BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3930132 · Received July 11, 2014

    Report

    Report Number
    2024168-2014-04463
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 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 MODERATELY TORTUOUS, HEAVILY CALCIFIED AND 90% STENOSED DISTAL RIGHT CORONARY ARTERY. MULTIPLE PRE-DILATATIONS WERE PERFORMED WITH A NON-ABBOTT BALLOON CATHETER UP TO 16 ATMOSPHERES. AN ATTEMPT WAS MADE TO CROSS THE LESION WITH A 2.5 X 18 MM XIENCE XPEDITION STENT DELIVERY SYSTEM; HOWEVER, THE SDS COULD NOT CROSS THE LESION DUE TO THE CALCIFICATION AND THE DISTAL STENT STRUTS FLARED. WHEN REMOVING THE DEVICE, RESISTANCE WAS MET WITH THE ANATOMY AND THE PROXIMAL STENT STRUTS FLARED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 2.5 X 15 MM XIENCE XPEDITION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406747 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4010341

    Patients

    Seq Age Sex Outcome Treatment
    1