BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1920290 · Received December 10, 2010

    Report

    Report Number
    2024168-2010-02666
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    January 26, 2010
    Report Date
    February 26, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2009 THAT THE PATIENT UNDERWENT STENTING IN THE FIRST DIAGONAL ARTERY WITH ONE 2.25 X 18 XIENCE V STENT. ON (B)(6) 2010, THE PATIENT EXPERIENCED CHEST PAIN AND WAS FOUND TO HAVE A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A NEW LESION PROXIMAL TO THE STUDY STENT IN THE DIAGONAL. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION ON (B)(6) 2010. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. THIS EVENT WAS ADJUDICATED BY THE CLINICAL EVENTS COMMITTEE AS A TARGET LESION REVASCULARIZATION FOR IN-STENT RESTENOSIS IN THE FIRST DIAGONAL AND A NON-TARGET LESION IN THE MID LAD. 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 90217P5

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R