BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3930445 · Received July 11, 2014

    Report

    Report Number
    2024168-2014-04493
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 17, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED DEVICE MALFUNCTIONS OR PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT RESTENOSIS OF THE STENTED SEGMENT OF THE ARTERY IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (IFU) AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. 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. THE RX XIENCE REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN UNKNOWN XIENCE STENT WAS IMPLANTED IN THE MID TO PROXIMAL LAD IN 2011. ON (B)(6) 2014 THE PATIENT WAS ADMITTED WITH RESTENOSIS PROXIMAL TO THE PREVIOUSLY IMPLANTED STENT. ON (B)(6) 2014, A 3.25 X 28 MM XIENCE V WAS IMPLANTED TO TREAT THE RESTENOSIS. THE PROCEDURE WAS SUCCESSFUL WITHOUT ANY ISSUES. THE PATIENT DID NOT TAKE THE ANTICOAGULATION MEDICATION AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014 WITH THROMBOSIS IN THE 3.25 X 28 MM XIENCE V STENT. THE THROMBOSIS WAS TREATED WITH AN UNKNOWN ASPIRATION CATHETER AND THEN UNKNOWN BALLOON ANGIOPLASTY WAS PERFORMED. AN UNKNOWN STENT WAS PLACED DISTAL TO THE FIRST IMPLANTED XIENCE STENT TO TREAT A DISSECTION CAUSED BY THE ASPIRATION CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT IS RECOVERING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408100 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R