BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2072861 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-03003
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    December 2, 2010
    Report Date
    February 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. IMPLANTED IN RESTENOSED STENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND RE-STENOSIS ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. IT WAS REPORTED THAT THE XIENCE STENT WAS IMPLANTED TO TREAT RE-STENOSIS OF A PREVIOUSLY IMPLANTED STENT. IT SHOULD BE NOTED THAT THE IFU STATES THAT 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 (LESS THAN OR EQUAL TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 MM. IN THIS CASE, IT IS UNKNOWN IF THIS CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST XIENCE V STENT IMPLANTATION IN THE PROXIMAL 1ST OBTUSE MARGINAL ARTERY, THE PATIENT PRESENTED WITH INCREASING CHEST PAIN AND WAS FOUND TO HAVE IN-STENT RESTENOSIS. MEDICATION WAS GIVEN AND PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. THERE WAS NO ADVERSE SEQUELA REPORTED AND ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. ALTHOUGH 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 9073042

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R