BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2964330 · Received February 15, 2013

    Report

    Report Number
    2024168-2013-00920
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. IT SHOULD BE NOTED THAT THE EIFU (SECTION 2.0) STATES: THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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 OVER 4 YEARS POST XIENCE V STENT IMPLANTATION IN A SAPHENOUS VEIN GRAFT TO OBTUSE MARGINAL ARTERY, THE PATIENT EXPERIENCED SEVERE ANGINA AND WAS HOSPITALIZED; 90% IN-STENT RESTENOSIS WAS FOUND AND WAS TREATED WITH IMPLANTATION OF A NON-ABBOTT STENT. ON (B)(6) 2012, THE EVENT RESOLVED AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66645 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 7110641

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R