BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3112142 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03034
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF THROMBOSIS IS LISTED IN THE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM 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 ON (B)(6) 2013, THE 2.5 X 38 MM XIENCE XPEDITION STENT WAS IMPLANTED IN A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE RAMUS VESSEL. ON (B)(6) 2013, THE PATIENT TROPONIN LEVELS WERE ELEVATED AND ANGIOGRAPHY FOUND PROXIMAL STENT THROMBOSIS IN THE XIENCE XPEDITION STENT. DILATATION WAS PERFORMED AND AN ADDITIONAL STENT WAS PLACED TO TREAT THE THROMBOSIS SUCCESSFULLY. THE PHYSICIAN COMMENTED THAT HE BELIEVED THE PATIENT HAD PLAVIX RESISTANCE; THEREFORE, THE MEDICATION WAS CHANGED. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212003 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R