BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3081493 · Received April 29, 2013

    Report

    Report Number
    2024168-2013-02644
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    January 1, 2012
    Report Date
    February 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. (B)(6) 2012 - ESTIMATED DATE OF EVENT (B)(6) 2010 - ESTIMATED DATE OF IMPLANT THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF OCCLUSION IS LISTED IN THE XIENCE V / XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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 OTHER XIENCE V DEVICE REFERENCED, IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RESEARCH PATHOLOGY OF AN EXPLANTED HEART FOUND 1 UNK XIENCE V STENT IMPLANTED WITHIN 1 NON-ABBOTT STENT IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY AND 1 UNK XIENCE V STENT WITHIN A NON-ABBOTT STENT IN THE PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY. BOTH XIENCE STENTS SHOWED NEOATHEROSCLEROSIS. THE CAUSE OF DEATH WAS NONSTENT RELATED CARDIAC DEATH. THE EVENT OCCURRED 720 DAYS POST STENT IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185791 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other XIENCE V STENT (X1)