BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2073139 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-03019
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 5, 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. THE STENT REMAINS IN THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. PERFORATION 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 IN A SAPHENOUS VEIN GRAFT (SVG), 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 (LENGTH LESS THAN OR EQUAL TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 MM. THE IFU CAUTIONS THAT: THE SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH LESIONS LOCATED IN SAPHENOUS VEIN GRAFTS. 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 DURING THE PROCEDURE IN THE SAPHENOUS VEIN GRAFT TO THE POSTERIOR DESCENDING ARTERY, A 3.5 XIENCE V STENT WAS DEPLOYED AND A PERFORATION OCCURRED. A JOSTENT GRAFTMASTER STENT GRAFT WAS DEPLOYED TO TREAT THE PERFORATION SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THOUGH REQUESTED, 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention