BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3083293 · Received April 29, 2013

    Report

    Report Number
    2024168-2013-02668
    Event Type
    Death
    Date Received
    April 29, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    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. CONCOMITANT PRODUCTS: GUIDE WIRES: WHISPER, PROWATER, PILOT 150, PILOT 50, WHISPER XTRA SUPPORT, CHOICE PT STENTS: XIENCE XPEDITION-1074250-08, LOT 2090341, SERIAL (B)(4); 1074250-23, LOT 2091441, SERIAL (B)(4); 1074250-08, LOT 2090441, SERIAL (B)(4); 1074250-08, LOT 3012241, SERIAL (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY WITH THIS IMPLANTED 2.5X15 STENT AND THE STENT REMAINS IN THE PATIENT. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE ELECTRONIC XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE, AS A KNOWN ADVERSE EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ON AN IMPELLA DEVICE AT THE START OF THE PROCEDURE. THE 3.0X18 XIENCE XPEDITION WAS UNABLE TO CROSS THE HEAVILY CALCIFIED AND HEAVILY TORTUOUS TARGET LESION IN THE LEFT MAIN TO THE OSTIAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY DUE TO THE ANATOMY. THIS DID NOT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. FIVE SMALLER XIENCE XPEDITIONS (2.5 DIAMETER) WERE SUCCESSFULLY IMPLANTED IN THE PATIENT; HOWEVER, THE PATIENT EXPIRED DURING THE PROCEDURE DUE TO POOR CARDIAC OUTPUT. REPORTEDLY, THE PHYSICIAN DOES NOT BELIEVE THAT THE XIENCE XPEDITION STENTS ARE RELATED TO THE PATIENT DEMISE. THE PATIENT DIED DUE TO POOR CARDIAC OUTPUT AND A WEAK HEART. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185930 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2101941

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death