BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRO LL EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM

    MDR report key: 4100066 · Received September 18, 2014

    Report

    Report Number
    2024168-2014-06018
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 25, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE XIENCE PRO LL IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEAVILY CALCIFIED, MID RIGHT CORONARY ARTERY PROCEDURE, DURING ADVANCEMENT THE PROXIMAL SHAFT OF A 3.5 X 33MM XIENCE PRO STENT DELIVERY SYSTEM SEPARATED INTO TWO PIECES. THE SEPARATION WAS OUTSIDE THE ANATOMY SO IT WAS EASILY REMOVED. ANOTHER NON-SPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT EFFECTS OR A CLINICALLY SIGNIFICANT DELAY REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578365 XIENCE PRO LL EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4022841

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR