BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1925625 · Received December 14, 2010

    Report

    Report Number
    2024168-2010-02733
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    June 30, 2010
    Report Date
    November 19, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CLOPIDOGREL, ASPIRIN. VESSEL CLOSURE: ANGIO-SEAL. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND RE-STENOSIS ARE LISTED IN THE XIENCE V INSTRUCTIONS FOR USE, AS KNOWN ADVERSE EVENTS 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 OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2008, THE PATIENT UNDERWENT STENTING IN THE LEFT MAIN CORONARY ARTERY (LMCA) WITH THE XIENCE V STENT. ON (B)(6) 2010, THE PATIENT EXPERIENCED MIDSTERNAL BURNING AND SHORTNESS OF BREATH WITH MINIMAL EXERTION. ON (B)(6) 2010, PER ANGIOGRAM, LEFT HEART CATHETERIZATION REVEALED 99% IN-STENT RESTENOSIS AND A DE NOVO 75% LESION IN THE LARGE RAMUS. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED AND THE EVENT RESOLVED. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. 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 8052961

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R