BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2040398 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02395
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    September 9, 2010
    Report Date
    March 11, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. RESTENOSIS IS A KNOWN ADVERSE EVENT 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. SINCE IT WAS REPORTED THAT THE XIENCE V STENT WAS IMPLANTED TO TREAT IN-STENT RESTENOSIS, IT SHOULD BE NOTED THAT THE XIENCE V IFU 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. THE IFU CAUTIONS THAT: THE SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH IN-STENT RESTENOSIS. IN THIS CASE, IT CANNOT BE DETERMINED WHETHER THE IFU DEVIATION CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, A 3.5 X 15 MM XIENCE V STENT WAS PLACED TO TREAT RESTENOSIS OF A XIENCE V STENT WHICH HAD BEEN IMPLANTED ON (B)(6) 2009, IN THE OSTIAL RIGHT CORONARY ARTERY. ON (B)(6) 2010, THE PATIENT WAS REHOSPITALIZED. ANGIOGRAPHY REVEALED RESTENOSIS IN THE 3.5 X 15 XIENCE V STENT, WHICH WAS TREATED WITH ANGIOPLASTY. NO ADDITIONAL INFORMATION WAS 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 0032441

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R