BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2944406 · Received February 5, 2013

    Report

    Report Number
    2024168-2013-00653
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. (B)(4) - INCORRECT ANATOMY. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE XIENCE PRIME STATES: THE XIENCE PRIME STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY ARTERY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY CALCIFIED, MILDLY TORTUOUS, RIGHT POSTERIOR TIBIA ARTERY, THE 2.5 X 38 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS INSERTED AND DURING ADVANCING BECAME CRIMPED AND THE SHAFT FRACTURED. THE DEVICE WAS REMOVED WITHOUT INCIDENT AND A SECOND XIENCE PRIME SDS USED IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48514 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2082041

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR