BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2895163 · Received January 3, 2013

    Report

    Report Number
    2024168-2013-00023
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 6, 2012
    Report Date
    December 10, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), AS KNOWN ADVERSE EVENTS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2012 WITH A MYOCARDIAL INFARCTION. ON (B)(6) 2012, THE 2.75 X 15 MM XIENCE V STENT WAS IMPLANTED INTO THE RAMUS ARTERY FOR TREATMENT. ON (B)(6) 2012, THE PATIENT PRESENTED WITH CHEST PAIN AND IT WAS FOUND THAT THE XIENCE V STENT HAD 90% IN-STENT RESTENOSIS. THE PATIENT WAS SENT FOR TRIPLE BY-PASS SURGERY ON (B)(6) /2012 FOR TREATMENT, AND IS RECOVERING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3138 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2032141

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R| S