BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3923803 · Received July 9, 2014

    Report

    Report Number
    2024168-2014-04421
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 15, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PATIENT EFFECT OF DISSECTION IS A KNOWN POTENTIAL PATIENT EFFECT AS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU). ALTHOUGH, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: IT WAS REPORTED THAT THE DEVICE WAS NOT AVAILABLE FOR EVALUATION; HOWEVER, THE STENT DELIVERY SYSTEM WAS RETURNED. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION; HOWEVER, THIS INCIDENT WAS REPORTED WITH THE ABSENCE OF ANY DEVICE MALFUNCTION. BASED ON VISUAL 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 THE REPORTED EVENT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TREATING A MILDLY TORTUOUS, MILDLY CALCIFIED, DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 3.5X18MM XIENCE XPEDITION WAS IMPLANTED AND A DISSECTION WAS OBSERVED. THE DISSECTION WAS TREATED WITH AN ADDITIONAL XIENCE XPEDITION STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401587 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4021941

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention