BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3822285 · Received May 20, 2014

    Report

    Report Number
    2024168-2014-03215
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 29, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIRST 3.0 X 38 MM XIENCE PRIME STENT MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE SHAFT SEPARATION WAS CONFIRMED. THE FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL AND DIMENSIONAL ANALYSIS 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 THIS COMPLAINT. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE HEAVILY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A ROTABLADER WAS USED TO REMOVE CALCIUM IN THE LESION. THE 3.0X38MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION AND THE PROXIMAL SHAFT SEPARATED. REPORTEDLY, THERE WAS NO INTERACTION OF DEVICES. THE SDS WAS REMOVED WITHOUT ANY REPORTED ISSUE. A SECOND 3.0X38MM XIENCE PRIME SDS FAILED TO CROSS THE LESION AND THE PROXIMAL SHAFT SEPARATED. REPORTEDLY, THERE WAS NO INTERACTION OF DEVICES. THE SDS WAS REMOVED WITHOUT ANY REPORTED ISSUE. A 3.0X38MM XIENCE XPEDITION SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300633 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3091941

    Patients

    Seq Age Sex Outcome Treatment
    1