BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2964325 · Received February 15, 2013

    Report

    Report Number
    2024168-2013-00918
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 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. 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS 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 BIFURCATION LESION IN THE LEFT MAIN (LM) ARTERY. AFTER THE 3.0 X 23 XIENCE XPEDITION STENT WAS DEPLOYED SUCCESSFULLY IN THE LEFT ANTERIOR DESCENDING ARTERY LESION, AN UNKNOWN GUIDE WIRE WAS ADVANCED TO THE DIAGONAL VESSEL. THE 2.75 MM XIENCE XPEDITION STENT WAS IMPLANTED SUCCESSFULLY IN THE DIAGONAL VESSEL. DURING REMOVAL OF THE GUIDE WIRE IN THE DIAGONAL, RESISTANCE WAS NOTED WITH THE 2.75 MM STENT DELIVERY SYSTEM (SDS). THE SDS WAS REMOVED WITH NO DAMAGE TO THE IMPLANTED STENT. THE PROXIMAL LEFT CIRCUMFLEX (LCX) LESION WAS THEN PRE-DILATED AND A 3.5 X 15 MM XIENCE XPEDITION STENT WAS IMPLANTED IN LM. THE VESSEL WAS RE-WIRED AND A BALLOON WAS ADVANCED THROUGH THE LM STENT CELL FOR DILATATION OF THE LCX. THE 3.5 X 12 MM XIENCE XPEDITION SDS WAS ADVANCED THROUGH THE LM STENT CELL TO THE LCX. THE WIGGLE GUIDE WIRE WAS THEN ADVANCED, BUT DID NOT CROSS TO THE LESION AND WAS EXCHANGED TO A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE. TWO NC BALLOONS WERE USED FOR POST-DILATATION AT 22 ATMOSPHERES (ATM), ONE AT A TIME. THE BALLOONS WERE THEN INFLATED SIMULTANEOUSLY TO 14 ATM. A 5.0 BALLOON WAS THEN USED FOR POST-DILATATION ON THE PROXIMAL LM STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68077 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR GUIDE CATH: 8F