BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2072157 · Received April 28, 2011

    Report

    Report Number
    2024168-2011-02978
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    January 13, 2011
    Report Date
    April 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4) DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, RESTENOSIS, AND PAIN ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. 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 APPROXIMATELY FOURTEEN MONTHS POST STENTING PROCEDURE IN THE MID RIGHT CORONARY ARTERY WITH ONE 3.5 X 23 XIENCE V STENT, THE PATIENT EXPERIENCED CHEST AND JAW DISCOMFORT WITH EXERTION. ON (B)(6) 2011, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION IN THE INDEX TARGET LESION FOR 90% STENOSIS. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2011 AND THE PATIENT WAS DISCHARGED THE SAME DAY. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. THOUGH REQUESTED, 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 9061861

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention ASPIRINSTUDY DRUG - CLOPIDOGREL OR PLACEBO