BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2020876 · Received March 16, 2011

    Report

    Report Number
    2024168-2011-01784
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    December 29, 2009
    Report Date
    December 18, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. (B)(4) - NO PRE-DILATATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. DEATH AND THROMBOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT APPROXIMATELY THIRTEEN MONTHS POST DIRECT STENTING PROCEDURE IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH ONE 2.5 X 23 XIENCE V STENT AND IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH ONE 3.0 X 12 XIENCE V STENT, THE PATIENT DEVELOPED SHORTNESS OF BREATH AT HOME AND EMERGENCY MEDICAL PERSONNEL WERE CALLED. TREATMENT INCLUDED CARDIOPULMONARY RESUSCITATION, INTUBATION, DEFIBRILLATION FOR VENTRICULAR FIBRILLATION, EPINEPHRINE AND LIDOCAINE. UPON ARRIVAL TO THE EMERGENCY ROOM, THE PATIENT WAS UNRESPONSIVE, CYANOTIC WITH DILATED, FIXED PUPILS AND WAS PRONOUNCED DEAD. SUBSEQUENT, ADDITIONAL INFORMATION RECEIVED INDICATES POSSIBLE STENT THROMBOSIS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8051462

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death XIENCE V 3.0 X 12