BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2040159 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02365
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    May 6, 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
    NY, 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 XIENCE V 3.0 X 23 MM (B)(6) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, ISCHEMIA, MYOCARDIAL INFARCTION, AND RESTENOSIS ARE KNOWN ADVERSE EVENTS 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 2.5 X 23MM XIENCE V STENT WAS IMPLANTED TO TREAT RESTENOSIS OF A PREVIOUSLY IMPLANTED STENT, 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 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 APPROXIMATELY SEVEN MONTHS POST XIENCE V STENTING PROCEDURE WITH ONE 2.5 X 23 STENT IMPLANTATION IN A RESTENOSED, NON-ABBOTT STENTED LESION, IN THE FIRST OBTUSE MARGINAL ARTERY, ONE 3.0 X 23 STENT, WHICH WAS DIRECTLY STENTED WITHOUT PRE-DILATATION IN THE MID LEFT ANTERIOR DESCENDING ARTERY AND ONE 2.5 X 23 STENT IN THE FIRST DIAGONAL ARTERY, THE PATIENT WAS HOSPITALIZED WITH A COUGH, SHORTNESS OF BREATH AND CHEST PAIN. ON (B)(6) 2010, CARDIAC ENZYMES (TROPONIN I) WERE ELEVATED, THE ECG SHOWED REVERSIBLE CHANGE CONSISTENT WITH ISCHEMIA AND THE PATIENT WAS DIAGNOSED WITH A NON-ST ELEVATION MYOCARDIAL INFARCTION. CARDIAC CATHETERIZATION SHOWED A PATENT STENT IN THE FIRST DIAGONAL ARTERY, NEW LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND RESTENOSIS IN THE FIRST OBTUSE MARGINAL ARTERY WHICH WAS NOT TREATED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION STENTING IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY TARGET VESSEL, NON-TARGET LESION ON (B)(6) 2010. THE PATIENT'S CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2010. 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 8102362

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| S ASPIRIN, CLOPIDOGREL