BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3936255 · Received July 15, 2014

    Report

    Report Number
    2024168-2014-04535
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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 THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: THE XIENCE XPEDITION 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 REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 4.0 X 15 MM XIENCE XPEDITION STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED PROXIMAL RIGHT VEIN GRAFT. THE DELIVERY SYSTEM BALLOON WAS INFLATED AND, DUE TO THE CALCIFICATION, THE STENT WATERMELON-SEEDED TO THE PROXIMAL PART OF THE DELIVERY SYSTEM BALLOON, BUT REMAINED ON THE BALLOON. THE DEVICE WAS PULLED BACK INTO THE DELIVERY CATHETER, WITH THE BALLOON REMAINING INFLATED TO KEEP THE STENT ON THE DELIVERY SYSTEM. THE 6 FRENCH GUIDE SHEATH WAS EXCHANGED FOR A 10 FRENCH GUIDE SHEATH AND THE BALLOON WAS DEFLATED. THE DEVICE WAS REMOVED AS A SINGLE UNIT, WITH THE STENT DISLODGING. A SNARE WAS THEN ADVANCED AND WAS ABLE TO REMOVE THE STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. THE PHYSICIAN THEN CHOSE TO END THE PROCEDURE, AS IT WAS FELT THAT THE PATIENT ANATOMY/CALCIFICATION WOULD NOT ALLOW ANY OTHER DEVICE TO BE IMPLANTED. PATIENT IS BEING TREATED MEDICALLY AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412832 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 304174A

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention