received
    March 27, 2017
    Date of Event
    March 2, 2017
    Report Date
    April 13, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL FILE NUMBER - (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: DILATATION CATHETER: SAPPHIRE 5.0 X 10 MM. GUIDE WIRE: SION BLUE, SION BLACK, RUNTHOUGH NS EXTRA FLOPPY, ROTA WIRE. GUIDE CATHETER: HYPERION 7F SPB3.5, KUSABI, CARAVEL MC 135 CM. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. 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 LESION IN THE LEFT MAIN. AFTER IMPLANTATION OF THE XIENCE ALPINE 4.0 X 18 MM AT THE LEFT MAIN, POST-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON CATHETER. AFTER POST-DILATATION, THE STENT SHORTENED AND WAS NOT COMPLETELY COVERING THE LESION. THE IMPLANTED STENT WAS NOT CLEAR BY ANGIOGRAPHY. SO THE SHORTENED STENT WAS CONFIRMED BY IMAGING DEVICE. AN UNSCHEDULED NEW XIENCE ALPINE 4.0 X 18 MM WAS IMPLANTED TO COVER THE LESION. NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219941 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 6100341

    Patients

    Seq Age Sex Outcome Treatment
    1